A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients with Breast Cancer (Morpheus-Breast Cancer) - CO42867

F. Hoffmann-La Roche AG0 个研究点目标入组 210 人开始时间: 2024年4月26日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•Cohort-1: Documented estrogen receptor+ tumor according to American Society of Clinical Oncology/College of American Pathologists guidelines, assessed locally and defined as >= 1% of tumor cells stained positive based on the most recent tumor biopsy or archived tumor sample, Cohort-1: Patients for whom endocrine therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines, Cohort-1: Radiologic/objective evidence of recurrence or progression after the most recent systemic therapy for breast cancer, Cohort-2: Documented ER + tumor according to ASCO/CAP guidelines, assessed locally and defined as >= 1% of tumor cells stained positive based on the most recent tumor biopsy. Patient must be considered appropriate for ET and anti-HER2 therapy, Cohort-1 and Cohort 2: Measurable disease according to RECIST v1.1, Cohort-2:HER2-positive as defined by ASCO/CAP guidelines

•Cohort-1: Known HER2-positive breast cancer, Cohort-1: Prior treatment with cytotoxic chemotherapy for metastatic breast cancer (except for single agent capecitabine, which will count as a line of therapy), Cohort-1: Prior treatment with SERD (except fulvestrant), Cohort-2: Prior treatment with any of the protocol specified study treatments, Cohort-2: Systemic treatment for breast cancer within 2 weeks of Day 1 of Cycle 1 or 5 half-lives of the drug (whichever is longer) prior to Day 1 of Cycle 1, Cohort-2: Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study

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