Site for 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
Site for CompassHER2 RD (A011801) is a randomized trial in patients with residual disease after a predefined course of neoadjuvant HER2-directed treatment. While CompassHER2 RD allows entry for eligible patients who did not participate in CompassHER2 pCR, there is high interest in maximizing participation from CompassHER2 pCR in whom substantial data regarding preoperative clinical and biologic characteristics will already have been obtained. We estimate that 30-50% of patients who will participate in CompassHER2 RD will also have participated in CompassHER2 pCR; the other 50-70% of patients will be recruited separately. Patients treated with de-escalated therapy on CompassHER2 pCR will be required to receive further standard of care chemotherapy (e.g. AC X 4 or Carboplatin-H(P) x 4, TH(P)) prior to randomization on CompassHER2 RD. Therefore, CompassHER2 pCR participants must have completed at least 6 cycles of chemotherapy (including treatment administered pre and postoperatively) to be eligible for CompassHER2 RD. Enrollees who did not participate in CompassHER2 pCR must have already completed a standard HER2-directed neoadjuvant regimen (e.g. TCH(P) x 6, or AC-TH(P)), so will receive no additional systemic therapy prior to randomization. In CompassHER2 RD, eligible participants with HER2-positive residual disease will be randomized 1:1 to complete a total of 14 cycles of T-DM1 and placebo vs. T-DM1 and tucatinib, with concurrent standard endocrine therapy, if applicable. Adjuvant radiotherapy +/- endocrine therapy, as applicable, can be administered in conjunction with T-DM1 and tucatinib/placebo. Selected patients who have already begun or completed adjuvant radiotherapy, and/or who have recently commenced adjuvant T-DM1 as standard of care, may also be eligible.
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.
