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ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer

NCT03587740 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2026-05-18

Study results available
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Summary

This research study is studying an investigational drug as a possible treatment for breast cancer that is positive for the protein Human Epidermal Growth Factor Receptor 2, also known as HER2-positive breast cancer.

The drug involved in this study is:

-ado-trastuzumab emtansine (T-DM1)

Conditions

Interventions

DRUG

T-DM1

T-DM1 is an antibody-drug conjugate; it is made up of an antibody (trastuzumab) linked to a cytotoxic drug, DM1 (chemotherapy). T-DM1 functions as a targeted cancer therapy because it targets HER2-positive breast cancer cells directly, limiting exposure of the rest of the body to chemotherapy.

Sponsors & Collaborators

  • Susan G. Komen Breast Cancer Foundation

    collaborator OTHER

  • Gateway for Cancer Research

    collaborator OTHER

  • Dana-Farber Cancer Institute

    lead OTHER

Principal Investigators

  • Rachel Freedman, MD MPH · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-22
Primary Completion
2025-03-03
Completion
2027-08-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT03587740 on ClinicalTrials.gov