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Alliance A011801


Clinical Trial Title

The CompassHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer): CompassHER2 Residual Disease (RD), A DoubleBlinded, Phase III Randomized Trial of T-DM1 and Placebo Compared with T-DM1 and Tucatinib

Trial Status

Open to Enrollment

Start Date

May 10, 2021


Trial Type

Cancer - Adult Oncology

Specific Condition

Breast Cancer


This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone.

Eligibility Criteria

Eligibility Criteria

  • HER2-positive breast cancer.
  • Patients must have received neoadjuvant chemotherapy.
  • Prior receipt of T-DM1 in the neoadjuvant setting is not allowed.
  • No adjuvant treatment with any anti-cancer investigational drug within 28 days prior to registration
  • Age = 18 years (male or female)
  • ECOG Performance Status 0-1
  • No stage IV (metastatic) breast cancer
  • No history of any prior (ipsi- or contralateral) invasive breast cancer within 3 years of registration
  • No patients with ER+ HER2+ residual invasive disease that is lymph node-negative per the surgical pathology report
  • No evidence of recurrent disease following preoperative therapy and surgery

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.


IRB Number

Central IRB

Principal Investigator Name

Mei Dong, MD

Contact Name

Oncology Clinical Research



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Last Updated: Thursday, June 24, 2021 09:26:11 AM