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

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 Compared With T-DM1 and Tucatinib

  • Clinical Trial Information

    Trial Contact: Durand, Jennifer; Ribacchi, Stephanie

    Trial Phone: 321.843.2026 ; 321-841-1077

  • IRB No: C21.059.04

    Protocol Abbrev: A011801

    Principal Investigator: Nikita Chandrakant Shah, MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: COMPASSHER2

    Treatment: Arm 1: (trastuzumab emtansine, placebo) Arm 2: (trastuzumab emtansine, tucatinib)

    Therapies Involved: Medication ID: NCT04457596

  • Objective

    To determine if the invasive disease-free survival (iDFS) with T-DM1 and tucatinib is superior to the iDFS in the control arm (T-DM1 + placebo) when administered to high-risk patients with HER2-positive breast cancer and residual disease after neoadjuvant HER2-directed therapy.

  • Key Eligibility

    -Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects. Therefore, for women of childbearing potential only, a negative serum pregnancy test done ≤ 7 days prior to registration is required.
    -Age ≥ 18 years (male or female)
    - ECOG Performance Status 0-1
    -Adequate hepatic, renal, and bone marrow function
    -HER2-positive status will be based on pretreatment biopsy material and defined as an immunohistochemistry (IHC) score of 3+ and/or positive by in situ hybridization (ISH) according to current ASCO/CAP guidelines. Central testing is not required.
    -Patients with clinical stage T1-4, N0-3 disease at presentation and residual invasive disease postoperatively as defined above are eligible. (Note: Patients with T1a/bN0 tumors are not eligible).
    -Patients with residual HR-negative, HER2+ disease in the breast and/or lymph nodes per the surgical pathology report are eligible; however, patients with HR+ HER2+ cancers must have node-positive residual disease per the surgical pathology
    -Patients with 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.