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Trial of Neoadjuvant Trastuzumab Emtansine in Patients With HER2-Equivocal Breast Cancer

NCT02725541 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2016-09-14

No results posted yet for this study

Summary

This is an open label, neoadjuvant phase II study to evaluate the objective response, toxicity, and safety of trastuzumab emtansine in patients with newly diagnosed HER2-equivocal breast cancer. Trastuzumab emtansine at a dose of 3.6 mg/kg will be intravenously administered every 3 weeks for a total of 6 weeks. Patients who achieve a partial or complete response after the 6-week treatment (responders) will continue on trastuzumab emtansine for an additional 12 weeks.

Conditions

Interventions

DRUG

Trastuzumab emtansine

HER2-targeted antibody drug conjugate of trastuzumab and DM1

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • The Methodist Hospital Research Institute

    collaborator OTHER

  • Jenny C. Chang, MD

    lead OTHER

Principal Investigators

  • Jenny C. Chang, M.D. · Houston Methodist Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2019-04-30
Completion
2019-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02725541 on ClinicalTrials.gov