Cancer Type: Breast
Study Type: Treatment
NCT#: NCT04024436
Phase: Phase II
Principal Investigator: Soyano Muller, Aixa
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).
Therapy (NOS)
Faslodex (fulvestrant); TAS-120 (); fulvestrant ()
If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.
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