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 05/10/2021
Location legacy-emanuel-medical-center
Trial Type Cancer - Adult Oncology
Specific Condition Breast Cancer
Description 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
Notes T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial - Full Text View -
Principal Investigator Mei Dong, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail