The STOP-HER2 TBCRC062 Trial:Outcomes in Patients with HER2+ Metastatic Breast Cancer

What is the Purpose of this Study?

We are doing this study to find out if anti-HER2 treatment can be safely stopped in patients with metastatic HER2+ breast cancer who have had an exceptional response to treatment for at least 3 years.

What is the Condition Being Studied?

Metastatic HER2+ breast cancer

Who Can Participate in the Study?

Adults ages 18+ who:

  • Are diagnosed with metastatic HER2+ breast cancer
  • Have been on first-line anti-HER2 therapy for at least 3 years
  • Have not had any disease progression

For more information about who can join this study, please contact the study team at breastcl@dm.duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, you will:

  • Make a choice to participate in 1 of 2 groups
    • You can continue to receive the anti-HER2 therapy you are taking; OR
    • You can stop taking anti-HER2 therapy
  • Have blood draws
  • Have imaging scans
  • Complete questionnaires
  • Give us permission to use your stored tissue samples

Study Details

Full Title
A Phase 2 Study of Stopping Trastuzumab - Outcomes in Patients with HER2+ Metastatic Breast Cancer
Principal Investigator
Headshot of Kelly W Westbrook
Assistant Professor of Medicine
Protocol Number
IRB: PRO00113523
NCT: NCT05721248
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
OPEN TO ACCRUAL
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