CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
T-DM1 +5 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/NCT02073487
NCT02073487Phase 2Completed
CompareCT.gov

Randomized Open Label PhII Trial of Neoadjuvant Trastuzumab Emtansine(Te) in Combination w/Lapatinib(L) Followed by Abraxane (A) Compared w/Trastuzumab Plus Pertuzumab Followed by Paclitaxel in Her2/Neu Over-Expressed Breast Cancer Patients

The Methodist Hospital Research Institute·interventional·Posted Feb 27, 2014·Updated Sep 22, 2021

In Brief

A Phase 2 clinical trial evaluating T-DM1, Trastuzumab, and 4 other interventions for Breast Cancer. Completed, enrolled 32 participants across 3 sites.

Detailed Summary

This is a randomized, open label Phase II neoadjuvant study comparing the efficacy and safety of trastuzumab emtansine (T-DM1) plus lapatinib (L)followed by abraxane (A) versus trastuzumab plus pertuzumab followed by paclitaxel in patients with HER2-overexpressing breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsCelgene Corporation, Novartis

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 27, 2014
Enrollment StartFeb 1, 2014
Primary CompletionJan 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 12.3 years ago

Interventions

T-DM1drug

antibody-drug conjugate of trastuzumab and emtansine

Trastuzumabdrug

anti-Her2 monoclonal antibody

Lapatinibdrug

Dual tyrosine kinase inhibitor (HER2 and EGFR)

Abraxanedrug

albumin-bound paclitaxel. chemotherapy - microtubule inhibitor.

Paclitaxeldrug

chemotherapy - microtubule inhibitor

Pertuzumabdrug

anti-HER2 monoclonal antibody