A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC
Trial Parameters
Brief Summary
This is a Study to Evaluate the Efficacy and Safety of Multiple Combination Therapies with FWD1802 in Subjects with ER-positive/HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer
Eligibility Criteria
Inclusion Criteria: * Subjects consent to provide blood samples for centralized laboratory testing of ESR1 mutation status and other biomarkers. * Histologically or cytologically confirmed ER-positive/HER2-negative locally advanced or metastatic breast cancer * Subjects must meet at least one of the following criteria: postmenopausal or prior bilateral oophorectomy, or postmenopausal or Premenopausal/perimenopausal women must agree to receive and maintain approved luteinizing hormone-releasing hormone (LHRH) agonist therapy during study treatment * Prior Therapy Requirements:Subjects must meet all of the following criteria: 1. Progression during/after, intolerance to, ineligibility for, or refusal of standard therapy 2. Endocrine therapy history: Recurrence during or within 1 year after completing ≥2 years of adjuvant endocrine therapy;OR progression after ≥1 line of endocrine therapy for advanced breast cancer(ABC) with ≥6 months of maintenance therapy (no restriction on the number of