Breast Cancer Clinical Trial
Official title:
A Phase 1B Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer
The purpose of the study is identify the dose(s) of infigratinib to use in combination with tamoxifen to treat patients with a particular type of advanced breast cancer (hormone receptor-positive, HER2-negative, FGFR-altered breast cancer)
Primary Objective: Determine the maximum (no greater than 125 mg) dose of infigratinib used in combination with the FDA-approved dose and schedule of tamoxifen (Cohort 1) in terms of the number of dose-limiting toxicities observed in the first 2 cycles of therapy in subjects with hormone receptor-positive, HER2-negative advanced breast cancer. Secondary Objective: - Estimate the incidence of treatment-emergent adverse events (serious and non-serious). - Estimate the objective tumor response rate (ORR) in subjects with measurable disease. - Estimate the progression-free survival (PFS). - Estimate the durable clinical benefit rate. ;
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