Clinical Trials THE COMPASSHER2 TRIALS (COMPREHENSIVE USE OF PATHOLOGIC RESPONSE ASSESSMENT TO OPTIMIZE THERAPY IN HER2-POSITIVE BREAST CANCER): COMPASSHER2 Residual Disease (RD), A Double-Blinded, PHASE III Randomized Trial Of T-DM1 And Placebo Compared With T-DM1 And TUCATINIB

THE COMPASSHER2 TRIALS (COMPREHENSIVE USE OF PATHOLOGIC RESPONSE ASSESSMENT TO OPTIMIZE THERAPY IN HER2-POSITIVE BREAST CANCER): COMPASSHER2 Residual Disease (RD), A Double-Blinded, PHASE III Randomized Trial Of T-DM1 And Placebo Compared With T-DM1 And TUCATINIB

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

Cooperative group phase III study of combination of tucatinib + T-DM1 vs. T-DM1 in HER2+ breast cancer patients with residual disease post neoadjuvant chemotherapy and surgery. (CompassHER2 RD).

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.

Inclusions/Exclusions:

  1. Clinical stage T1-4, N0-3 disease at presentation and residual invasive disease postoperatively as defined above are eligible.
  2. Residual HR-negative, HER2+ disease in the breast and/or lymph nodes per the surgical pathology report are eligible.
  3. Patients with HR-positive, HER2+ disease must have disease in their lymph node(s) per the surgical pathology report in order to qualify for the study. weakly ER-positive (1-10%) breast cancer (based on the pretreatment core biopsy) are eligible even if they have node-negative disease per the surgical pathology report.
  4. Residual disease tissue (breast and/or lymph nodes) is not required to be HER2-positive, as eligibility for A011801 is based on a positive HER2 status at the time of the initial breast cancer diagnosis.
  5. Synchronous bilateral invasive disease are eligible provided both lesions were confirmed to be HER2-positive, and at least one of the lesions meets the criteria outlined above. Multifocal disease is allowed, as long as the largest biopsied breast tumor was HER2-positive.
  6. No prior tx in adj setting with TDM! Allowed
  7. ECOG 0-1

HER2+ BC, NO stage IV disease allowed.

Learn More at ClinicalTrials.gov

To participate please call: 310-582-7448