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

Brief description of study

The purpose of the study is 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. We want to evaluate whether treatment with tucatinib plus T-DM1 compared to treatment with T-DM1 alone (T-DM1 plus placebo) improves the following: overall survival (OS), breast cancer free survival (BCFS), distant recurrence-free survival (DRFS), disease-free survival (DFS), brain metastases-free survival (BMFS). We want to know whether treatment with tucatinib plus T-DM1 compared to treatment with T-DM1 alone (T-DM1 plus placebo) reduces the incidence of brain metastases.


Clinical Study Identifier: s21-00659
ClinicalTrials.gov Identifier: NCT04457596
Principal Investigator: Nina D'Abreo.
Other Investigators: Yelena Novik, Maryann J Kwa, Marleen I Meyers, Gregory Edward Totero, Amanda Marie Talmadge, Sylvia Adams, Jagdeep Raince, Danielle Seidman, Alexander A Hindenburg, Caitlin Elizabeth Ryan, Anastasiya Apanasyuk, Ruth Oratz, Natalie Jill Klar, Douglas K Marks.


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