CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 562 enrolled
Drug / intervention
Trastuzumabdrug
Likely dose
Trastuzumab 6mg/kgfrom 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/NCT02162667
NCT02162667Phase 3Completed
CompareCT.gov

Phase 3 Efficacy and Safety Study of CT-P6 and Herceptin as Neoadjuvant and Adjuvant Treatment in Patients With Her2-positive Early Breast Cancer

Celltrion·interventional·Posted Jun 13, 2014·Updated Aug 3, 2022

In Brief

A Phase 3 clinical trial evaluating Trastuzumab for HER2-positive Carcinoma of Breast. Completed, enrolled 562 participants across 98 sites in 22 countries.

Detailed Summary

This study will determine whether CT-P6 and Herceptin are equivalent in patients with early-stage breast cancer undergoing neoadjuvant chemotherapy. Our hypothesis is that the pathologic complete response rate will be equivalent in patients treated with neoadjuvant CT-P6 or Herceptin. Patients will receive 8 cycles of neoadjuvant systemic therapy and up to 10 cycles of therapy in the adjuvant setting.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHER2-positive Carcinoma of Breast
CountriesArgentina, Belarus, Bosnia and Herzegovina, Chile, France, Georgia, Hungary, India, Italy, Japan, Latvia, Mexico, Peru, Philippines, Poland, Portugal, Romania, Russia, South Africa, Spain, Taiwan, Ukraine
CollaboratorsNippon Kayaku Co., Ltd.

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 13, 2014
Enrollment StartJun 1, 2014
Primary CompletionMay 26, 2016
Study CompletionOct 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 12.1 years ago

Interventions

Trastuzumabdrug

Trastuzumab 6mg/kg is ongoing to be administered for both arms after 8mg/kg loading dose.