CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 70 enrolled
Drug / intervention
Trastuzumab emtansinedrug
Likely dose
Trastuzumab emtansine 3.6 mg/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/NCT02658734
NCT02658734Phase 4Completed
CompareCT.gov

A Multicenter, Open-Label, Single-Arm, Phase IV Study of Trastuzumab Emtansine in Indian Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Treatment With Trastuzumab and a Taxane

Hoffmann-La Roche·interventional·Posted Jan 20, 2016·Updated Apr 2, 2021

In Brief

A Phase 4 clinical trial evaluating Trastuzumab emtansine for HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer. Completed, enrolled 70 participants across 13 sites.

Detailed Summary

This is a Phase IV, single-arm, multicenter, open-label clinical trial designed to assess the safety of trastuzumab emtansine in Indian patients with HER2-positive unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior treatment with trastuzumab and a taxane.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer
CountriesIndia
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 20, 2016
Enrollment StartNov 1, 2016
Primary CompletionDec 14, 2019
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 10.5 years ago

Interventions

Trastuzumab emtansinedrug

3.6 mg/kg intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle, repeated every 3 weeks