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Trial record 60 of 99 for:    FEC

A Study of Pertuzumab in Combination With Herceptin and Chemotherapy in Participants With HER2-Positive 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: NCT00976989
Recruitment Status : Completed
First Posted : September 15, 2009
Results First Posted : June 20, 2016
Last Update Posted : February 6, 2017
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: FEC
Drug: Docetaxel
Drug: TCH
Enrollment 225
Recruitment Details This study included 3 periods: Neoadjuvant (pre-operative) period and surgery, adjuvant (post-operative) period and post-treatment follow-up period.
Pre-assignment Details  
Arm/Group Title T+P Concomitant Anthracycline-based Chemotherapy T+P Sequential Anthracycline-based Chemotherapy T+P Concomitant Non-Anthracycline Chemotherapy
Hide Arm/Group Description 5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery. FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery. Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
Period Title: Overall Study
Started 73 75 77
Completed 60 63 60
Not Completed 13 12 17
Reason Not Completed
Violation of Selection Criteria at Entry             1             0             1
Death             5             7             10
Refused Treatment             4             3             5
Failure to Return             2             1             0
Recurrence of Disease             0             1             0
Other             1             0             1
Arm/Group Title T+P Concomitant Anthracycline-based Chemotherapy T+P Sequential Anthracycline-based Chemotherapy T+P Concomitant Non-Anthracycline Chemotherapy Total
Hide Arm/Group Description 5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery. FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery. Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery. Total of all reporting groups
Overall Number of Baseline Participants 73 75 77 225
Hide Baseline Analysis Population Description
Safety population included all participants who were randomized and received study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 73 participants 75 participants 77 participants 225 participants
49.6  (11.41) 50.5  (10.70) 50.6  (10.58) 50.6  (10.86)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants 75 participants 77 participants 225 participants
Female
73
 100.0%
75
 100.0%
77
 100.0%
225
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Safety: Percentage of Participants With Symptomatic Cardiac Events as Assessed by the Investigator
Hide Description Left ventricular systolic dysfunction (LVSD) as assessed by the Investigator, including Grade 3, 4 or 5 symptomatic LVSD with symptomatic cardiac events.
Time Frame From baseline up to approximately 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who were randomized and received study drug.
Arm/Group Title T+P Concomitant Anthracycline-based Chemotherapy T+P Sequential Anthracycline-based Chemotherapy T+P Concomitant Non-Anthracycline Chemotherapy
Hide Arm/Group Description:
5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
Overall Number of Participants Analyzed 72 75 76
Measure Type: Number
Unit of Measure: percentage of participants
0 2.7 1.3
2.Primary Outcome
Title Safety: Percentage of Participants With Left Ventricular Ejection Fraction (LVEF) Decline During Pre-operative (Neoadjuvant) Period
Hide Description Percentage of participants with LVEF measures decline of ≥ 10% from baseline and to a value of <50% during the pre-operative (neoadjuvant) period.
Time Frame From baseline up to approximately 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who were randomized and received study drug.
Arm/Group Title T+P Concomitant Anthracycline-based Chemotherapy T+P Sequential Anthracycline-based Chemotherapy T+P Concomitant Non-Anthracycline Chemotherapy
Hide Arm/Group Description:
5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
Overall Number of Participants Analyzed 72 75 76
Measure Type: Number
Unit of Measure: percentage of participants
5.6 5.3 3.9
3.Secondary Outcome
Title Efficacy: Percentage of Participants With Complete Pathological Response (pCR)
Hide Description pCR is defined as the absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. pCR is evaluated after 6 cycles of treatment and surgery or following withdrawal from the study whichever occurs sooner.
Time Frame At surgery, after 18 weeks (6 cycles) of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population included all participants who were randomized to treatment.
Arm/Group Title T+P Concomitant Anthracycline-based Chemotherapy T+P Sequential Anthracycline-based Chemotherapy T+P Concomitant Non-Anthracycline Chemotherapy
Hide Arm/Group Description:
5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
Overall Number of Participants Analyzed 73 75 77
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
61.6
(49.5 to 72.8)
57.3
(45.4 to 68.7)
66.2
(54.6 to 76.6)
4.Secondary Outcome
Title Efficacy: Clinical Response Rate
Hide Description Tumor response is defined as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) and is identified as per local practice. Clinical response rate is defined as the percentage of participants who achieve a response of CR or PR at any time pre-surgery. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by mammogram or magnetic resonance imaging (MRI) and clinical breast examination (CBE), CR is disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter of target lesions.
Time Frame During each 3-week cycle of 6 total cycles: up to 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to treatment.
Arm/Group Title T+P Concomitant Anthracycline-based Chemotherapy T+P Sequential Anthracycline-based Chemotherapy T+P Concomitant Non-Anthracycline Chemotherapy
Hide Arm/Group Description:
5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
Overall Number of Participants Analyzed 73 75 77
Measure Type: Number
Unit of Measure: percentage of participants
91.8 94.7 89.6
5.Secondary Outcome
Title Efficacy: Time to Clinical Response
Hide Description Time to clinical response is defined as the time from the date of first dose received to the first date of assessment of clinical response. Clinical response is defined as a response of CR or PR at any time pre-surgery. Per RECIST v1.0 for target lesions and assessed by mammogram or MRI and CBE, CR is disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter of target lesions.
Time Frame Up to 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to treatment.
Arm/Group Title T+P Concomitant Anthracycline-based Chemotherapy T+P Sequential Anthracycline-based Chemotherapy T+P Concomitant Non-Anthracycline Chemotherapy
Hide Arm/Group Description:
5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
Overall Number of Participants Analyzed 73 75 77
Median (95% Confidence Interval)
Unit of Measure: weeks
3.6
(3 to 6)
6.3
(6 to 7)
4.9
(4 to 6)
6.Secondary Outcome
Title Efficacy: Percentage of Participants Achieving Breast Conserving Surgery
Hide Description This is the percentage of participants who achieved breast conserving surgery out of the intent-to-treat population without inflammatory breast cancer, as these participants received mastectomy irrespective of their response to neoadjuvant (pre-operative) treatment.
Time Frame At approximately 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed represents the participants with T2-3 tumors for whom mastectomy was planned.
Arm/Group Title T+P Concomitant Anthracycline-based Chemotherapy T+P Sequential Anthracycline-based Chemotherapy T+P Concomitant Non-Anthracycline Chemotherapy
Hide Arm/Group Description:
5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
Overall Number of Participants Analyzed 46 36 37
Measure Type: Number
Unit of Measure: percentage of participants
21.7 16.7 27.0
7.Secondary Outcome
Title Efficacy: Percentage of Participants Without an Overall Survival (OS) Event
Hide Description Overall survival (OS) was defined as the time from randomization to the date of death from any cause. Participants who were alive or lost to follow-up were censored at the last known alive date. Participants with no post-baseline information were censored at the date of randomization plus one day.
Time Frame From baseline to end of study up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to treatment.
Arm/Group Title T+P Concomitant Anthracycline-based Chemotherapy T+P Sequential Anthracycline-based Chemotherapy T+P Concomitant Non-Anthracycline Chemotherapy
Hide Arm/Group Description:
5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
Overall Number of Participants Analyzed 73 75 77
Measure Type: Number
Unit of Measure: percentage of participants
93.2 90.7 87.0
8.Secondary Outcome
Title Efficacy: Percentage of Participants Without a Disease-Free Survival (DFS) Event
Hide Description The DFS was defined as the time from the first date of no disease (i.e., date of surgery) to the first documentation of progressive disease (PD) or death. PD was assessed using RECIST v1.0 and MRI and CBE. It was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions. Any evidence of contralateral disease in situ was not considered as PD. Participants who were withdrawn from the study without documented PD were censored at the date of the last assessment when the participant was known to be disease-free.
Time Frame From baseline to end of study up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to treatment. Number of participants analyzed is total number of participants evaluable during each period.
Arm/Group Title T+P Concomitant Anthracycline-based Chemotherapy T+P Sequential Anthracycline-based Chemotherapy T+P Concomitant Non-Anthracycline Chemotherapy
Hide Arm/Group Description:
5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
Overall Number of Participants Analyzed 69 67 72
Measure Type: Number
Unit of Measure: percentage of participants
85.5 88.1 84.7
9.Secondary Outcome
Title Efficacy: Percentage of Participants Without a Progression-Free Survival (PFS) Event
Hide Description Progression-free survival was defined as the time from the date of randomization to the first documentation of PD or death from any cause, whichever occurred first. PD was assessed using RECIST v1.0 and MRI and CBE. It was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions. Participants who were withdrawn from the study without documented PD were censored at the date of the last assessment when the participant was known to be free from PD. Participants without post-baseline assessments but known to be alive were censored at the time of randomization plus one day.
Time Frame From baseline to end of study up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to treatment.
Arm/Group Title T+P Concomitant Anthracycline-based Chemotherapy T+P Sequential Anthracycline-based Chemotherapy T+P Concomitant Non-Anthracycline Chemotherapy
Hide Arm/Group Description:
5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
Overall Number of Participants Analyzed 73 75 77
Measure Type: Number
Unit of Measure: percentage of participants
86.3 85.3 81.8
10.Secondary Outcome
Title Safety: Percentage of Participants With Cardiac Symptoms Associated With Symptomatic Left Ventricular Systolic Dysfunction (LVSD)
Hide Description Percentage of participants with signs or symptoms of cardiac events.
Time Frame From Baseline to end of Neoadjuvant Period (up to 18 weeks), Adjuvant Period (up to 1.5 years), Follow-up Period (up to 3.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all randomized participants who received treatment. Number of participants analyzed is total number of participants evaluable during each period.
Arm/Group Title T+P Concomitant Anthracycline-based Chemotherapy T+P Sequential Anthracycline-based Chemotherapy T+P Concomitant Non-Anthracycline Chemotherapy
Hide Arm/Group Description:
5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
Overall Number of Participants Analyzed 72 75 76
Measure Type: Number
Unit of Measure: percentage of participants
Neoadjuvant Period (n=72, 75, 76) 1.4 2.7 0
Adjuvant Period (n= 68, 65, 67) 0 0 1.5
Follow-up Period (n=70, 75, 74) 0 1.3 0
11.Secondary Outcome
Title Safety: Percentage of Participants With Asymptomatic Left Ventricular Ejection Fraction (LVEF) Events
Hide Description Percentage of participants with LVEF events without signs or symptoms of cardiac events.
Time Frame From baseline to end of Neoadjuvant Period (up to 18 weeks), Adjuvant Period (up to 1.5 years), Follow-up Period (up to 3.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all randomized participants who received treatment. Number of participants analyzed is total number of participants evaluable during each period.
Arm/Group Title T+P Concomitant Anthracycline-based Chemotherapy T+P Sequential Anthracycline-based Chemotherapy T+P Concomitant Non-Anthracycline Chemotherapy
Hide Arm/Group Description:
5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
Overall Number of Participants Analyzed 72 75 76
Measure Type: Number
Unit of Measure: percentage of participants
Neoadjuvant Period (n=72, 75, 76) 5.6 4.0 2.6
Adjuvant Period (n= 66, 64, 63) 3.0 0 4.8
Follow-up Period (n=21, 18, 23) 0 11.1 4.3
12.Secondary Outcome
Title Safety: Maximum Decrease in Left Ventricular Ejection Fraction (LVEF) Measures
Hide Description Maximum decrease in LVEF measures is the change from baseline at worst treatment value. LVEF is measured as percentage.
Time Frame From baseline up to approximately 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all randomized participants who received treatment. Number of participants analyzed is total number of participants evaluable.
Arm/Group Title T+P Concomitant Anthracycline-based Chemotherapy T+P Sequential Anthracycline-based Chemotherapy T+P Concomitant Non-Anthracycline Chemotherapy
Hide Arm/Group Description:
5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
Overall Number of Participants Analyzed 71 72 73
Mean (Standard Deviation)
Unit of Measure: percentage (ejection fraction)
-6.6  (5.15) -8.4  (5.66) -7.0  (6.48)
Time Frame Up to approximately 5 years
Adverse Event Reporting Description Safety population included all participants who were randomized and received study drug.
 
Arm/Group Title T+P Concomitant Anthracycline-based Chemotherapy T+P Sequential Anthracycline-based Chemotherapy T+P Concomitant Non-Anthracycline Chemotherapy
Hide Arm/Group Description 5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery. FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery. Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
All-Cause Mortality
T+P Concomitant Anthracycline-based Chemotherapy T+P Sequential Anthracycline-based Chemotherapy T+P Concomitant Non-Anthracycline Chemotherapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
T+P Concomitant Anthracycline-based Chemotherapy T+P Sequential Anthracycline-based Chemotherapy T+P Concomitant Non-Anthracycline Chemotherapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   23/72 (31.94%)   18/75 (24.00%)   31/76 (40.79%) 
Blood and lymphatic system disorders       
Febrile Neutropenia  1  10/72 (13.89%)  4/75 (5.33%)  11/76 (14.47%) 
Neutropenia  1  2/72 (2.78%)  3/75 (4.00%)  1/76 (1.32%) 
Leukopenia  1  2/72 (2.78%)  0/75 (0.00%)  0/76 (0.00%) 
Thrombocytopenia  1  0/72 (0.00%)  0/75 (0.00%)  2/76 (2.63%) 
Cardiac disorders       
Left ventricular dysfunction  1  1/72 (1.39%)  3/75 (4.00%)  1/76 (1.32%) 
Cardiovascular disorder  1  0/72 (0.00%)  0/75 (0.00%)  1/76 (1.32%) 
Conduction disorder  1  0/72 (0.00%)  0/75 (0.00%)  1/76 (1.32%) 
Gastrointestinal disorders       
Diarrhoea  1  1/72 (1.39%)  3/75 (4.00%)  4/76 (5.26%) 
Vomiting  1  0/72 (0.00%)  2/75 (2.67%)  0/76 (0.00%) 
Nausea  1  0/72 (0.00%)  1/75 (1.33%)  0/76 (0.00%) 
Small intestinal obstruction  1  0/72 (0.00%)  0/75 (0.00%)  1/76 (1.32%) 
General disorders       
Mucosal inflammation  1  0/72 (0.00%)  0/75 (0.00%)  2/76 (2.63%) 
Chest pain  1  0/72 (0.00%)  0/75 (0.00%)  1/76 (1.32%) 
General physical health deterioration  1  0/72 (0.00%)  0/75 (0.00%)  1/76 (1.32%) 
Pyrexia  1  1/72 (1.39%)  0/75 (0.00%)  0/76 (0.00%) 
Immune system disorders       
Drug hypersensitivity  1  1/72 (1.39%)  0/75 (0.00%)  2/76 (2.63%) 
Anaphylactic reaction  1  0/72 (0.00%)  0/75 (0.00%)  1/76 (1.32%) 
Infections and infestations       
Pneumonia  1  2/72 (2.78%)  0/75 (0.00%)  2/76 (2.63%) 
Neutropenic infection  1  0/72 (0.00%)  2/75 (2.67%)  1/76 (1.32%) 
Wound infection  1  0/72 (0.00%)  1/75 (1.33%)  1/76 (1.32%) 
Anal abscess  1  1/72 (1.39%)  0/75 (0.00%)  0/76 (0.00%) 
Appendicitis  1  0/72 (0.00%)  1/75 (1.33%)  0/76 (0.00%) 
Catheter site infection  1  0/72 (0.00%)  0/75 (0.00%)  1/76 (1.32%) 
Clostridium difficile colitis  1  0/72 (0.00%)  0/75 (0.00%)  1/76 (1.32%) 
Clostridium difficile infection  1  1/72 (1.39%)  0/75 (0.00%)  0/76 (0.00%) 
Cystitis  1  1/72 (1.39%)  0/75 (0.00%)  0/76 (0.00%) 
Device related infection  1  0/72 (0.00%)  1/75 (1.33%)  0/76 (0.00%) 
Device related sepsis  1  0/72 (0.00%)  1/75 (1.33%)  0/76 (0.00%) 
Gastroenteritis  1  0/72 (0.00%)  1/75 (1.33%)  0/76 (0.00%) 
Infection  1  0/72 (0.00%)  1/75 (1.33%)  0/76 (0.00%) 
Lung Abscess  1  1/72 (1.39%)  0/75 (0.00%)  0/76 (0.00%) 
Neutropenic sepsis  1  0/72 (0.00%)  0/75 (0.00%)  1/76 (1.32%) 
Pseudomembranous colitis  1  1/72 (1.39%)  0/75 (0.00%)  0/76 (0.00%) 
Pyelonephritis  1  0/72 (0.00%)  0/75 (0.00%)  1/76 (1.32%) 
Urinary tract infection  1  1/72 (1.39%)  0/75 (0.00%)  0/76 (0.00%) 
Injury, poisoning and procedural complications       
Post procedural haematoma  1  0/72 (0.00%)  0/75 (0.00%)  1/76 (1.32%) 
Seroma  1  0/72 (0.00%)  1/75 (1.33%)  0/76 (0.00%) 
Metabolism and nutrition disorders       
Dehydration  1  0/72 (0.00%)  1/75 (1.33%)  1/76 (1.32%) 
Electrolyte imbalance  1  0/72 (0.00%)  0/75 (0.00%)  1/76 (1.32%) 
Hypokalaemia  1  0/72 (0.00%)  0/75 (0.00%)  1/76 (1.32%) 
Hypomagnesaemia  1  0/72 (0.00%)  0/75 (0.00%)  1/76 (1.32%) 
Hyponatraemia  1  0/72 (0.00%)  1/75 (1.33%)  0/76 (0.00%) 
Musculoskeletal and connective tissue disorders       
Musculoskeletal pain  1  1/72 (1.39%)  0/75 (0.00%)  0/76 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Metastatic neoplasm  1  1/72 (1.39%)  0/75 (0.00%)  0/76 (0.00%) 
Nervous system disorders       
Cerebrovascular accident  1  0/72 (0.00%)  0/75 (0.00%)  1/76 (1.32%) 
Epilepsy  1  0/72 (0.00%)  0/75 (0.00%)  1/76 (1.32%) 
Psychiatric disorders       
Panic attack  1  0/72 (0.00%)  1/75 (1.33%)  0/76 (0.00%) 
Reproductive system and breast disorders       
Breast mass  1  0/72 (0.00%)  1/75 (1.33%)  0/76 (0.00%) 
Breast necrosis  1  1/72 (1.39%)  0/75 (0.00%)  0/76 (0.00%) 
Ovarian cyst  1  0/72 (0.00%)  1/75 (1.33%)  0/76 (0.00%) 
Vaginal haemorrhage  1  1/72 (1.39%)  0/75 (0.00%)  0/76 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Epistaxis  1  0/72 (0.00%)  0/75 (0.00%)  1/76 (1.32%) 
Pneumonitis  1  0/72 (0.00%)  1/75 (1.33%)  0/76 (0.00%) 
Pulmonary embolism  1  1/72 (1.39%)  0/75 (0.00%)  0/76 (0.00%) 
Indicates events were collected by 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%
T+P Concomitant Anthracycline-based Chemotherapy T+P Sequential Anthracycline-based Chemotherapy T+P Concomitant Non-Anthracycline Chemotherapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   72/72 (100.00%)   73/75 (97.33%)   76/76 (100.00%) 
Blood and lymphatic system disorders       
Neutropenia  1  36/72 (50.00%)  33/75 (44.00%)  37/76 (48.68%) 
Anaemia  1  14/72 (19.44%)  8/75 (10.67%)  29/76 (38.16%) 
Leukopenia  1  16/72 (22.22%)  12/75 (16.00%)  13/76 (17.11%) 
Thrombocytopenia  1  5/72 (6.94%)  1/75 (1.33%)  23/76 (30.26%) 
Febrile neutropenia  1  4/72 (5.56%)  3/75 (4.00%)  2/76 (2.63%) 
Cardiac disorders       
Left ventricular dysfunction  1  7/72 (9.72%)  8/75 (10.67%)  7/76 (9.21%) 
Palpitations  1  3/72 (4.17%)  1/75 (1.33%)  4/76 (5.26%) 
Eye disorders       
Lacrimation increased  1  9/72 (12.50%)  4/75 (5.33%)  6/76 (7.89%) 
Eyelid oedema  1  1/72 (1.39%)  1/75 (1.33%)  4/76 (5.26%) 
Gastrointestinal disorders       
Diarrhoea  1  46/72 (63.89%)  44/75 (58.67%)  55/76 (72.37%) 
Nausea  1  38/72 (52.78%)  41/75 (54.67%)  34/76 (44.74%) 
Vomiting  1  29/72 (40.28%)  27/75 (36.00%)  30/76 (39.47%) 
Dyspepsia  1  19/72 (26.39%)  9/75 (12.00%)  17/76 (22.37%) 
Constipation  1  14/72 (19.44%)  18/75 (24.00%)  13/76 (17.11%) 
Stomatitis  1  10/72 (13.89%)  13/75 (17.33%)  9/76 (11.84%) 
Abdominal pain upper  1  7/72 (9.72%)  6/75 (8.00%)  5/76 (6.58%) 
Abdominal pain  1  3/72 (4.17%)  7/75 (9.33%)  6/76 (7.89%) 
Dry mouth  1  4/72 (5.56%)  2/75 (2.67%)  8/76 (10.53%) 
Haemorrhoids  1  5/72 (6.94%)  1/75 (1.33%)  4/76 (5.26%) 
Abdominal distension  1  2/72 (2.78%)  2/75 (2.67%)  4/76 (5.26%) 
Oral pain  1  1/72 (1.39%)  4/75 (5.33%)  2/76 (2.63%) 
General disorders       
Fatigue  1  30/72 (41.67%)  28/75 (37.33%)  33/76 (43.42%) 
Mucosal inflammation  1  17/72 (23.61%)  15/75 (20.00%)  12/76 (15.79%) 
Pyrexia  1  11/72 (15.28%)  9/75 (12.00%)  15/76 (19.74%) 
Asthenia  1  9/72 (12.50%)  14/75 (18.67%)  10/76 (13.16%) 
Oedema peripheral  1  10/72 (13.89%)  5/75 (6.67%)  9/76 (11.84%) 
Pain  1  3/72 (4.17%)  7/75 (9.33%)  4/76 (5.26%) 
Chills  1  4/72 (5.56%)  1/75 (1.33%)  7/76 (9.21%) 
Chest pain  1  2/72 (2.78%)  4/75 (5.33%)  5/76 (6.58%) 
Influenza like illness  1  2/72 (2.78%)  5/75 (6.67%)  2/76 (2.63%) 
Oedema  1  1/72 (1.39%)  3/75 (4.00%)  5/76 (6.58%) 
Malaise  1  0/72 (0.00%)  2/75 (2.67%)  5/76 (6.58%) 
Axillary pain  1  0/72 (0.00%)  0/75 (0.00%)  5/76 (6.58%) 
Chest discomfort  1  4/72 (5.56%)  3/75 (4.00%)  3/76 (3.95%) 
Immune system disorders       
Drug hypersensitivity  1  6/72 (8.33%)  2/75 (2.67%)  7/76 (9.21%) 
Infections and infestations       
Nasopharyngitis  1  6/72 (8.33%)  9/75 (12.00%)  9/76 (11.84%) 
Upper respiratory tract infection  1  7/72 (9.72%)  10/75 (13.33%)  3/76 (3.95%) 
Urinary tract infection  1  5/72 (6.94%)  7/75 (9.33%)  7/76 (9.21%) 
Rhinitis  1  6/72 (8.33%)  1/75 (1.33%)  4/76 (5.26%) 
Cystitis  1  0/72 (0.00%)  4/75 (5.33%)  6/76 (7.89%) 
Conjunctivitis  1  3/72 (4.17%)  2/75 (2.67%)  4/76 (5.26%) 
Influenza  1  5/72 (6.94%)  4/75 (5.33%)  2/76 (2.63%) 
Injury, poisoning and procedural complications       
Radiation skin injury  1  11/72 (15.28%)  14/75 (18.67%)  7/76 (9.21%) 
Seroma  1  4/72 (5.56%)  4/75 (5.33%)  1/76 (1.32%) 
Investigations       
Haemoglobin decreased  1  6/72 (8.33%)  4/75 (5.33%)  7/76 (9.21%) 
Alanine aminotransferase increased  1  5/72 (6.94%)  3/75 (4.00%)  8/76 (10.53%) 
Aspartate aminotransferase increased  1  4/72 (5.56%)  3/75 (4.00%)  5/76 (6.58%) 
Weight decreased  1  3/72 (4.17%)  4/75 (5.33%)  5/76 (6.58%) 
Metabolism and nutrition disorders       
Decreased appetite  1  15/72 (20.83%)  8/75 (10.67%)  16/76 (21.05%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  18/72 (25.00%)  18/75 (24.00%)  11/76 (14.47%) 
Myalgia  1  14/72 (19.44%)  16/75 (21.33%)  8/76 (10.53%) 
Back pain  1  11/72 (15.28%)  9/75 (12.00%)  7/76 (9.21%) 
Musculoskeletal pain  1  11/72 (15.28%)  8/75 (10.67%)  5/76 (6.58%) 
Pain in extremity  1  7/72 (9.72%)  7/75 (9.33%)  7/76 (9.21%) 
Muscle spasms  1  4/72 (5.56%)  4/75 (5.33%)  6/76 (7.89%) 
Musculoskeletal chest pain  1  5/72 (6.94%)  3/75 (4.00%)  5/76 (6.58%) 
Bone pain  1  4/72 (5.56%)  4/75 (5.33%)  2/76 (2.63%) 
Nervous system disorders       
Headache  1  20/72 (27.78%)  15/75 (20.00%)  16/76 (21.05%) 
Dysgeusia  1  8/72 (11.11%)  10/75 (13.33%)  16/76 (21.05%) 
Dizziness  1  7/72 (9.72%)  9/75 (12.00%)  15/76 (19.74%) 
Neuropathy peripheral  1  5/72 (6.94%)  4/75 (5.33%)  8/76 (10.53%) 
Peripheral sensory neuropathy  1  4/72 (5.56%)  8/75 (10.67%)  5/76 (6.58%) 
Paraesthesia  1  3/72 (4.17%)  4/75 (5.33%)  9/76 (11.84%) 
Polyneuropathy  1  4/72 (5.56%)  1/75 (1.33%)  4/76 (5.26%) 
Psychiatric disorders       
Insomnia  1  12/72 (16.67%)  13/75 (17.33%)  17/76 (22.37%) 
Depression  1  3/72 (4.17%)  3/75 (4.00%)  4/76 (5.26%) 
Anxiety  1  1/72 (1.39%)  4/75 (5.33%)  4/76 (5.26%) 
Renal and urinary disorders       
Dysuria  1  2/72 (2.78%)  0/75 (0.00%)  7/76 (9.21%) 
Reproductive system and breast disorders       
Breast pain  1  2/72 (2.78%)  3/75 (4.00%)  6/76 (7.89%) 
Vulvovaginal dryness  1  0/72 (0.00%)  1/75 (1.33%)  4/76 (5.26%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  13/72 (18.06%)  8/75 (10.67%)  10/76 (13.16%) 
Epistaxis  1  8/72 (11.11%)  10/75 (13.33%)  11/76 (14.47%) 
Cough  1  10/72 (13.89%)  8/75 (10.67%)  10/76 (13.16%) 
Oropharyngeal pain  1  7/72 (9.72%)  6/75 (8.00%)  9/76 (11.84%) 
Rhinorrhoea  1  3/72 (4.17%)  5/75 (6.67%)  7/76 (9.21%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  35/72 (48.61%)  39/75 (52.00%)  42/76 (55.26%) 
Rash  1  17/72 (23.61%)  8/75 (10.67%)  20/76 (26.32%) 
Nail disorder  1  9/72 (12.50%)  8/75 (10.67%)  10/76 (13.16%) 
Erythema  1  10/72 (13.89%)  5/75 (6.67%)  11/76 (14.47%) 
Dry skin  1  5/72 (6.94%)  7/75 (9.33%)  8/76 (10.53%) 
Palmar -plantar erythrodysaesthesia syndrome  1  5/72 (6.94%)  9/75 (12.00%)  6/76 (7.89%) 
Pruritus  1  3/72 (4.17%)  7/75 (9.33%)  4/76 (5.26%) 
Skin reaction  1  2/72 (2.78%)  5/75 (6.67%)  3/76 (3.95%) 
Dermatitis  1  1/72 (1.39%)  5/75 (6.67%)  0/76 (0.00%) 
Hyperhidrosis  1  1/72 (1.39%)  0/75 (0.00%)  5/76 (6.58%) 
Night sweats  1  1/72 (1.39%)  0/75 (0.00%)  5/76 (6.58%) 
Skin hyperpigmentation  1  2/72 (2.78%)  4/75 (5.33%)  0/76 (0.00%) 
Skin exfoliation  1  0/72 (0.00%)  4/75 (5.33%)  0/76 (0.00%) 
Vascular disorders       
Hot Flush  1  11/72 (15.28%)  9/75 (12.00%)  10/76 (13.16%) 
Hypertension  1  5/72 (6.94%)  2/75 (2.67%)  5/76 (6.58%) 
Lymphoedema  1  2/72 (2.78%)  5/75 (6.67%)  4/76 (5.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
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: NCT00976989     History of Changes
Other Study ID Numbers: BO22280
2009-012019-17 ( EudraCT Number )
First Submitted: September 14, 2009
First Posted: September 15, 2009
Results First Submitted: March 28, 2016
Results First Posted: June 20, 2016
Last Update Posted: February 6, 2017