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
Status: RECRUITING
Study type: INTERVENTIONAL
Conditions: 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
Interventions: BIOLOGICAL: Trastuzumab Emtansine|DRUG: Placebo Administration|DRUG: Tucatinib|OTHER: Questionnaire Administration|OTHER: Quality-of-Life Assessment
Sponsor: Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)|Seagen Inc.