A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer
NCT01358877 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4804
Last updated 2025-11-28
Summary
This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG).
Conditions
Interventions
- DRUG
-
5-Fluorouracil will be administered as per the schedule specified in the respective arm.
- DRUG
-
Carboplatin will be administered as per the schedule specified in the respective arm.
- DRUG
-
Cyclophosphamide will be administered as per the schedule specified in the respective arm.
- DRUG
-
Docetaxel will be administered as per the schedule specified in the respective arm.
- DRUG
-
Doxorubicin
Doxorubicin will be administered as per the schedule specified in the respective arm.
- DRUG
-
Epirubicin
Epirubicin will be administered as per the schedule specified in the respective arm.
- DRUG
-
Paclitaxel will be administered as per the schedule specified in the respective arm.
- DRUG
-
Pertuzumab will be administered as per the schedule specified in the respective arm.
- DRUG
-
Placebo will be administered as per the schedule specified in the respective arm.
- DRUG
-
Trastuzumab will be administered as per the schedule specified in the respective arm.
Sponsors & Collaborators
-
Genentech, Inc.
collaborator INDUSTRY -
Breast International Group
collaborator OTHER - lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-11-08
- Primary Completion
- 2016-12-19
- Completion
- 2024-11-28
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Austria
- Belgium
- Bulgaria
- Canada
- Chile
- China
- Colombia
- Croatia
- Czechia
- Denmark
- El Salvador
- France
- Germany
- Guatemala
- Hong Kong
- Hungary
- Ireland
- Israel
- Italy
- Japan
- Mexico
- Netherlands
- New Zealand
- Panama
- Peru
- Philippines
- Poland
- Romania
- Russia
- Slovenia
- South Africa
- South Korea
- Spain
- Sweden
- Switzerland
- Taiwan
- Thailand
- Ukraine
- United Kingdom
Study Locations
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