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A Prospective, Randomized Multicenter, Open-label Comparison of Preoperative Trastuzumab Emtansine (T-DM1) With or Without Standard Endocrine Therapy vs. Trastuzumab With Standard Endocrine Therapy Given for Twelve Weeks in Patients With Operable HER2+/HR+ Breast Cancer Within the ADAPT Protocol.

NCT01745965 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2025-02-27

No results posted yet for this study

Summary

Trial to optimize neoadjuvant therapy for HER overexpression and co-expressing of hormone receptors(ER and/or PR) breast cancer (HEr2+/HR+).

A new high potential trastuzumab conjugate T-DM1(trastuzumab was linked with the cytotoxic agent mertansine DM1)was tested with endocrine therapy and without against a standard arm with trastuzumab and endocrine therapy.

Conditions

Interventions

DRUG

T-DM1

DRUG

Trastuzumab

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • West German Study Group

    lead OTHER

Principal Investigators

  • Nadia Harbeck, Prof. Dr. · Breast Center of the University of Munich (LMU), Universitätsfrauenklinik Großhadern, Munich, Germany

  • Ulrike Nitz, Prof. Dr. · Ev. Krankenhaus Bethesda Brustzentrum Niederrhein, Mönchengladbach, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2015-02-28
Completion
2025-01-15

Countries

  • Germany

Study Locations

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Entities

Drugs
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 NCT01745965 on ClinicalTrials.gov