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Trial record 16 of 172 for:    pertuzumab

A Study of Perjeta (Pertuzumab) in Combination With Herceptin (Trastuzumab) in Participants With Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT01674062
Recruitment Status : Completed
First Posted : August 28, 2012
Results First Posted : September 11, 2015
Last Update Posted : August 22, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Pertuzumab
Drug: Trastuzumab
Enrollment 95
Recruitment Details  
Pre-assignment Details A total of 99 participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer were screened for Cohorts 1 and 2, of whom 66 were recruited. Following primary analysis of Cohorts 1 and 2, a total of 51 new participants were screened for Cohort 3, of whom 29 were recruited.
Arm/Group Title Pertuzumab + Trastuzumab (Cohorts 1 and 2) Pertuzumab +/- Trastuzumab (Cohort 3)
Hide Arm/Group Description Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via intravenous (IV) infusion as 2 milligrams per kilogram (mg/kg) once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 milligrams (mg) followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death. Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. Participants with documented disease progression could have trastuzumab added to the regimen, per the dosing schedule described for Cohorts 1 and 2, to receive dual-agent treatment until disease progression, intolerable toxicity, or death.
Period Title: Overall Study
Started 66 29
Completed 0 0
Not Completed 66 29
Reason Not Completed
Insufficient Therapeutic Response             56             26
Not Specified             8             1
Adverse Event             1             1
Death             0             1
Programming Error             1             0
Arm/Group Title Pertuzumab + Trastuzumab (Cohorts 1 and 2) Pertuzumab +/- Trastuzumab (Cohort 3) Total
Hide Arm/Group Description Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death. Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. Participants with documented disease progression could have trastuzumab added to the regimen, per the dosing schedule described for Cohorts 1 and 2, to receive dual-agent treatment until disease progression, intolerable toxicity, or death. Total of all reporting groups
Overall Number of Baseline Participants 66 29 95
Hide Baseline Analysis Population Description
All Treated Population: All randomized participants who received any amount of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 66 participants 29 participants 95 participants
54.9  (12.60) 53.0  (7.95) 54.3  (11.37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 29 participants 95 participants
Female
66
 100.0%
29
 100.0%
95
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Cohorts 1 and 2: Percentage of Participants With a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 During Dual-Agent Treatment
Hide Description Tumor response was assessed using RECIST version 1.0 to determine the objective response (OR) rate, or the percentage of participants with either confirmed CR or PR. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameter compared to Baseline. Response was to be confirmed a minimum of 4 weeks after the initial response was documented. The OR rate was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.
Time Frame Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population (Cohorts 1 and 2 only).
Arm/Group Title Pertuzumab + Trastuzumab (Cohorts 1 and 2)
Hide Arm/Group Description:
Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
Overall Number of Participants Analyzed 66
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: percentage of participants
24.2
(17.4 to 32.3)
2.Primary Outcome
Title Cohorts 1 and 2: Percentage of Participants With a Confirmed Best Overall Response of CR, PR, or Stable Disease (SD) According to RECIST Version 1.0 During Dual-Agent Treatment
Hide Description Tumor response was assessed using RECIST version 1.0 to determine the clinical benefit response (CBR) rate, or the percentage of participants with either confirmed CR or PR, or SD lasting at least 6 months. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to Baseline. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient (20%) increase to qualify for disease progression, in addition to no new target lesions. Response was to be confirmed a minimum of 4 weeks after the initial response was documented. The CBR rate was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.
Time Frame Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population (Cohorts 1 and 2 only).
Arm/Group Title Pertuzumab + Trastuzumab (Cohorts 1 and 2)
Hide Arm/Group Description:
Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
Overall Number of Participants Analyzed 66
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: percentage of participants
50.0
(41.5 to 58.5)
3.Secondary Outcome
Title Cohort 3: Percentage of Participants With a Confirmed Best Overall Response of CR or PR According to RECIST Version 1.0 During Single-Agent Treatment With Pertuzumab
Hide Description Tumor response was assessed using RECIST version 1.0 to determine the OR rate, or the percentage of participants with either confirmed CR or PR. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to Baseline. Response was to be confirmed a minimum of 4 weeks after the initial response was documented. The OR rate was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.
Time Frame Up to approximately 7.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population (Cohort 3 only).
Arm/Group Title Pertuzumab (Cohort 3)
Hide Arm/Group Description:
Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. The treatment regimen was maintained until disease progression, intolerable toxicity, death, and/or transition to dual-agent therapy with trastuzumab.
Overall Number of Participants Analyzed 29
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: percentage of participants
3.4
(0.4 to 12.8)
4.Secondary Outcome
Title Cohort 3: Percentage of Participants With a Confirmed Best Overall Response of CR, PR, or SD According to RECIST Version 1.0 During Single-Agent Treatment With Pertuzumab
Hide Description Tumor response was assessed using RECIST version 1.0 to determine the CBR rate, or the percentage of participants with either confirmed CR or PR, or SD lasting at least 6 months. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to Baseline. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient (20%) increase to qualify for disease progression, in addition to no new target lesions. Response was to be confirmed a minimum of 4 weeks after the initial response was documented. The CBR rate was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.
Time Frame Up to approximately 7.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population (Cohort 3 only).
Arm/Group Title Pertuzumab (Cohort 3)
Hide Arm/Group Description:
Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. The treatment regimen was maintained until disease progression, intolerable toxicity, death, and/or transition to dual-agent therapy with trastuzumab.
Overall Number of Participants Analyzed 29
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: percentage of participants
10.3
(3.9 to 21.6)
5.Secondary Outcome
Title Cohorts 1 and 2: Duration of Response According to RECIST Version 1.0
Hide Description Tumor response was assessed using RECIST version 1.0 to determine OR and CBR rates. Duration of OR was defined as time from initial response of CR or PR to time of disease progression or death. Duration of CBR was defined similarly as time from initial response of CR or PR, or SD lasting at least 6 months, to time of disease progression or death. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to Baseline. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient (20%) increase to qualify for disease progression, in addition to no new target lesions. Participants without progression or death following confirmed CR or PR were censored at the last tumor assessment. Duration of response was estimated using Kaplan-Meier analysis and expressed in weeks.
Time Frame Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population (Cohorts 1 and 2 only).
Arm/Group Title Pertuzumab + Trastuzumab (Cohorts 1 and 2)
Hide Arm/Group Description:
Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
Overall Number of Participants Analyzed 66
Median (Full Range)
Unit of Measure: weeks
Objective response
40.1
(12 to 413)
Clinical benefit response
50.14
(12.4 to 183.7)
6.Secondary Outcome
Title Cohorts 1 and 2: Time to Objective Response According to RECIST Version 1.0
Hide Description Tumor response was assessed using RECIST version 1.0 to determine the OR rate. Time to response was defined as the time from first dose to the time of initial response of CR or PR. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to Baseline. Participants with disease progression were censored at the time of progression, and those with neither disease progression nor OR were censored at the last tumor assessment. Time to response was estimated using Kaplan-Meier analysis and expressed in weeks.
Time Frame Up to approximately 21 months (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression; final analysis using February 2008 cutoff date)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population (Cohorts 1 and 2 only).
Arm/Group Title Pertuzumab + Trastuzumab (Cohorts 1 and 2)
Hide Arm/Group Description:
Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
Overall Number of Participants Analyzed 66
Median (Full Range)
Unit of Measure: weeks
11.14
(4.9 to 37.3)
7.Secondary Outcome
Title Cohorts 1 and 2: Percentage of Participants With Disease Progression According to RECIST Version 1.0
Hide Description Tumor response was assessed using RECIST version 1.0 to assess for disease progression, defined as at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions. The percentage of participants with disease progression was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.
Time Frame Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population (Cohorts 1 and 2 only).
Arm/Group Title Pertuzumab + Trastuzumab (Cohorts 1 and 2)
Hide Arm/Group Description:
Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
Overall Number of Participants Analyzed 66
Measure Type: Number
Unit of Measure: percentage of participants
93.9
8.Secondary Outcome
Title Cohorts 1 and 2: Time to Progression (TTP) According to RECIST Version 1.0
Hide Description Tumor response was assessed using RECIST version 1.0 to assess for disease progression, defined as at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions. TTP was defined as the time from first dose to the time of first documented disease progression. Participants who withdrew from the study without documented progression were censored at the last tumor assessment. TTP was estimated using Kaplan-Meier analysis and expressed in weeks.
Time Frame Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population (Cohorts 1 and 2 only).
Arm/Group Title Pertuzumab + Trastuzumab (Cohorts 1 and 2)
Hide Arm/Group Description:
Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
Overall Number of Participants Analyzed 66
Median (Full Range)
Unit of Measure: weeks
23.2
(4 to 244)
9.Secondary Outcome
Title Cohorts 1 and 2: Progression-Free Survival (PFS) According to RECIST Version 1.0
Hide Description Tumor response was assessed using RECIST version 1.0 to assess for disease progression, defined as at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions. PFS was defined as the time from first dose to the time of disease progression or death. Participants without progression or death were censored at the last tumor assessment. PFS was estimated using Kaplan-Meier analysis and expressed in weeks.
Time Frame Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population (Cohorts 1 and 2 only).
Arm/Group Title Pertuzumab + Trastuzumab (Cohorts 1 and 2)
Hide Arm/Group Description:
Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
Overall Number of Participants Analyzed 66
Median (80% Confidence Interval)
Unit of Measure: weeks
24.0
(18 to 34)
10.Secondary Outcome
Title Cohorts 1 and 2: Percentage of Participants Who Died
Hide Description Participants were followed for survival data during and after treatment for a maximum of 3 years after the last dose until death, withdrawal of consent, or loss to follow-up. The percentage of participants who died was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.
Time Frame Up to approximately 4.5 years (during treatment; then every 4 months until death, withdrawn consent, loss to follow-up, or 3 years after last dose; final analysis using November 2010 cutoff date)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population (Cohorts 1 and 2 only).
Arm/Group Title Pertuzumab + Trastuzumab (Cohorts 1 and 2)
Hide Arm/Group Description:
Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
Overall Number of Participants Analyzed 66
Measure Type: Number
Unit of Measure: percentage of participants
30.3
11.Secondary Outcome
Title Cohorts 1 and 2: Overall Survival (OS)
Hide Description Participants were followed for survival data during and after treatment for a maximum of 3 years after the last dose until death, withdrawal of consent, or loss to follow-up. OS was defined as the time from first dose to the time of death from any cause. Participants who did not experience death were censored at the last known alive date. OS was estimated using Kaplan-Meier and expressed in months.
Time Frame Up to approximately 4.5 years (during treatment; then every 4 months until death, withdrawn consent, loss to follow-up, or 3 years after last dose; final analysis using November 2010 cutoff date)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population (Cohorts 1 and 2 only).
Arm/Group Title Pertuzumab + Trastuzumab (Cohorts 1 and 2)
Hide Arm/Group Description:
Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
Overall Number of Participants Analyzed 66
Median (80% Confidence Interval)
Unit of Measure: months
38.5 [1] 
(32 to NA)
[1]
The value could not be calculated due to insufficient follow-up at the time the analysis was conducted.
Time Frame Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Adverse Event Reporting Description Analysis Population Description: All Treated Population.
 
Arm/Group Title Pertuzumab + Trastuzumab (Cohorts 1 and 2) Pertuzumab +/- Trastuzumab (Cohort 3)
Hide Arm/Group Description Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death. Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. Participants with documented disease progression could have trastuzumab added to the regimen, per the dosing schedule described for Cohorts 1 and 2, to receive dual-agent treatment until disease progression, intolerable toxicity, or death.
All-Cause Mortality
Pertuzumab + Trastuzumab (Cohorts 1 and 2) Pertuzumab +/- Trastuzumab (Cohort 3)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pertuzumab + Trastuzumab (Cohorts 1 and 2) Pertuzumab +/- Trastuzumab (Cohort 3)
Affected / at Risk (%) Affected / at Risk (%)
Total   12/66 (18.18%)   1/29 (3.45%) 
Cardiac disorders     
Palpitations * 1  1/66 (1.52%)  0/29 (0.00%) 
Gastrointestinal disorders     
Haematemesis * 1  1/66 (1.52%)  0/29 (0.00%) 
General disorders     
Performance status decreased * 1  1/66 (1.52%)  0/29 (0.00%) 
Hepatobiliary disorders     
Hepatic failure * 1  1/66 (1.52%)  0/29 (0.00%) 
Infections and infestations     
Cellulitis * 1  1/66 (1.52%)  0/29 (0.00%) 
Device related infection * 1  1/66 (1.52%)  0/29 (0.00%) 
Pneumonia * 1  1/66 (1.52%)  0/29 (0.00%) 
Pneumonia pneumococcal * 1  1/66 (1.52%)  0/29 (0.00%) 
Injury, poisoning and procedural complications     
Femur fracture * 1  0/66 (0.00%)  1/29 (3.45%) 
Metabolism and nutrition disorders     
Hypokalaemia * 1  1/66 (1.52%)  0/29 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  2/66 (3.03%)  0/29 (0.00%) 
Nervous system disorders     
Osmotic demyelination syndrome * 1  0/66 (0.00%)  1/29 (3.45%) 
Loss of consciousness * 1  1/66 (1.52%)  0/29 (0.00%) 
Dizziness * 1  1/66 (1.52%)  0/29 (0.00%) 
Psychiatric disorders     
Paranoia * 1  1/66 (1.52%)  0/29 (0.00%) 
Surgical and medical procedures     
Toe amputation * 1  1/66 (1.52%)  0/29 (0.00%) 
Vascular disorders     
Deep vein thrombosis * 1  1/66 (1.52%)  0/29 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (18.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pertuzumab + Trastuzumab (Cohorts 1 and 2) Pertuzumab +/- Trastuzumab (Cohort 3)
Affected / at Risk (%) Affected / at Risk (%)
Total   62/66 (93.94%)   28/29 (96.55%) 
Cardiac disorders     
Left ventricular dysfunction * 1  1/66 (1.52%)  2/29 (6.90%) 
Gastrointestinal disorders     
Diarrhoea * 1  42/66 (63.64%)  16/29 (55.17%) 
Nausea * 1  19/66 (28.79%)  12/29 (41.38%) 
Vomiting * 1  9/66 (13.64%)  10/29 (34.48%) 
Constipation * 1  9/66 (13.64%)  3/29 (10.34%) 
Dyspepsia * 1  8/66 (12.12%)  2/29 (6.90%) 
Abdominal pain upper * 1  5/66 (7.58%)  4/29 (13.79%) 
Abdominal distension * 1  3/66 (4.55%)  3/29 (10.34%) 
Abdominal pain * 1  4/66 (6.06%)  2/29 (6.90%) 
Stomatitis * 1  6/66 (9.09%)  0/29 (0.00%) 
Haemorroids * 1  4/66 (6.06%)  0/29 (0.00%) 
Toothache * 1  0/66 (0.00%)  2/29 (6.90%) 
General disorders     
Fatigue * 1  24/66 (36.36%)  8/29 (27.59%) 
Asthenia * 1  9/66 (13.64%)  6/29 (20.69%) 
Pyrexia * 1  6/66 (9.09%)  2/29 (6.90%) 
Chest pain * 1  5/66 (7.58%)  2/29 (6.90%) 
Chills * 1  4/66 (6.06%)  3/29 (10.34%) 
Mucosal inflammation * 1  6/66 (9.09%)  1/29 (3.45%) 
Influenza like illness * 1  3/66 (4.55%)  3/29 (10.34%) 
Oedema peripheral * 1  5/66 (7.58%)  0/29 (0.00%) 
Infections and infestations     
Nasopharyngitis * 1  8/66 (12.12%)  1/29 (3.45%) 
Upper respiratory tract infection * 1  3/66 (4.55%)  3/29 (10.34%) 
Localised infection * 1  5/66 (7.58%)  0/29 (0.00%) 
Rhinitis * 1  4/66 (6.06%)  1/29 (3.45%) 
Urinary tract infection * 1  4/66 (6.06%)  1/29 (3.45%) 
Investigations     
Weight decreased * 1  0/66 (0.00%)  4/29 (13.79%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  11/66 (16.67%)  6/29 (20.69%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  12/66 (18.18%)  4/29 (13.79%) 
Myalgia * 1  12/66 (18.18%)  0/29 (0.00%) 
Back pain * 1  4/66 (6.06%)  7/29 (24.14%) 
Muscle spasms * 1  10/66 (15.15%)  1/29 (3.45%) 
Pain in extremity * 1  6/66 (9.09%)  3/29 (10.34%) 
Musculoskeletal chest pain * 1  5/66 (7.58%)  3/29 (10.34%) 
Nervous system disorders     
Headache * 1  15/66 (22.73%)  4/29 (13.79%) 
Dizziness * 1  9/66 (13.64%)  3/29 (10.34%) 
Paraesthesia * 1  8/66 (12.12%)  0/29 (0.00%) 
Hypoaesthesia * 1  4/66 (6.06%)  0/29 (0.00%) 
Psychiatric disorders     
Insomnia * 1  4/66 (6.06%)  1/29 (3.45%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  12/66 (18.18%)  4/29 (13.79%) 
Dyspnoea * 1  6/66 (9.09%)  3/29 (10.34%) 
Oropharyngeal pain * 1  3/66 (4.55%)  3/29 (10.34%) 
Rhinorrhoea * 1  4/66 (6.06%)  0/29 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash * 1  18/66 (27.27%)  5/29 (17.24%) 
Pruritus * 1  9/66 (13.64%)  4/29 (13.79%) 
Nail disorder * 1  8/66 (12.12%)  2/29 (6.90%) 
Dry skin * 1  5/66 (7.58%)  1/29 (3.45%) 
Onychoclasis * 1  5/66 (7.58%)  0/29 (0.00%) 
Rash pruritic * 1  4/66 (6.06%)  0/29 (0.00%) 
Erythema * 1  1/66 (1.52%)  2/29 (6.90%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (18.1)
Although the study was designed as single-arm study, as reflected in the study title, an additional cohort was opened to evaluate the efficacy and safety of single-agent pertuzumab.
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-La Roche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01674062     History of Changes
Other Study ID Numbers: BO17929
2005-003493-19 ( EudraCT Number )
First Submitted: August 24, 2012
First Posted: August 28, 2012
Results First Submitted: August 11, 2015
Results First Posted: September 11, 2015
Last Update Posted: August 22, 2016