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A Phase 2 Study of TAS-120 in Metastatic Breast Cancers Harboring Fibroblast Growth Factor Receptor (FGFR) Amplifications
The purpose of this open-label, nonrandomized, Phase 2 study is to evaluate the efficacy and safety of TAS-120 and TAS-120 + fulvestrant in patients with locally advanced/metastatic breast cancer harboring FGFR gene amplifications.
Primary Objectives: The primary objective of this study is to assess the antitumor activity of TAS-120 as monotherapy or in combination with fulvestrant in the treatment of patients with metastatic breast cancer harboring FGFR amplifications, as measured by: - ORR in patients with centrally confirmed FGFR2 amplification and measurable disease(Cohorts 1, 2) - Clinical benefit rate (CBR) in patients with centrally confirmed FGFR2 amplification and nonmeasurable, evaluable disease (Cohort 3) - 6-month progression-free survival (PFS) rate in patients with centrally confirmed high level FGFR1 amplification and measurable disease (Cohort 4).
Faslodex (fulvestrant); TAS-120 (); fulvestrant ()