CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 202 enrolled
Drug / intervention
Atezolizumab +2 moredrug
Likely dose
Atezolizumab 1200 mgfrom 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/NCT02924883
NCT02924883Phase 2Completed

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase II Study of the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab and Taxane Based Therapy

Hoffmann-La Roche·interventional·Posted Oct 5, 2016·Updated Feb 17, 2021

In Brief

A Phase 2 clinical trial evaluating Atezolizumab, Trastuzumab emtansine, and 1 other intervention for Metastatic Breast Cancer. Completed, enrolled 202 participants across 68 sites in 9 countries.

Detailed Summary

This Phase II, double-blind, randomized, placebo-controlled multicenter study will investigate the efficacy and safety of trastuzumab emtansine in combination with atezolizumab or atezolizumab-placebo in participants with HER2-positive locally advanced or metastatic BC who have received prior trastuzumab and taxane based therapy, either alone or in combination, and/or who have progressed within 6 months after completing adjuvant therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, Germany, Italy, South Korea, Spain, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 5, 2016
Enrollment StartSep 26, 2016
Primary CompletionDec 11, 2017
Study CompletionFeb 6, 2020
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.7 years ago

Interventions

Atezolizumabdrug

Atezolizumab 1200 mg IV infusion

Trastuzumab emtansinedrug

Trastuzumab emtansine 3.6 mg/kg IV infusion

Placeboother

Placebo matched to atezolizumab