CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,804 enrolled
Drug / intervention
5-Fluorouracil +9 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01358877
NCT01358877Phase 3Completed
CompareCT.gov

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

Hoffmann-La Roche·interventional·Posted May 24, 2011·Updated Nov 28, 2025

In Brief

A Phase 3 clinical trial evaluating 5-Fluorouracil, Carboplatin, and 8 other interventions for Breast Cancer. Completed, enrolled 4,804 participants across 546 sites in 42 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesArgentina, 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, United States
CollaboratorsGenentech, Inc., Breast International Group

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 24, 2011
Enrollment StartNov 8, 2011
Primary CompletionDec 19, 2016
Study CompletionNov 28, 2024
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 15.1 years ago

Interventions

5-Fluorouracildrug

5-Fluorouracil will be administered as per the schedule specified in the respective arm.

Carboplatindrug

Carboplatin will be administered as per the schedule specified in the respective arm.

Cyclophosphamidedrug

Cyclophosphamide will be administered as per the schedule specified in the respective arm.

Docetaxeldrug

Docetaxel will be administered as per the schedule specified in the respective arm.

Doxorubicindrug

Doxorubicin will be administered as per the schedule specified in the respective arm.

Epirubicindrug

Epirubicin will be administered as per the schedule specified in the respective arm.

Paclitaxeldrug

Paclitaxel will be administered as per the schedule specified in the respective arm.

Pertuzumabdrug

Pertuzumab will be administered as per the schedule specified in the respective arm.

Placebodrug

Placebo will be administered as per the schedule specified in the respective arm.

Trastuzumabdrug

Trastuzumab will be administered as per the schedule specified in the respective arm.