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 (APHINITY)
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 (APHINITY)
ClinicalTrials.gov ID: NCT01358877
Sponsor: Hoffmann-La Roche
Information provided by: Hoffmann-La Roche (Responsible Party)
Last Update Posted: 2024-09-19
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
Intervention / Treatment:
- Drug: 5-Fluorouracil
- Drug: Carboplatin
- Drug: Cyclophosphamide
- Drug: Docetaxel
- Drug: Doxorubicin
- Drug: Epirubicin
- Drug: Paclitaxel
- Drug: Pertuzumab
- Drug: Placebo
- Drug: Trastuzumab
| Category | Value |
|---|---|
| Study Start (Actual) |
2011-11-08
|
| Primary Completion (Actual) |
2016-12-19
|
| Study Completion (Estimated) |
2024-11-28
|
| Enrollment (Actual) | 4804 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
BO25126
TOC4939G (Other Identifier) (OTHER: Genentech) 2010-022902-41 (EudraCT Number) BIG 4-11 (Other Identifier) (OTHER: Breast International Group) |