A Phase II Study of Treatment with Ado-Trastuzumab Emtansine after Surgery in Older People with HER2-Positive Breast Cancer

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Full Title

ATOP TRIAL: Adjuvant Ado-Trastuzumab Emtansine (T-DM1) for Older Patients with Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

Purpose

The purpose of this study is to assess the safety and effectiveness of the medication ado-trastuzumab emtansine (T-DM1) in older patients with HER2-positive breast cancer who cannot receive standard chemotherapy. This anticancer drug is approved by the U.S. Food and Drug Administration to treat metastatic breast cancer as well as early-stage breast cancer that has already been treated with chemotherapy and surgery; its use after surgery for stage I, II, or III breast cancer that has not been treated with chemotherapy is considered investigational.

T-DM1 is an antibody-drug conjugate. It is made up of an antibody (trastuzumab) and a chemotherapy drug (DM1). Trastuzumab first binds to the HER2 protein on the surface of breast cancer cells, and then DM1 enters the cells and causes them to die, preventing tumor growth. Researchers think T-DM1 can be effective and cause fewer side effects than other treatments in older adults. It is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • This study is for patients age 60 or older.
  • Patients must have HER2-positive breast cancer that cannot be treated with standard chemotherapy and has been surgically removed within 90 days of entering the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.

For more information about this study and to inquire about eligibility, please contact Dr. Chau Dang at 914-367-7181.

Protocol

19-256

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators