Clinical Trial: NCT01358877
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
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Hoffmann-La Roche |
| Information Provided By: | Hoffmann-La Roche |
| Last Update Posted: | 2025-11-28 |
Study Overview
Brief 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).
Official Title
A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer
Conditions
Breast Cancer
Intervention / Treatment
- Drug: 5-Fluorouracil
- Drug: Carboplatin
- Drug: Cyclophosphamide
- Drug: Docetaxel
- Drug: Doxorubicin
- Drug: Epirubicin
- Drug: Paclitaxel
- Drug: Pertuzumab
- Drug: Placebo
- Drug: Trastuzumab
Other Study ID Numbers
- BO25126
- TOC4939G
- 2010-022902-41
- BIG 4-11
Start Date (Actual)
2011-11-08
Primary Completion Date (Actual)
2016-12-19
Study Completion Date (Actual)
2024-11-28
Enrollment (Actual)
4804
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Hoffmann-La Roche |
| Information Provided By: | Hoffmann-La Roche |
| Last Update Posted: | 2025-11-28 |
Study Overview
Brief 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).
Official Title
A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer
Conditions
Breast Cancer
Intervention / Treatment
- Drug: 5-Fluorouracil
- Drug: Carboplatin
- Drug: Cyclophosphamide
- Drug: Docetaxel
- Drug: Doxorubicin
- Drug: Epirubicin
- Drug: Paclitaxel
- Drug: Pertuzumab
- Drug: Placebo
- Drug: Trastuzumab
Other Study ID Numbers
- BO25126
- TOC4939G
- 2010-022902-41
- BIG 4-11
Start Date (Actual)
2011-11-08
Primary Completion Date (Actual)
2016-12-19
Study Completion Date (Actual)
2024-11-28
Enrollment (Actual)
4804
Study Type
Interventional
Phase
Phase 3