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Trial record 4 of 168 for:    pertuzumab

A Study of Pertuzumab in Participants With Metastatic 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: NCT02491892
Recruitment Status : Completed
First Posted : July 8, 2015
Results First Posted : August 25, 2015
Last Update Posted : August 25, 2015
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
Intervention Drug: Pertuzumab
Enrollment 79
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg
Hide Arm/Group Description Participants received a loading dose of 840 milligrams (mg) via intravenous (IV) infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression. Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
Period Title: Overall Study
Started 41 38
Treated 41 37 [1]
Completed 0 0
Not Completed 41 38
Reason Not Completed
Adverse Event             1             1
Death             1             1
Lack of Efficacy             37             36
Refused Treatment             1             0
Lost to Follow-up             1             0
[1]
One participant was randomized but died before receiving study medication.
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg Total
Hide Arm/Group Description Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression. Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression. Total of all reporting groups
Overall Number of Baseline Participants 41 37 78
Hide Baseline Analysis Population Description
Intent-to-Treat (ITT) Population: All randomized participants who received at least one dose of pertuzumab.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 37 participants 78 participants
55.3  (10.04) 53.5  (8.72) 54.4  (9.42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 37 participants 78 participants
Female
41
 100.0%
37
 100.0%
78
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants Achieving a Best Overall Response 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 lesions, and confirmed PR was defined as at least at 30 percent (%) 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. The percentage of participants achieving a best overall response of CR or PR was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.
Time Frame Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg
Hide Arm/Group Description:
Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
Overall Number of Participants Analyzed 41 37
Measure Type: Number
Unit of Measure: percentage of participants
4.9 0
2.Secondary Outcome
Title Time to Response Among Participants Achieving a Best Overall Response of Confirmed CR or PR
Hide Description Objective tumor response was assessed using RECIST. Confirmed CR was defined as the disappearance of all 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. Time to response was defined as the time from treatment start to first documented response (ie, CR or PR). Participants with stable disease (SD) were censored from the last tumor assessment, and those with progressive disease (PD) or death were assigned an artificial censoring time of 1000 days. Time to response was estimated using Kaplan-Meier and expressed in weeks.
Time Frame Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg
Hide Arm/Group Description:
Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
Overall Number of Participants Analyzed 41 37
Median (Full Range)
Unit of Measure: weeks
12.1
(6.1 to 18.0)
NA [1] 
(NA to NA)
[1]
Value could not be determined because no participants achieved CR or PR.
3.Secondary Outcome
Title Duration of Response Among Participants Achieving a Best Overall Response of Confirmed CR or PR
Hide Description Objective tumor response was assessed using RECIST. Confirmed CR was defined as the disappearance of all 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. Duration of response was defined as the time from first documented response (ie, CR or PR) to PD or death. Participants who did not experience PD or death were censored from the last tumor assessment. Duration of response was estimated using Kaplan-Meier and expressed in weeks.
Time Frame Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg
Hide Arm/Group Description:
Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
Overall Number of Participants Analyzed 41 37
Median (Full Range)
Unit of Measure: weeks
24.6
(18.1 to 31.0)
NA [1] 
(NA to NA)
[1]
Value could not be determined because no participants achieved CR or PR.
4.Secondary Outcome
Title Percentage of Participants Achieving a Best Overall Response of Confirmed CR
Hide Description Objective tumor response was assessed using RECIST. Confirmed CR was defined as the disappearance of all target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. The percentage of participants achieving a best overall response of CR was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.
Time Frame Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg
Hide Arm/Group Description:
Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
Overall Number of Participants Analyzed 41 37
Measure Type: Number
Unit of Measure: percentage of participants
0 0
5.Secondary Outcome
Title Duration of Response Among Participants Achieving a Best Overall Response of Confirmed CR
Hide Description Objective tumor response was assessed using RECIST. Confirmed CR was defined as the disappearance of all target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. Duration of response was defined as the time from first documented response (ie, CR) to PD or death. Participants who did not experience PD or death were to be censored from the last tumor assessment. Duration of response was to be estimated using Kaplan-Meier.
Time Frame Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg
Hide Arm/Group Description:
Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
Overall Number of Participants Analyzed 41 37
Median (Full Range)
Unit of Measure: weeks
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Value could not be determined because no participants achieved CR.
6.Secondary Outcome
Title Number of Participants Who Experienced PD or Death
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 Frame Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg
Hide Arm/Group Description:
Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
Overall Number of Participants Analyzed 41 37
Measure Type: Number
Unit of Measure: participants
38 36
7.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 or death. Participants who did not experience PD or death were censored from the last tumor assessment. Time to progression was estimated using Kaplan-Meier and expressed in weeks.
Time Frame Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg
Hide Arm/Group Description:
Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
Overall Number of Participants Analyzed 41 37
Median (Full Range)
Unit of Measure: weeks
6.1
(2.0 to 37.0)
6.1
(2.7 to 36.3)
8.Secondary Outcome
Title Number of Participants Who Experienced PD or Withdrew From the Study Early
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.
Time Frame Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg
Hide Arm/Group Description:
Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
Overall Number of Participants Analyzed 41 37
Measure Type: Number
Unit of Measure: participants
41 37
9.Secondary Outcome
Title Time to Treatment Failure
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. Time to treatment failure was defined as the time from treatment start to PD or early withdrawal from the study for death, toxicity, refusal/noncompliance, insufficient therapeutic response, or failure to return. Participants who did not experience PD or who did not withdraw from the study early were censored from the last tumor assessment. Time to treatment failure was estimated using Kaplan-Meier and expressed in weeks.
Time Frame Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg
Hide Arm/Group Description:
Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
Overall Number of Participants Analyzed 41 37
Median (Full Range)
Unit of Measure: weeks
6.3
(2.0 to 80.1)
6.0
(2.7 to 36.3)
10.Secondary Outcome
Title Percentage of Participants Who Died
Hide Description 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 2 years (from start of treatment until death)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: All randomized participants who received at least one dose of pertuzumab and had at least one post-baseline safety assessment.
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg
Hide Arm/Group Description:
Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
Overall Number of Participants Analyzed 41 37
Measure Type: Number
Unit of Measure: percentage of participants
46 32
11.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the time from treatment start to death. Participants who did not die during follow-up were to be censored from the last known alive date. Overall survival was to be estimated using Kaplan-Meier.
Time Frame Up to approximately 2 years (from start of treatment until death)
Hide Outcome Measure Data
Hide Analysis Population Description
Median survival was not reached because the study program was terminated early. Analysis of the incomplete data set was not performed because it could potentially produce skewed or statistically irrelevant data.
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg
Hide Arm/Group Description:
Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Percentage of Participants Achieving a Best Overall Response of SD
Hide Description Objective tumor response was assessed using RECIST. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for PD. The percentage of participants achieving a best overall response of SD was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.
Time Frame Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg
Hide Arm/Group Description:
Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
Overall Number of Participants Analyzed 41 37
Measure Type: Number
Unit of Measure: percentage of participants
43.9 37.8
13.Secondary Outcome
Title Apparent Half-Life (t1/2) of Pertuzumab
Hide Description Serum samples were obtained for pharmacokinetic (PK) assessment using a receptor-binding, enzyme-linked immunosorbent assay (ELISA). Pertuzumab concentrations at each collection point were used to determine the apparent t1/2 by non-compartmental analysis, defined as the time elapsed for pertuzumab concentrations to decrease by 50%. The derived value was averaged among all participants and expressed in days.
Time Frame Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants with missing PK data were excluded from the analysis.
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg
Hide Arm/Group Description:
Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
Overall Number of Participants Analyzed 38 36
Mean (Standard Deviation)
Unit of Measure: days
12.2  (3.9) 11.4  (4.1)
14.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) of Pertuzumab
Hide Description Serum samples were obtained for PK assessment using a receptor-binding ELISA. The maximum observed pertuzumab concentration across all collection points was documented. Cmax was averaged among all participants and expressed in micrograms per milliliter (mcg/mL).
Time Frame Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants with missing PK data were excluded from the analysis.
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg
Hide Arm/Group Description:
Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
Overall Number of Participants Analyzed 40 37
Mean (Standard Deviation)
Unit of Measure: mcg/mL
289  (107) 409  (159)
15.Secondary Outcome
Title Time to Maximum Plasma Concentration (Tmax) of Pertuzumab
Hide Description Serum samples were obtained for PK assessment using a receptor-binding ELISA. The time of maximum observed pertuzumab concentration across all collection points was documented. Tmax was averaged among all participants and expressed in days.
Time Frame Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants with missing PK data were excluded from the analysis.
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg
Hide Arm/Group Description:
Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
Overall Number of Participants Analyzed 40 37
Median (Full Range)
Unit of Measure: days
0.073
(0.052 to 7)
0.073
(0.059 to 0.122)
16.Secondary Outcome
Title Area Under the Concentration-Time Curve (AUC) of Pertuzumab
Hide Description Serum samples were obtained for PK assessment using a receptor-binding ELISA. Pertuzumab concentrations at each collection point were used to determine AUC to the last measurable observation (AUClast) and AUC extrapolated to infinity (AUCinf) by non-compartmental analysis. The derived values were averaged among all participants and expressed in days by micrograms per milliliter (days*mcg/mL).
Time Frame Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants with missing PK data were excluded from the analysis, and the number of participants analyzed (n) is presented here.
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg
Hide Arm/Group Description:
Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
Overall Number of Participants Analyzed 40 37
Mean (Standard Deviation)
Unit of Measure: days*mcg/mL
AUClast (n=40,37) 2517  (896) 3465  (1051)
AUCinf (n=38,36) 3598  (1402) 4750  (1527)
17.Secondary Outcome
Title Systemic Clearance (CL) of Pertuzumab
Hide Description Serum samples were obtained for PK assessment using a receptor-binding ELISA. Pertuzumab concentrations at each collection point were used to determine CL by non-compartmental analysis, defined as the rate at which pertuzumab was removed from the body. The derived value was averaged among all participants and expressed in milliliters per day (mL/day).
Time Frame Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants with missing PK data were excluded from the analysis.
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg
Hide Arm/Group Description:
Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
Overall Number of Participants Analyzed 38 36
Mean (Standard Deviation)
Unit of Measure: mL/day
270  (113) 247  (90)
18.Secondary Outcome
Title Volume of Distribution at Steady State (Vss) of Pertuzumab
Hide Description Serum samples were obtained for PK assessment using a receptor-binding ELISA. Pertuzumab concentrations at each collection point were used to determine the Vss by non-compartmental analysis, defined as the theoretical volume at which the total amount of pertuzumab would be uniformly distributed to produce the desired concentration. The derived value was averaged among all participants and expressed in milliliters (mL).
Time Frame Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants with missing PK data were excluded from the analysis.
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg
Hide Arm/Group Description:
Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
Overall Number of Participants Analyzed 38 36
Mean (Standard Deviation)
Unit of Measure: mL
4122  (1666) 3527  (1369)
19.Secondary Outcome
Title Mean Residence Time (MRT) of Pertuzumab
Hide Description Serum samples were obtained for PK assessment using a receptor-binding ELISA. Pertuzumab concentrations at each collection point were used to determine the MRT by non-compartmental analysis. The derived value was averaged among all participants and expressed in days.
Time Frame Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants with missing PK data were excluded from the analysis.
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg
Hide Arm/Group Description:
Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
Overall Number of Participants Analyzed 38 36
Mean (Standard Deviation)
Unit of Measure: days
16  (5) 15  (6)
20.Secondary Outcome
Title Number of Participants Experiencing a Drop in Left Ventricular Ejection Fraction (LVEF) to a Value of Less Than 50%
Hide Description Echocardiography was performed to determine LVEF, defined as the volume of blood pumped from the left ventricle as a percentage of end-diastolic volume. Theoretically, LVEF may range from 0 to 100%. The number of participants experiencing a drop in LVEF greater than or equal to (≥) 10 or 15 percentage points to a final LVEF of less than (<) 50% is reported here.
Time Frame Up to approximately 1 year (at Baseline; at the end of Cycles 2, 4, 8, 12, and 16; and up to 7 weeks following the last infusion)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg
Hide Arm/Group Description:
Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
Overall Number of Participants Analyzed 41 37
Measure Type: Number
Unit of Measure: participants
Drop ≥10 percentage points 3 5
Drop ≥15 percentage points 3 3
Time Frame Up to approximately 1 year (from start of treatment until up to 7 weeks following the last infusion)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pertuzumab 420 mg Pertuzumab 1050 mg
Hide Arm/Group Description Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression. Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
All-Cause Mortality
Pertuzumab 420 mg Pertuzumab 1050 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pertuzumab 420 mg Pertuzumab 1050 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   10/41 (24.39%)   8/37 (21.62%) 
Cardiac disorders     
Cardiac failure * 1  1/41 (2.44%)  0/37 (0.00%) 
Pericardial effusion * 1  1/41 (2.44%)  0/37 (0.00%) 
Gastrointestinal disorders     
Ascites * 1  1/41 (2.44%)  1/37 (2.70%) 
Diarrhoea * 1  0/41 (0.00%)  1/37 (2.70%) 
Dysphagia * 1  0/41 (0.00%)  1/37 (2.70%) 
Large intestinal obstruction * 1  0/41 (0.00%)  1/37 (2.70%) 
Infections and infestations     
Lung infection * 1  1/41 (2.44%)  0/37 (0.00%) 
Pneumonia * 1  1/41 (2.44%)  0/37 (0.00%) 
Sepsis * 1  1/41 (2.44%)  0/37 (0.00%) 
Investigations     
Ejection fraction decreased * 1  2/41 (4.88%)  0/37 (0.00%) 
Musculoskeletal and connective tissue disorders     
Neck pain * 1  1/41 (2.44%)  0/37 (0.00%) 
Nervous system disorders     
Headache * 1  1/41 (2.44%)  0/37 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion * 1  1/41 (2.44%)  1/37 (2.70%) 
Epistaxis * 1  0/41 (0.00%)  1/37 (2.70%) 
Skin and subcutaneous tissue disorders     
Palmar-plantar erythrodysaesthesia syndrome * 1  0/41 (0.00%)  1/37 (2.70%) 
Urticaria * 1  0/41 (0.00%)  1/37 (2.70%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (7.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pertuzumab 420 mg Pertuzumab 1050 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   36/41 (87.80%)   37/37 (100.00%) 
Blood and lymphatic system disorders     
Anaemia * 1  3/41 (7.32%)  4/37 (10.81%) 
Gastrointestinal disorders     
Diarrhoea * 1  24/41 (58.54%)  22/37 (59.46%) 
Nausea * 1  12/41 (29.27%)  13/37 (35.14%) 
Vomiting * 1  10/41 (24.39%)  8/37 (21.62%) 
Abdominal pain upper * 1  6/41 (14.63%)  6/37 (16.22%) 
Stomatitis * 1  4/41 (9.76%)  4/37 (10.81%) 
Dyspepsia * 1  3/41 (7.32%)  3/37 (8.11%) 
Abdominal pain * 1  4/41 (9.76%)  1/37 (2.70%) 
Oesophagitis * 1  1/41 (2.44%)  2/37 (5.41%) 
Dysphagia * 1  0/41 (0.00%)  2/37 (5.41%) 
Irritable bowel syndrome * 1  0/41 (0.00%)  2/37 (5.41%) 
General disorders     
Asthenia * 1  10/41 (24.39%)  9/37 (24.32%) 
Fatigue * 1  5/41 (12.20%)  5/37 (13.51%) 
Chest pain * 1  2/41 (4.88%)  5/37 (13.51%) 
Mucosal inflammation * 1  4/41 (9.76%)  2/37 (5.41%) 
Pyrexia * 1  3/41 (7.32%)  0/37 (0.00%) 
Infections and infestations     
Urinary tract infection * 1  2/41 (4.88%)  2/37 (5.41%) 
Herpes simplex * 1  1/41 (2.44%)  2/37 (5.41%) 
Ear infection * 1  0/41 (0.00%)  2/37 (5.41%) 
Nasopharyngitis * 1  0/41 (0.00%)  2/37 (5.41%) 
Investigations     
Ejection fraction decreased * 1  3/41 (7.32%)  3/37 (8.11%) 
Metabolism and nutrition disorders     
Anorexia * 1  4/41 (9.76%)  8/37 (21.62%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  3/41 (7.32%)  4/37 (10.81%) 
Back pain * 1  4/41 (9.76%)  3/37 (8.11%) 
Musculoskeletal pain * 1  2/41 (4.88%)  2/37 (5.41%) 
Chest wall pain * 1  0/41 (0.00%)  2/37 (5.41%) 
Nervous system disorders     
Headache * 1  7/41 (17.07%)  5/37 (13.51%) 
Paraesthesia * 1  3/41 (7.32%)  2/37 (5.41%) 
Dizziness * 1  1/41 (2.44%)  3/37 (8.11%) 
Dysgeusia * 1  0/41 (0.00%)  3/37 (8.11%) 
Psychiatric disorders     
Insomnia * 1  0/41 (0.00%)  3/37 (8.11%) 
Renal and urinary disorders     
Dysuria * 1  1/41 (2.44%)  2/37 (5.41%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  5/41 (12.20%)  5/37 (13.51%) 
Cough * 1  1/41 (2.44%)  4/37 (10.81%) 
Epistaxis * 1  2/41 (4.88%)  2/37 (5.41%) 
Pleural effusion * 1  2/41 (4.88%)  2/37 (5.41%) 
Skin and subcutaneous tissue disorders     
Rash * 1  6/41 (14.63%)  4/37 (10.81%) 
Dry skin * 1  4/41 (9.76%)  1/37 (2.70%) 
Pruritus * 1  2/41 (4.88%)  2/37 (5.41%) 
Erythema * 1  0/41 (0.00%)  2/37 (5.41%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (7.0)
Recruitment was halted within the planned study design. The study was designed to stop recruitment following the interim analysis if the response rate (CR or PR) was <1 of 23 participants per arm after all participants completed at least 2 cycles.
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-LaRoche
Phone: 800-821-8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02491892     History of Changes
Other Study ID Numbers: BO16934
First Submitted: June 11, 2015
First Posted: July 8, 2015
Results First Submitted: July 22, 2015
Results First Posted: August 25, 2015
Last Update Posted: August 25, 2015