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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

Testing T-DM1 and Tucatinib for high-risk HER2-positive breast cancer prevention.

Recruiting
18 years and older
All
Phase 3

This study is looking at how well two drugs, T-DM1 and tucatinib, work to stop breast cancer from coming back in people with a high risk of the disease. T-DM1 is a type of treatment that combines a targeted therapy, trastuzumab, with a chemotherapy drug, DM1, to attack specific cancer cells. Tucatinib works by blocking enzymes that help cancer cells grow. The study compares the effectiveness of using both drugs together versus using T-DM1 alone. Participants will be randomly assigned to receive either both drugs or just T-DM1 and a placebo.

Key Points:

  • The study lasts for up to 14 cycles, with each cycle being 21 days long.
  • Participants will need to attend follow-up visits every 6 months for 10 years after treatment.
  • Compensation or specific risks are not mentioned, but participants should discuss with their doctors.
Study details
    Anatomic Stage IA Breast Cancer AJCC V8
    Anatomic Stage II Breast Cancer AJCC V8
    Anatomic Stage IIA Breast Cancer AJCC V8
    Anatomic Stage IIB Breast Cancer AJCC V8
    Anatomic Stage III Breast Cancer AJCC V8
    Anatomic Stage IIIA Breast Cancer AJCC V8
    Anatomic Stage IIIB Breast Cancer AJCC V8
    Anatomic Stage IIIC Breast Cancer AJCC V8
    HER2 Positive Breast Carcinoma
    Invasive Breast Carcinoma
    Multifocal Breast Carcinoma
    Prognostic Stage I Breast Cancer AJCC V8
    Prognostic Stage IA Breast Cancer AJCC V8
    Prognostic Stage IB Breast Cancer AJCC V8
    Prognostic Stage II Breast Cancer AJCC V8
    Prognostic Stage IIA Breast Cancer AJCC V8
    Prognostic Stage IIB Breast Cancer AJCC V8
    Prognostic Stage III Breast Cancer AJCC V8
    Prognostic Stage IIIA Breast Cancer AJCC V8
    Prognostic Stage IIIB Breast Cancer AJCC V8
    Prognostic Stage IIIC Breast Cancer AJCC V8
    Synchronous Bilateral Breast Carcinoma

NCT04457596

Alliance for Clinical Trials in Oncology

19 January 2025

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