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An Observational Study of Avastin (Bevacizumab) in Patients With HER2-metastatic or Locally Advanced Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01461044
Recruitment Status : Completed
First Posted : October 27, 2011
Results First Posted : January 26, 2016
Last Update Posted : January 26, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Observational
Study Design Observational Model: Cohort
Condition Breast Cancer
Enrollment 228
Recruitment Details  
Pre-assignment Details In total, 228 participants were included but 1 participant did not fulfill the inclusion criteria, therefore not included in the analysis. Inclusion (baseline) here was the time after the retrospective phase and at the start of prospective phase.
Arm/Group Title Bevacizumab: Hormone Receptor-Positive (HR+) Breast Cancer Bevacizumab: Triple Negative (TN) Breast Cancer
Hide Arm/Group Description Participants with human epidermal growth factor receptor 2 negative (HER2-) metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for greater than or equal to (>=) 12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months. Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Period Title: Overall Study
Started 150 77
Participants Alive at Inclusion 127 58
Completed 80 37
Not Completed 70 40
Reason Not Completed
Death             58             35
Lost to Follow-up             12             5
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer Total
Hide Arm/Group Description Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months. Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months. Total of all reporting groups
Overall Number of Baseline Participants 135 67 202
Hide Baseline Analysis Population Description
Efficacy population included all participants who did not violate any inclusion or exclusion.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 135 participants 67 participants 202 participants
55.0  (12.0) 55.6  (10.3) 55.2  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 135 participants 67 participants 202 participants
Female
135
 100.0%
67
 100.0%
202
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants Who Were Disease-Free for at Least 12 Months After Initial Diagnosis
Hide Description Disease free interval was expressed in months: (Date of diagnosis of metastatic disease - Date of initial diagnosis + 1) / 30.4375. Percentage of participants who were disease-free for at least 12 months were reported.
Time Frame From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population. Here number of participants analyzed were those who were available for this outcome measure.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 134 67
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
73.1
(65.1 to 79.9)
80.6
(69.6 to 88.3)
2.Primary Outcome
Title Percentage of Participants Who Were Disease-Free for at Least 24 Months After Initial Diagnosis
Hide Description Disease free interval was expressed in months: (Date of diagnosis of metastatic disease - Date of initial diagnosis + 1) / 30.4375. Percentage of participants who were disease-free for at least 24 months were reported.
Time Frame From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population. Here number of participants analyzed were those who were available for this outcome measure.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 134 67
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
68.7
(60.4 to 75.9)
56.7
(44.8 to 67.9)
3.Primary Outcome
Title Disease-Free Interval
Hide Description Disease free interval was expressed in months: (Date of diagnosis of metastatic disease - Date of initial diagnosis + 1) / 30.4375. Disease free interval was observed retrospectively and assessed at inclusion period or baseline (the time after the retrospective phase and at the start of prospective phase).
Time Frame From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population. Here number of participants analyzed were those who were available for this outcome measure.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 134 67
Median (Full Range)
Unit of Measure: months
51.0
(0 to 259)
28.0
(0 to 257)
4.Primary Outcome
Title Mean Age at the Time of Local or Metastatic Progression
Hide Description Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time Frame At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 135 67
Mean (Standard Deviation)
Unit of Measure: years
54.5  (11.8) 55.5  (10.4)
5.Primary Outcome
Title Percentage of Participants With Menopausal Status at the Time of Local or Metastatic Progression
Hide Description Menopausal status included premenopausal and menopausal. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time Frame At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population. Here number of participants analyzed were those who were available for the evaluation of menopausal status.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 117 59
Measure Type: Number
Unit of Measure: percentage of participants
Premenopausal 31.6 18.6
Menopausal 68.4 81.4
6.Primary Outcome
Title Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at the Time of Local or Metastatic Progression
Hide Description ECOG-PS measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on a 5 point scale: 0 equals (=) fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, but ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than [>] 50 percentage [%] of waking hours [h]), capable of all self care, but unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hours; 4= completely disabled, cannot carry on any selfcare, totally confined to bed or chair and 5=Dead. Only participants that reported in any of the specified scale was reported. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time Frame At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population. Here number of participants analyzed were those who were available for the evaluation of ECOG PS.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 122 53
Measure Type: Number
Unit of Measure: percentage of participants
0 46.7 54.7
1 43.4 37.7
2 9.0 7.5
3 0.8 0.0
7.Primary Outcome
Title Mean Body Weight at the Time of Local or Metastatic Progression
Hide Description Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time Frame At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population. Here number of participants analyzed were those who were available for the evaluation of body weight.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 131 66
Mean (Standard Deviation)
Unit of Measure: kilograms
66.8  (13.3) 66.2  (11.1)
8.Primary Outcome
Title Mean Height at the Time of Local or Metastatic Progression
Hide Description Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time Frame At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population. Here number of participants analyzed were those who were available for the evaluation of height.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 128 63
Mean (Standard Deviation)
Unit of Measure: centimeters
161.7  (5.9) 164.1  (5.6)
9.Primary Outcome
Title Mean Body Mass Index (BMI) at the Time of Local or Metastatic Progression
Hide Description BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time Frame At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population. Here number of participants analyzed were those who were available for the evaluation of BMI which was measured in kg/m^2.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 128 63
Mean (Standard Deviation)
Unit of Measure: kg/m^2
25.6  (4.9) 24.7  (4.2)
10.Primary Outcome
Title Percentage of Participants With Breast Cancer (BRCA) Mutation at the Time of Local or Metastatic Progression
Hide Description Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time Frame At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population. Here number of participants analyzed were those who were available for the evaluation of BRCA mutation.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 130 65
Measure Type: Number
Unit of Measure: percentage of participants
1.5 4.6
11.Primary Outcome
Title Percentage of Participants With Metastatic Disease at Identified Metastatic Sites at the Time of Local or Metastatic Progression
Hide Description Metastatic diseases were identified at bone, lung, liver, central nervous system, soft tissue, lymph nodes, skin, pleura and other sites. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time Frame At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 135 67
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Bone
63.7
(55.3 to 71.3)
46.3
(34.9 to 58.1)
Lung
34.1
(26.6 to 42.4)
29.9
(20.2 to 41.7)
Liver
35.6
(28.0 to 43.9)
17.9
(10.6 to 28.7)
Central nervous system
2.2
(0.5 to 6.4)
4.5
(0.9 to 12.5)
Soft tissue
10.4
(6.3 to 16.7)
14.9
(8.3 to 25.3)
Lymph nodes
11.9
(7.4 to 18.4)
28.4
(19.0 to 40.1)
Skin
5.2
(2.1 to 10.4)
4.5
(0.9 to 12.5)
Pleura
6.7
(3.1 to 12.3)
7.5
(2.5 to 16.6)
Other
8.1
(4.1 to 14.1)
7.5
(2.5 to 16.6)
12.Primary Outcome
Title Percentage of Participants Classified Based on Number of Metastatic Sites at the Time of Local or Metastatic Progression
Hide Description Percentage of participants that reported metastatic disease in less than or equal to (<=) 3 sites or greater than (>) 3 sites were assessed. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time Frame At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population. Here number of participants analyzed were those who were available for the evaluation of metastatic sites.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 134 66
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
<=3
56.7
(48.3 to 64.8)
71.2
(59.4 to 80.7)
>3
43.3
(35.2 to 51.7)
28.8
(19.3 to 40.6)
13.Primary Outcome
Title Percentage of Participants With Visceral Involvement at the Time of Local or Metastatic Progression
Hide Description Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time Frame At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 135 67
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
64.4
(56.1 to 72.0)
43.3
(32.1 to 55.2)
14.Primary Outcome
Title Percentage of Participants With Estrogen Receptors (ER) at the Time of Local or Metastatic Progression
Hide Description Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time Frame At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 90 43
Measure Type: Number
Unit of Measure: percentage of participants
ER+ 92.2 0
ER- 4.4 93.0
Unknown 3.3 7.0
15.Primary Outcome
Title Percentage of Participants With Progesterone Receptors (PR) at the Time of Local or Metastatic Progression
Hide Description Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time Frame At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 90 43
Measure Type: Number
Unit of Measure: percentage of participants
PR+ 64.4 0
PR- 31.1 93.0
Unknown 4.4 7.0
16.Primary Outcome
Title Percentage of Participants With Cross Results for Both ER and PR at the Time of Local or Metastatic Progression
Hide Description Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time Frame At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 86 40
Measure Type: Number
Unit of Measure: percentage of participants
ER+/PR+ 64.0 0
ER+/PR- 31.4 0
ER-/PR+ 3.5 0
ER-/PR- 1.2 100
17.Primary Outcome
Title Percentage of Participants With HR Status at the Time of Local or Metastatic Progression
Hide Description Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time Frame At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 87 40
Measure Type: Number
Unit of Measure: percentage of participants
HR+ 98.9 0
HR- 1.1 100
18.Primary Outcome
Title Percentage of Participants With Negative HER2 Status at the Time of Local or Metastatic Progression
Hide Description Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time Frame At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 91 40
Measure Type: Number
Unit of Measure: percentage of participants
100 100
19.Primary Outcome
Title Percentage of Participants With Mitotic Index (MI) at the Time of Local or Metastatic Progression
Hide Description MI is an indirect measure of cell proliferation that has been demonstrated to be a strong predictor of outcome for several human and canine cancers. Percentage of participants that reported a low, intermediate, high and unknown indices were included. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time Frame At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 79 40
Measure Type: Number
Unit of Measure: percentage of participants
Low 22.8 7.5
Intermediate 5.1 5.0
High 3.8 17.5
Unknown 68.4 70.0
20.Primary Outcome
Title Percentage of Participants With Ki67 (MiB1) at the Time of Local or Metastatic Progression
Hide Description The Ki67 (MiB1) a prognostic marker, is used to evaluate the proliferative activity of breast cancer. Percentage of participants with < or >=10% and unknown were reported. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time Frame At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 80 38
Measure Type: Number
Unit of Measure: percentage of participants
<10% 3.8 5.3
>=10% 11.3 13.2
Unknown 85.0 81.6
21.Primary Outcome
Title Percentage of Participants With Previous and Concurrent Disease at the Time of Local or Metastatic Progression
Hide Description Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time Frame At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 135 67
Measure Type: Number
Unit of Measure: percentage of participants
41.5 59.7
22.Primary Outcome
Title Percentage of Participants Who Received First-Line Endocrine Therapy at the Time of Local or Metastatic Progression
Hide Description Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time Frame At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.
Arm/Group Title Bevacizumab: HR+ Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 124
Measure Type: Number
Unit of Measure: percentage of participants
24.2
23.Secondary Outcome
Title Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR)
Hide Description Objective tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR was defined as the disappearance of all target and non-target lesions, and confirmed PR was defined as at least at 30% decrease in the sum of the longest diameters of target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. Inclusion (baseline) here was the time after the retrospective phase and at the start of prospective phase.
Time Frame From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months , assessed retrospectively at Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 131 59
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
CR
28.2
(21.2 to 36.5)
33.9
(23.1 to 46.6)
PR
58.0
(49.5 to 66.1)
45.8
(33.7 to 58.3)
24.Secondary Outcome
Title Percentage of Participants With Disease Progression or Death
Hide Description Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death"). PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment.
Time Frame From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months , assessed retrospectively at Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 135 67
Measure Type: Number
Unit of Measure: percentage of participants
79.3 80.6
25.Secondary Outcome
Title Progression-Free Survival
Hide Description Progression-free survival was defined as the time from first dose of bevacizumab to documented PD or death from any cause, whichever occurred first. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment. Inclusion (baseline) here was the time after the retrospective phase and at the start of prospective phase.
Time Frame From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months, assessed retrospectively at Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 135 67
Median (95% Confidence Interval)
Unit of Measure: months
25.3
(22.4 to 31.1)
21.2
(19.1 to 25.4)
26.Secondary Outcome
Title Time to Progression
Hide Description Objective tumor response was assessed using RECIST. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment. Participants who withdrew from the study early for insufficient therapeutic response without tumor assessment for PD were also included within the definition of PD. Time to progression was defined as the time from treatment start to PD. Participants who did not experience PD were censored from the last tumor assessment. Time to progression was estimated using Kaplan-Meier and expressed in months. Inclusion (baseline) here was the time after the retrospective phase and at the start of prospective phase.
Time Frame From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months, assessed retrospectively at Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 135 67
Median (95% Confidence Interval)
Unit of Measure: months
25.3
(22.4 to 31.8)
21.2
(19.1 to 25.4)
27.Secondary Outcome
Title Percentage of Participants With Death
Hide Description Overall survival (OS) was defined as the time between the first administration of bevacizumab and death from any cause and participants still alive at the end of the study were censored at the last consultation or last contact date.
Time Frame From the first administration of bevacizumab to death from any cause (up to a maximum of 60.8 months including retrospective and prospective treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 135 67
Measure Type: Number
Unit of Measure: percentage of participants
37.8 41.8
28.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time between the first administration of bevacizumab and death from any cause and participants still alive at the end of the study were censored at the last consultation or last contact date.
Time Frame From the first administration of bevacizumab to death from any cause (up to a maximum of 60.8 months including retrospective and prospective treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 135 67
Median (95% Confidence Interval)
Unit of Measure: months
57.2 [1] 
(50.7 to NA)
49.4 [2] 
(39.8 to NA)
[1]
The upper limit of confidence interval (CI) was not estimable because more than 50% of participants were censored.
[2]
The upper limit of CI was not estimable because more than 50% of participants were censored.
29.Secondary Outcome
Title Duration of Bevacizumab as First Line Treatment
Hide Description [Not Specified]
Time Frame From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 135 67
Median (Full Range)
Unit of Measure: months
21.2
(12.0 to 60.8)
18.6
(11.6 to 46.7)
30.Secondary Outcome
Title Percentage of Participants With Temporary Discontinuation
Hide Description [Not Specified]
Time Frame From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population. Here number of participants were those who were temporary discontinued.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 135 67
Measure Type: Number
Unit of Measure: percentage of participants
28.1 29.9
31.Secondary Outcome
Title Percentage of Participants With Reasons for Temporary Discontinuation
Hide Description [Not Specified]
Time Frame From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population. Here number of participants were those who were temporary discontinued.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 38 20
Measure Type: Number
Unit of Measure: percentage of participants
Adverse Event 34.2 35.0
Surgery 34.2 45.0
Participant's or Investigator's Decision 15.8 20.0
Unspecified 21.1 10.0
32.Secondary Outcome
Title Percentage of Participants With Definitive Discontinuation
Hide Description [Not Specified]
Time Frame From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population. Here number of participants were those who were temporary discontinued.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 135 67
Measure Type: Number
Unit of Measure: percentage of participants
75.6 88.1
33.Secondary Outcome
Title Percentage of Participants With Reasons for Definitive Discontinuation
Hide Description [Not Specified]
Time Frame From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population. Here number of participants were those who were definitive discontinued.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HR+ cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 102 59
Measure Type: Number
Unit of Measure: percentage of participants
Progressive disease 54.9 58.6
Adverse event 24.5 24.1
Participant's or Investigator's decision 16.7 15.5
Unspecified 3.9 1.7
34.Secondary Outcome
Title Percentage of Participants Who Maintained Bevacizumab Beyond the First Progressive Disease
Hide Description [Not Specified]
Time Frame From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population. Here number of participants were those who were available for this evaluation.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 104 53
Measure Type: Number
Unit of Measure: percentage of participants
25.0 17.0
35.Secondary Outcome
Title Percentage of Participants Who Received Induction Therapy in Combination With Bevacizumab
Hide Description [Not Specified]
Time Frame From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population.
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description:
Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
Overall Number of Participants Analyzed 135 67
Measure Type: Number
Unit of Measure: percentage of participants
99.3 98.5
Time Frame From inclusion (baseline) to 18 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Hide Arm/Group Description Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months. Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
All-Cause Mortality
Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Affected / at Risk (%) Affected / at Risk (%)
Total   10/150 (6.67%)   4/77 (5.19%) 
Blood and lymphatic system disorders     
Thrombocytopenia * 1  1/150 (0.67%)  0/77 (0.00%) 
Thrombotic microangiopathy * 1  0/150 (0.00%)  1/77 (1.30%) 
Cardiac disorders     
Coronary artery stenosis * 1  0/150 (0.00%)  1/77 (1.30%) 
Myocardial infarction * 1  0/150 (0.00%)  1/77 (1.30%) 
Gastrointestinal disorders     
Abdominal hernia * 1  0/150 (0.00%)  1/77 (1.30%) 
Intestinal obstruction * 1  1/150 (0.67%)  0/77 (0.00%) 
Subileus * 1  2/150 (1.33%)  0/77 (0.00%) 
General disorders     
General physical health deterioration * 1  3/150 (2.00%)  0/77 (0.00%) 
Death * 1  1/150 (0.67%)  0/77 (0.00%) 
Malaise * 1  1/150 (0.67%)  0/77 (0.00%) 
Hepatobiliary disorders     
Cholecystitis acute * 1  1/150 (0.67%)  0/77 (0.00%) 
Infections and infestations     
Lung infection * 1  1/150 (0.67%)  0/77 (0.00%) 
Pneumonia bacterial * 1  1/150 (0.67%)  0/77 (0.00%) 
Investigations     
Ejection fraction decreased * 1  0/150 (0.00%)  1/77 (1.30%) 
Musculoskeletal and connective tissue disorders     
Muscle disorder * 1  0/150 (0.00%)  1/77 (1.30%) 
Musculoskeletal pain * 1  1/150 (0.67%)  0/77 (0.00%) 
Nervous system disorders     
Neuropathy peripheral * 1  0/150 (0.00%)  1/77 (1.30%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea * 1  1/150 (0.67%)  0/77 (0.00%) 
Vascular disorders     
Embolism arterial * 1  1/150 (0.67%)  0/77 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bevacizumab: HR+ Breast Cancer Bevacizumab: TN Breast Cancer
Affected / at Risk (%) Affected / at Risk (%)
Total   7/150 (4.67%)   9/77 (11.69%) 
General disorders     
Asthenia * 1  4/150 (2.67%)  5/77 (6.49%) 
Renal and urinary disorders     
Proteinuria * 1  4/150 (2.67%)  5/77 (6.49%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01461044    
Other Study ID Numbers: ML27760
First Submitted: October 24, 2011
First Posted: October 27, 2011
Results First Submitted: October 22, 2015
Results First Posted: January 26, 2016
Last Update Posted: January 26, 2016