The STOP-HER2 Trial: A Phase 2 Study of Stopping Trastuzumab in People with Breast Cancer

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Full Title

The STOP-HER2 Trial: A Phase 2 Study of Stopping Trastuzumab - Outcomes in Patients with HER2+ Metastatic Breast Cancer

Purpose

HER2 is a protein made by some breast cancers. It plays a role in breast cancer growth. People with HER2-positive breast cancer may get anti-HER2 treatment, such as trastuzumab, for 3 years or more. They get it as long as it is working or until serious side effects develop.

Researchers want to see if trastuzumab can be safely stopped in people with HER2-positive metastatic breast cancer who have an exceptional response. An exceptional response means that the cancer has not grown or spread for 3 years or more since starting trastuzumab.

This study has two groups. You will choose which group you want to participate in.

  • Group 1 will continue to get trastuzumab as instructed by their doctor.
  • Group 2 will stop taking trastuzumab. People in this group may restart trastuzumab at any time if it is in their best interest.

Who Can Join

To join this study, there are a few conditions. You must:

  • Have metastatic HER2-positive breast cancer.
  • Have been getting trastuzumab for 3 years or more and had an exceptional response.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Chau Dang’s office at 646-888-5426.

Protocol

24-201

Phase

Phase II (phase 2)

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators

Diseases

ClinicalTrials.gov ID

NCT05721248