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T-DM1+Pertuzumab in Pre-OP Early-Stage HER2+ BRCA

NCT02326974 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2026-04-17

Study results available
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Summary

This research study is studying a combination of drugs as a possible treatment for breast cancer that has tested positive for a protein called HER2.

The names of the study interventions involved in this study are:

* Trastuzumab emtansine (also called T-DM1)
* Pertuzumab

Conditions

  • HER-2 Positive Breast Cancer
  • Breast Cancer
  • Stage II Breast Cancer
  • Stage III Breast Cancer

Interventions

DRUG

T-DM1

Neoadjuvant treatment is for a total of 18 weeks.

DRUG

Pertuzumab

Neoadjuvant treatment is for a total of 18 weeks.

PROCEDURE

Excision of tumor/mastectomy

Definitive breast cancer surgery (excision or mastectomy) marks the end of protocol mandated therapy.

Sponsors & Collaborators

Principal Investigators

  • Otto Metzger, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2018-06-30
Completion
2028-01-31

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 NCT02326974 on ClinicalTrials.gov