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

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
Medical Oncologist
Protocol Number
IRB: PRO00113523
NCT: NCT05721248
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment