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. 2023 Jun 5;28(10):919–e972. doi: 10.1093/oncolo/oyad164
Trial Information
Disease Breast cancer and advanced endometrial carcinoma
Stage of disease/treatment Recurrent/refractory metastatic
Prior therapy Cohort 1: >2 prior lines of hormonal therapy
Cohort 2/3: ≥1 line of chemotherapy for metastatic/recurrent disease
Type of study Phase II, single arm in 3 cohorts. Cohort1: HR-positive breast cancer, Cohort 2: TNBC, Cohort3: endometrial cancer
Primary endpoint Cohort 1: PFS
Cohort 2/3: ORR
Secondary endpoints Cohort 1: ORR, CBR, safety
Cohort 2/3: PFS, CBR, safety
Investigator’s analysis Level of activity did not meet planned endpoint. No evidence of effect on correlative endpoints.