A Study of TAS-120 in Patients With Metastatic Breast Cancer
Metastatic Breast Cancer, FGFR 1 High Amplification, FGFR2 Amplification
About this trial
This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring Futibatinib, Metastatic Breast Cancer, FGFR, TAS-120
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
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
Sites / Locations
- Mayo Clinic - AZ
- USCF
- Florida Cancer Specialists
- Mayo Clinic - FL
- Florida Cancer Specialists
- Florida Cancer Specialists
- Moffitt Cancer Center
- Florida Cancer Specialists
- Massachusetts General Hospital
- BIDMC
- Dana Farber Cancer Institute
- Mayo Clinic - MN
- HCA Midwest Health
- Tennessee Oncology
- Tennessee Oncology
- UT Southwestern
- MD Anderson
- Tom Baker Cancer Center
- SunnyBrook Health Sciences
- Institut Gustave Roussy
- Centre Leon Berard
- AOU Policlinico - Vittorio Emanuele
- Istituto Europeo Di Oncologia - IEO
- AOU Modena Policlinico
- Ospedale E. Agnelli
- Azienda Ospedaliero Universitaria Pisana
- Istituto Nazionale Tumori Regina Elena
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Centro Hospitalar Universitario Lisboa Norte
- Porto University
- Instituto Portugues de Oncologia do Porto
- Vall d'Hebron
- University Gregorio Marañon
- START Madrid - CIOCC
- HCA Healthcare UK
- The Christie NHS Foundation Trust
- The Royal Marsden NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Futibatinib
Futibatinib plus Fulvestrant
Group/Cohort 1 Description HR+ HER2- Measurable Disease w/ FGFR2 Amplification Group/Cohort 2 Description TNBC Measurable Disease w/ FGFR2 Amplification Group/Cohort 3 Description HR+ HER2- or TNBC Non-Measurable Disease w/ FGFR2 Amplification
Group/Cohort 4 Description HR+ HER2- Measurable Disease w/ FGFR1 Amplification