A Study of TAS-120 in Patients With Metastatic Breast Cancer
NCT ID: NCT04024436
Last Updated: 2025-11-13
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
64 participants
INTERVENTIONAL
2020-01-28
2023-09-06
Brief Summary
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Detailed Description
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* Cohort 1 - HR+ HER2- Measurable Disease w/ FGFR2 Amplification
* Cohort 2 - TNBC Measurable Disease w/ FGFR2 Amplification
* Cohort 3 - HR+ HER2- or TNBC Non-Measurable Disease w/ FGFR2 Amplification
* Cohort 4 - HR+ HER2- Measurable Disease w/ FGFR1 Amplification
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Futibatinib (Cohort 1)
Participants with advanced or metastatic hormone receptor - positive (HR+), human epidermal growth factor receptor 2 - negative (HER2-) breast cancer, harboring fibroblast growth factor receptor 2 (FGFR2) gene amplification, with measurable disease received futibatinib, 20 milligrams (mg), oral tablets, once daily for a continuous 28-day cycle up to maximum of 244 days.
Futibatinib
Futibatinib 20mg once daily on a 28-day cycle
Futibatinib (Cohort 2)
Participants with advanced or metastatic triple negative breast cancer (TNBC), harboring FGFR2 gene amplification, with measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 1066 days.
Futibatinib
Futibatinib 20mg once daily on a 28-day cycle
Futibatinib (Cohort 3)
Participants with advanced or metastatic HR+, HER2- or TNBC, harboring FGFR2 gene amplification, with non-measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 252 days.
Futibatinib
Futibatinib 20mg once daily on a 28-day cycle
Futibatinib Plus Fulvestrant (Cohort 4)
Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days. They also received intramuscular (IM) fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.
Futibatinib plus Fulvestrant
Futibatinib 20mg once daily on a 28-day cycle and fulvestrant 500 mg administered intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond on a 28-day cycle.
Interventions
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Futibatinib
Futibatinib 20mg once daily on a 28-day cycle
Futibatinib plus Fulvestrant
Futibatinib 20mg once daily on a 28-day cycle and fulvestrant 500 mg administered intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond on a 28-day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years of age
3. 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
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
5. Archival or (preferably) fresh tumor tissue must be available
6. Adequate organ function
Exclusion Criteria
1. Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant
2. Ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, or myocardia and lung, considered clinically significant
3. Retinal or corneal disorder confirmed by retinal/corneal examination and considered clinically significant
2. Prior treatment with an FGFR inhibitor
3. A serious illness or medical condition(s)
4. Brain metastases that are untreated or clinically or radiologically unstable
5. Pregnant or lactating female
18 Years
ALL
No
Sponsors
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Taiho Oncology, Inc.
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic - AZ
Phoenix, Arizona, United States
USCF
San Francisco, California, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Mayo Clinic - FL
Jacksonville, Florida, United States
Florida Cancer Specialists
St. Petersburg, Florida, United States
Florida Cancer Specialists
Tallahassee, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Florida Cancer Specialists
West Palm Beach, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
BIDMC
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic - MN
Rochester, Minnesota, United States
HCA Midwest Health
Kansas City, Missouri, United States
Tennessee Oncology
Chattanooga, Tennessee, United States
Tennessee Oncology
Nashville, Tennessee, United States
UT Southwestern
Dallas, Texas, United States
MD Anderson
Houston, Texas, United States
Tom Baker Cancer Center
Calgary, , Canada
SunnyBrook Health Sciences
Toronto, , Canada
Institut Gustave Roussy
Villejuif, Cedex, France
Centre Leon Berard
Lyon, , France
AOU Policlinico - Vittorio Emanuele
Catania, , Italy
Istituto Europeo Di Oncologia - IEO
Milan, , Italy
AOU Modena Policlinico
Modena, , Italy
Ospedale E. Agnelli
Pinerolo, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Istituto Nazionale Tumori Regina Elena
Roma, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, , Italy
Centro Hospitalar Universitario Lisboa Norte
Lisbon, , Portugal
Porto University
Porto, , Portugal
Instituto Portugues de Oncologia do Porto
Porto, , Portugal
Vall d'Hebron
Barcelona, , Spain
University Gregorio Marañon
Madrid, , Spain
START Madrid - CIOCC
Madrid, , Spain
HCA Healthcare UK
London, England, United Kingdom
The Christie NHS Foundation Trust
Manchester, England, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, England, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-001164-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
FOENIX-MBC2 TAS-120-201
Identifier Type: -
Identifier Source: org_study_id