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Trial record 52 of 168 for:    pertuzumab

A Study of Pertuzumab in Combination With Trastuzumab Plus an Aromatase Inhibitor in Participants With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive and Hormone Receptor-Positive Advanced Breast Cancer (PERTAIN)

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ClinicalTrials.gov Identifier: NCT01491737
Recruitment Status : Active, not recruiting
First Posted : December 14, 2011
Results First Posted : June 7, 2017
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Pertuzumab
Drug: Trastuzumab
Drug: Aromatase Inhibitor
Drug: Induction Chemotherapy
Enrollment 258
Recruitment Details  
Pre-assignment Details A total of 258 participants were enrolled in the study from 17 February 2012. Results are presented here up to data cut-off date (17 March 2016).
Arm/Group Title Arm A: Pertuzumab and Trastuzumab Arm B: Trastuzumab
Hide Arm/Group Description Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling. Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
Period Title: Overall Study
Started 129 129
Completed 80 79
Not Completed 49 50
Reason Not Completed
Withdrawal of consent             13             13
Lost to Follow-up             1             6
Death             33             28
Reason not specified             2             3
Arm/Group Title Arm A: Pertuzumab and Trastuzumab Arm B: Trastuzumab Total
Hide Arm/Group Description Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling. Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling. Total of all reporting groups
Overall Number of Baseline Participants 129 129 258
Hide Baseline Analysis Population Description
Intent to treat (ITT) included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 129 participants 129 participants 258 participants
60.9  (10.85) 62.3  (11.54) 61.6  (11.20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants 129 participants 258 participants
Female
129
 100.0%
129
 100.0%
258
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Progression-Free Survival (PFS)
Hide Description PFS is defined as the time from randomization until the first radiographically documented progression of disease or death from any cause, whichever occurred first (either during study treatment or during follow-up). Progression of disease was evaluated according to the response evaluation criteria in solid tumors (RECIST) (version 1.1). Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (Note: the appearance of one or more new lesions is also considered progression). Participants with no PFS events were censored at the time of the last evaluable tumor assessment.
Time Frame Baseline to progressive disease or death (approximately, up to 49 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants.
Arm/Group Title Arm A: Pertuzumab and Trastuzumab Arm B: Trastuzumab
Hide Arm/Group Description:
Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
Overall Number of Participants Analyzed 129 129
Median (95% Confidence Interval)
Unit of Measure: months
18.89
(14.09 to 27.66)
15.80
(11.04 to 18.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Pertuzumab and Trastuzumab, Arm B: Trastuzumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0070
Comments Stratified log-rank test based upon Kaplan-Meier including induction chemotherapy and prior adjuvant therapy stratification factors from interactive response system (IXRS).
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.65
Confidence Interval (2-Sided) 95%
0.48 to 0.89
Estimation Comments Hazard ratio from stratified Cox proportional hazards model including stratification factors from IXRS.
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS is defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last study medication (pertuzumab, trastuzumab, AI or induction chemotherapy), and participants with no post-baseline information were censored at the date of randomization.
Time Frame From the date of randomization until first documented death (approximately, up to 49 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants.
Arm/Group Title Arm A: Pertuzumab and Trastuzumab Arm B: Trastuzumab
Hide Arm/Group Description:
Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
Overall Number of Participants Analyzed 129 129
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [1] 
(41.40 to NA)
[1]
Median OS was not reached.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Pertuzumab and Trastuzumab, Arm B: Trastuzumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5850
Comments Stratified log-rank test based upon Kaplan-Meier including induction chemotherapy and prior adjuvant therapy stratification factors from interactive response system (IXRS).
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.15
Confidence Interval (2-Sided) 95%
0.69 to 1.91
Estimation Comments Hazard ratio from stratified Cox proportional hazards model including stratification factors from IXRS.
3.Secondary Outcome
Title Duration of Response (DOR)
Hide Description DOR was defined as the period from the date of initial confirmed partial response (PR) or complete response (CR) until the date of progressive disease or death from any cause. According to RECIST version 1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm; PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants with no documented progression after CR or PR were censored at the last date at which they were known to have had the CR or PR, respectively.
Time Frame Baseline up to 49 months, approximately
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants. Here, number of participants analyzed are the participants who were responders and had measurable disease at baseline.
Arm/Group Title Arm A: Pertuzumab and Trastuzumab Arm B: Trastuzumab
Hide Arm/Group Description:
Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
Overall Number of Participants Analyzed 69 59
Median (95% Confidence Interval)
Unit of Measure: months
27.10 [1] 
(14.13 to NA)
15.11
(12.09 to 20.96)
[1]
Upper limit of confidence limit for duration of response was not reached.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Pertuzumab and Trastuzumab, Arm B: Trastuzumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0181
Comments Median and log-rank test from unstratified analysis based upon Kaplan-Meier approach. 95% CI for medians are determined using the log-log transformation.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.57
Confidence Interval (2-Sided) 95%
0.36 to 0.91
Estimation Comments Hazard ratio from stratified Cox proportional hazards model including stratification factors from IXRS.
4.Secondary Outcome
Title Time to Response (TTR)
Hide Description TTR was defined as the time from the date of randomization to the date of first CR or PR. According to RECIST version 1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm; PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. A censored time to response was calculated at the date of the last adequate tumor assessment as there was no date of confirmed response (CR or PR). If no tumor assessment is performed for the participant (or all post-baseline assessments are not evaluable or PD) the censoring day would be set to day 1 (date of randomization).
Time Frame Baseline up to 49 months, approximately
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants. Here, number of participants analyzed are the participants who were responders and had measurable disease at baseline.
Arm/Group Title Arm A: Pertuzumab and Trastuzumab Arm B: Trastuzumab
Hide Arm/Group Description:
Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
Overall Number of Participants Analyzed 109 106
Median (95% Confidence Interval)
Unit of Measure: months
2.53
(2.10 to 4.37)
3.91
(2.10 to 4.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Pertuzumab and Trastuzumab, Arm B: Trastuzumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5597
Comments Median and log-rank test from unstratified analysis based upon Kaplan-Meier approach. 95% CI for medians are determined using the log-log transformation.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.78 to 1.57
Estimation Comments Hazard ratio from stratified Cox proportional hazards model including stratification factors from IXRS.
5.Secondary Outcome
Title Objective Overall Response Rate (ORR)
Hide Description ORR was defined as participants with best (confirmed) overall response (BOR) of either CR or PR. ORR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until disease progression/recurrence or death. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm; PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference baseline sum diameters; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Participants needed to have two consecutive assessments of PR or CR to be a responder. Only participants with measurable disease at baseline were included in the analysis of BOR and who did not have any evaluable post-baseline assessments were classified as not evaluable.
Time Frame Baseline up to 49 months, approximately
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants. Here, number of participants analyzed are the participants who had measureable disease at baseline.
Arm/Group Title Arm A: Pertuzumab and Trastuzumab Arm B: Trastuzumab
Hide Arm/Group Description:
Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
Overall Number of Participants Analyzed 109 106
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
63.3
(53.5 to 72.3)
55.7
(45.7 to 65.3)
6.Secondary Outcome
Title Clinical Benefit Response (CBR)
Hide Description CBR is percentage of participants with best (confirmed) PR or CR or SD for at least 6 months. According to RECIST version 1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm; PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time Frame Baseline up to 49 months, approximately
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants. Here, number of participants analyzed is the participants with measurable disease at baseline.
Arm/Group Title Arm A: Pertuzumab and Trastuzumab Arm B: Trastuzumab
Hide Arm/Group Description:
Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
Overall Number of Participants Analyzed 109 106
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
68.8
(59.2 to 77.3)
67.0
(57.2 to 75.8)
7.Secondary Outcome
Title Change From Baseline in Health-Related Quality of Life as Determined by European Quality of Life 5-Dimension (EQ-5D) Visual Analog Scale (VAS) Scores
Hide Description EQ-5D VAS: participant rated questionnaire to assess health-related quality of life (QoL) in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time Frame Baseline, every 3 cycles (21-day cycle), and every 3 months after treatment discontinuation (up to 49 months, approximately)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants. Here, ‘n’ number of participants who were evaluated at specified time point.
Arm/Group Title Arm A: Pertuzumab and Trastuzumab Arm B: Trastuzumab
Hide Arm/Group Description:
Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
Overall Number of Participants Analyzed 129 129
Mean (Standard Deviation)
Unit of Measure: unit on a scale
Cycle 3 (n=87, 87) 3.3  (14.90) 1.9  (15.67)
Cycle 6 (n=82, 75) 3.5  (18.91) 0.5  (13.63)
Cycle 9 (n=68, 66) 5.3  (18.80) 2.1  (15.20)
Cycle 12 (n=58, 52) 10.7  (17.91) 4.0  (15.34)
Cycle 15 (n=54, 50) 9.1  (17.25) 1.4  (22.16)
Cycle 18 (n=47, 43) 7.5  (12.85) 3.5  (15.76)
Cycle 21 (n=44, 39) 5.8  (13.68) 3.5  (19.70)
Cycle 24 (n=39, 38) 6.2  (14.30) 3.2  (16.66)
Cycle 27 (n=35, 33) 7.5  (14.01) 2.6  (21.08)
Cycle 30 (n=32, 28) 8.4  (14.46) 3.3  (14.86)
Cycle 33 (n=30, 23) 4.8  (14.94) 3.6  (15.56)
Cycle 36 (n=25, 20) 5.0  (13.46) 5.3  (15.26)
Cycle 39 (n=21, 14) 6.0  (15.46) 10.4  (15.89)
Cycle 42 (16, 11) 3.4  (17.67) 11.4  (19.38)
Cycle 45 (n=13, 8) 8.5  (12.48) 9.3  (21.30)
Cycle 48 (n=9,4) 3.3  (8.66) -1.8  (2.36)
Cycle 51 (n=6, 4) 3.3  (11.69) 7.0  (12.36)
Cycle 54 (n=3, 2) 16.7  (17.56) 17.5  (17.68)
Cycle 57 (n=2, 0) 5.0  (7.07) NA [1]   (NA)
Cycle 60 (n=1, 0) -5.0 [2]   (NA) NA [1]   (NA)
[1]
No participant was evaluated at this time point.
[2]
Standard deviation was not estimable as only 1 participant was evaluated at this time point.
8.Secondary Outcome
Title Percentage of Participants With Any Adverse Event (AE)
Hide Description An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events.
Time Frame Up to 49 months approximately
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who had received at least 1 dose of any study medication assigned to treatment arms as treated.
Arm/Group Title Arm A: Pertuzumab and Trastuzumab Arm B: Trastuzumab
Hide Arm/Group Description:
Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
Overall Number of Participants Analyzed 127 124
Measure Type: Number
Unit of Measure: percentage of participants
96.1 98.4
Time Frame Up to cut-off date 17 March 2016 (approximate 49 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A: Pertuzumab and Trastuzumab Arm B: Trastuzumab
Hide Arm/Group Description Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling. Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
All-Cause Mortality
Arm A: Pertuzumab and Trastuzumab Arm B: Trastuzumab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm A: Pertuzumab and Trastuzumab Arm B: Trastuzumab
Affected / at Risk (%) Affected / at Risk (%)
Total   42/127 (33.07%)   24/124 (19.35%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  4/127 (3.15%)  2/124 (1.61%) 
Neutropenia  1  1/127 (0.79%)  1/124 (0.81%) 
Cardiac disorders     
Atrial fibrillation  1  2/127 (1.57%)  0/124 (0.00%) 
Cardiac failure  1  0/127 (0.00%)  1/124 (0.81%) 
Left ventricular dysfunction  1  3/127 (2.36%)  0/124 (0.00%) 
Mitral valve disease  1  1/127 (0.79%)  0/124 (0.00%) 
Myocardial ischaemia  1  1/127 (0.79%)  0/124 (0.00%) 
Sinus tachycardia  1  1/127 (0.79%)  0/124 (0.00%) 
Endocrine disorders     
Adrenal haemorrhage  1  1/127 (0.79%)  0/124 (0.00%) 
Gastrointestinal disorders     
Abdominal distension  1  1/127 (0.79%)  0/124 (0.00%) 
Abdominal pain  1  1/127 (0.79%)  1/124 (0.81%) 
Constipation  1  1/127 (0.79%)  0/124 (0.00%) 
Diarrhoea  1  0/127 (0.00%)  1/124 (0.81%) 
Vomiting  1  1/127 (0.79%)  1/124 (0.81%) 
General disorders     
Chest pain  1  0/127 (0.00%)  1/124 (0.81%) 
Pyrexia  1  0/127 (0.00%)  1/124 (0.81%) 
Hepatobiliary disorders     
Cholecystitis  1  1/127 (0.79%)  0/124 (0.00%) 
Immune system disorders     
Anaphylactic shock  1  1/127 (0.79%)  0/124 (0.00%) 
Contrast media allergy  1  1/127 (0.79%)  0/124 (0.00%) 
Hypersensitivity  1  3/127 (2.36%)  0/124 (0.00%) 
Infections and infestations     
Abscess  1  1/127 (0.79%)  0/124 (0.00%) 
Colonic abscess  1  0/127 (0.00%)  1/124 (0.81%) 
Device related infection  1  1/127 (0.79%)  2/124 (1.61%) 
Erysipelas  1  0/127 (0.00%)  1/124 (0.81%) 
Escherichia urinary tract infection  1  0/127 (0.00%)  1/124 (0.81%) 
Gastroenteritis  1  3/127 (2.36%)  0/124 (0.00%) 
Gastroenteritis viral  1  1/127 (0.79%)  0/124 (0.00%) 
Infection  1  1/127 (0.79%)  0/124 (0.00%) 
Mastitis  1  0/127 (0.00%)  1/124 (0.81%) 
Neutropenic sepsis  1  1/127 (0.79%)  1/124 (0.81%) 
Pneumonia  1  5/127 (3.94%)  1/124 (0.81%) 
Respiratory tract infection  1  1/127 (0.79%)  0/124 (0.00%) 
Sepsis  1  0/127 (0.00%)  1/124 (0.81%) 
Tooth infection  1  0/127 (0.00%)  1/124 (0.81%) 
Viral diarrhoea  1  1/127 (0.79%)  0/124 (0.00%) 
Injury, poisoning and procedural complications     
Femoral neck fracture  1  0/127 (0.00%)  1/124 (0.81%) 
Fracture  1  2/127 (1.57%)  0/124 (0.00%) 
Humerus fracture  1  1/127 (0.79%)  0/124 (0.00%) 
Post procedural haematoma  1  0/127 (0.00%)  1/124 (0.81%) 
Spinal fracture  1  1/127 (0.79%)  0/124 (0.00%) 
Investigations     
Ejection fraction decreased  1  1/127 (0.79%)  0/124 (0.00%) 
Metabolism and nutrition disorders     
Hyperglycaemia  1  1/127 (0.79%)  0/124 (0.00%) 
Hyperuricaemia  1  0/127 (0.00%)  1/124 (0.81%) 
Hyponatraemia  1  0/127 (0.00%)  1/124 (0.81%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/127 (0.79%)  0/124 (0.00%) 
Pain in extremity  1  0/127 (0.00%)  1/124 (0.81%) 
Pathological fracture  1  0/127 (0.00%)  1/124 (0.81%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma of colon  1  1/127 (0.79%)  0/124 (0.00%) 
Adenoid cystic carcinoma of salivary gland  1  0/127 (0.00%)  1/124 (0.81%) 
B-cell lymphoma  1  1/127 (0.79%)  0/124 (0.00%) 
Cancer pain  1  0/127 (0.00%)  1/124 (0.81%) 
Lung neoplasm  1  1/127 (0.79%)  0/124 (0.00%) 
Transitional cell carcinoma  1  0/127 (0.00%)  1/124 (0.81%) 
Nervous system disorders     
Hypoglycaemic coma  1  1/127 (0.79%)  0/124 (0.00%) 
Psychiatric disorders     
Depression  1  1/127 (0.79%)  0/124 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/127 (0.00%)  1/124 (0.81%) 
Chronic obstructive pulmonary disease  1  1/127 (0.79%)  0/124 (0.00%) 
Dyspnoea  1  1/127 (0.79%)  0/124 (0.00%) 
Pleural effusion  1  1/127 (0.79%)  0/124 (0.00%) 
Pneumonitis  1  1/127 (0.79%)  0/124 (0.00%) 
Pulmonary embolism  1  1/127 (0.79%)  1/124 (0.81%) 
Pulmonary oedema  1  1/127 (0.79%)  0/124 (0.00%) 
Surgical and medical procedures     
Colostomy closure  1  0/127 (0.00%)  1/124 (0.81%) 
Vascular disorders     
Haematoma  1  1/127 (0.79%)  0/124 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A: Pertuzumab and Trastuzumab Arm B: Trastuzumab
Affected / at Risk (%) Affected / at Risk (%)
Total   119/127 (93.70%)   115/124 (92.74%) 
Blood and lymphatic system disorders     
Anaemia  1  26/127 (20.47%)  18/124 (14.52%) 
Neutropenia  1  11/127 (8.66%)  12/124 (9.68%) 
Eye disorders     
Lacrimation increased  1  8/127 (6.30%)  7/124 (5.65%) 
Gastrointestinal disorders     
Abdominal pain  1  10/127 (7.87%)  12/124 (9.68%) 
Abdominal pain upper  1  8/127 (6.30%)  6/124 (4.84%) 
Constipation  1  16/127 (12.60%)  19/124 (15.32%) 
Diarrhoea  1  70/127 (55.12%)  44/124 (35.48%) 
Dyspepsia  1  8/127 (6.30%)  8/124 (6.45%) 
Nausea  1  41/127 (32.28%)  32/124 (25.81%) 
Stomatitis  1  17/127 (13.39%)  11/124 (8.87%) 
Vomiting  1  29/127 (22.83%)  21/124 (16.94%) 
General disorders     
Asthenia  1  39/127 (30.71%)  31/124 (25.00%) 
Chest Pain  1  9/127 (7.09%)  7/124 (5.65%) 
Chills  1  8/127 (6.30%)  7/124 (5.65%) 
Fatigue  1  21/127 (16.54%)  24/124 (19.35%) 
Influenza like illness  1  9/127 (7.09%)  6/124 (4.84%) 
Mucosal inflammation  1  14/127 (11.02%)  11/124 (8.87%) 
Oedema peripheral  1  31/127 (24.41%)  22/124 (17.74%) 
Pyrexia  1  15/127 (11.81%)  11/124 (8.87%) 
Infections and infestations     
Influenza  1  4/127 (3.15%)  7/124 (5.65%) 
Nasopharyngitis  1  11/127 (8.66%)  6/124 (4.84%) 
Upper respiratory tract infection  1  12/127 (9.45%)  13/124 (10.48%) 
Urinary tract infection  1  16/127 (12.60%)  14/124 (11.29%) 
Investigations     
Ejection fraction decreased  1  12/127 (9.45%)  6/124 (4.84%) 
Weight decreased  1  13/127 (10.24%)  10/124 (8.06%) 
Weight increased  1  9/127 (7.09%)  5/124 (4.03%) 
Metabolism and nutrition disorders     
Decreased appetite  1  20/127 (15.75%)  10/124 (8.06%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  37/127 (29.13%)  29/124 (23.39%) 
Back pain  1  20/127 (15.75%)  20/124 (16.13%) 
Bone pain  1  16/127 (12.60%)  9/124 (7.26%) 
Muscle spasms  1  12/127 (9.45%)  5/124 (4.03%) 
Musculoskeletal chest pain  1  9/127 (7.09%)  4/124 (3.23%) 
Musculoskeletal pain  1  8/127 (6.30%)  6/124 (4.84%) 
Myalgia  1  11/127 (8.66%)  9/124 (7.26%) 
Pain in extremity  1  21/127 (16.54%)  15/124 (12.10%) 
Nervous system disorders     
Dizziness  1  19/127 (14.96%)  11/124 (8.87%) 
Dysgeusia  1  9/127 (7.09%)  8/124 (6.45%) 
Headache  1  22/127 (17.32%)  14/124 (11.29%) 
Neuropathy peripheral  1  17/127 (13.39%)  17/124 (13.71%) 
Paraesthesia  1  13/127 (10.24%)  11/124 (8.87%) 
Peripheral sensory neuropathy  1  9/127 (7.09%)  9/124 (7.26%) 
Psychiatric disorders     
Anxiety  1  12/127 (9.45%)  5/124 (4.03%) 
Depression  1  9/127 (7.09%)  6/124 (4.84%) 
Insomnia  1  13/127 (10.24%)  17/124 (13.71%) 
Renal and urinary disorders     
Dysuria  1  9/127 (7.09%)  1/124 (0.81%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  22/127 (17.32%)  17/124 (13.71%) 
Dyspnoea  1  18/127 (14.17%)  12/124 (9.68%) 
Epistaxis  1  14/127 (11.02%)  12/124 (9.68%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  36/127 (28.35%)  40/124 (32.26%) 
Dry skin  1  7/127 (5.51%)  6/124 (4.84%) 
Nail disorder  1  9/127 (7.09%)  4/124 (3.23%) 
Pruritus  1  18/127 (14.17%)  12/124 (9.68%) 
Rash  1  22/127 (17.32%)  11/124 (8.87%) 
Vascular disorders     
Hot flush  1  8/127 (6.30%)  9/124 (7.26%) 
Hypertension  1  19/127 (14.96%)  23/124 (18.55%) 
Lymphoedema  1  7/127 (5.51%)  4/124 (3.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
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
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01491737     History of Changes
Other Study ID Numbers: MO27775
2011-002132-10 ( EudraCT Number )
First Submitted: December 6, 2011
First Posted: December 14, 2011
Results First Submitted: May 11, 2017
Results First Posted: June 7, 2017
Last Update Posted: April 30, 2019