Status:
TERMINATED
A Study of TAS-120 in Patients With Metastatic Breast Cancer
Lead Sponsor:
Taiho Oncology, Inc.
Conditions:
Metastatic Breast Cancer
FGFR 1 High Amplification
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of the trial is to evaluate a patient's response to a Fibroblast Growth Factor Receptor (FGFR) inhibitor, futibatinib (TAS-120), used either alone or in combination with the hormonal thera...
Detailed Description
This is a Phase 2, open-label, non-randomized, multicenter study designed to evaluate the efficacy and safety of futibatinib (TAS-120) and futibatinib + fulvestrant in up to 168 adult patients with lo...
Eligibility Criteria
Inclusion
- Provide written informed consent
- Age ≥ 18 years of age
- Histologically or cytologically confirmed recurrent locally advanced or metastatic breast cancer not amenable to treatment with curative intent, and the following cohort specific criteria:
- A. Cohort 1
- HR+ HER2- breast cancer harboring an FGFR2 gene amplification.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- Has received 1-3 prior endocrine-containing therapies and up to 2 prior chemotherapy regimens for advanced/metastatic disease
- Has received prior treatment with a CDK4/6 inhibitor or is ineligible for such treatment
- B. Cohort 2
- TNBC harboring an FGFR2 gene amplification
- Measurable disease per RECIST 1.1
- Has received at least 1 prior chemotherapy or chemotherapy/immunotherapy (PD-L1/PD-1 inhibitors) regimen for advanced/metastatic disease
- C. Cohort 3
- TNBC or HR+ HER2- breast cancer harboring an FGFR2 gene amplification
- Non measurable, evaluable disease per RECIST 1.1. Patients with bone-only disease must have lytic or mixed lytic-blastic lesions
- Other criteria for either HR+ HER2- breast cancer or TNBC should be met as described for Cohort 1 and 2, respectively
- D. Cohort 4
- HR+ HER2- breast cancer harboring an FGFR1 high-level gene amplification
- Measurable disease per RECIST 1.1
- Has received 1-2 prior endocrine-containing therapies and no more than 1 prior chemotherapy regimen for advanced/metastatic disease. Prior treatment with fulvestrant is not permitted.
- Has received prior treatment with a CDK4/6 inhibitor or is ineligible for such treatment
- Pre/peri-menopausal patients must be on goserelin
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Archival or (preferably) fresh tumor tissue must be available
- Adequate organ function
Exclusion
- History and/or current evidence of any of the following disorders:
- Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant
- Ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, or myocardia and lung, considered clinically significant
- Retinal or corneal disorder confirmed by retinal/corneal examination and considered clinically significant
- Prior treatment with an FGFR inhibitor
- A serious illness or medical condition(s)
- Brain metastases that are untreated or clinically or radiologically unstable
- Pregnant or lactating female
Key Trial Info
Start Date :
January 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2023
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04024436
Start Date
January 28 2020
End Date
September 6 2023
Last Update
November 13 2025
Active Locations (37)
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1
Mayo Clinic - AZ
Phoenix, Arizona, United States, 85054
2
USCF
San Francisco, California, United States, 94115
3
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
4
Mayo Clinic - FL
Jacksonville, Florida, United States, 32224