Breast Cancer Clinical Trial

A Study of TAS-120 in Patients With Metastatic Breast Cancer

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 therapy, fulvestrant. This study will be conducted in patients with metastatic breast cancer who have specific Fibroblast Growth Factor Receptor gene abnormalities and who have previously received conventional therapies to treat their breast cancer, or who are not able to tolerate certain cancer therapies. This study will also evaluate the safety of taking futibatinib, or futibatinib and fulvestrant, by learning about the potential side effects.

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Full 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 locally advanced/metastatic breast cancer harboring FGFR gene amplifications. Patients will be enrolled to 1 of 4 treatment cohorts based on diagnosis and FGFR gene amplification status, and will receive either single agent futibatinib in Cohorts 1-3 or futibatinib plus fulvestrant in Cohort 4, as follows:

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

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

168

Study ID:

NCT04024436

Recruitment Status:

Recruiting

Sponsor:

Taiho Oncology, Inc.

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There are 34 Locations for this study

See Locations Near You

Mayo Clinic - AZ
Phoenix Arizona, 85054, United States
USCF
San Francisco California, 94158, United States More Info
Hope Rugo
Contact
415-353-7070
[email protected]
Florida Cancer Specialists
Fort Myers Florida, 33901, United States
Mayo Clinic - FL
Jacksonville Florida, 32224, United States
Florida Cancer Specialists
Saint Petersburg Florida, 33705, United States
Florida Cancer Specialists
Tallahassee Florida, 32308, United States
Florida Cancer Specialists
West Palm Beach Florida, 33401, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Aditya Bardia
Contact
617-724-4800
[email protected]
BIDMC
Boston Massachusetts, 02115, United States More Info
Gerburg Wolf, MD
Principal Investigator
Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States More Info
DF Trial Hotline
Contact
877-338-7425
Mayo Clinic - MN
Rochester Minnesota, 55905, United States More Info
Megan Ihrke
Contact
507-538-5843
Paige Schreifels
Contact
507-266-0539
HCA Midwest Health
Kansas City Missouri, 64132, United States
Tennessee Oncology
Chattanooga Tennessee, 37404, United States More Info
Ask Sarah Hotline
Contact
844-482-4812
Tennessee Oncology
Nashville Tennessee, 37203, United States More Info
Ask Sarah Hotline
Contact
[email protected]
UT Southwestern
Dallas Texas, 75390, United States More Info
Nisha Unni, MD
Contact
214-648-4180
[email protected]
Melanie Hullings
Contact
214-648-7097
[email protected]
MD Anderson
Houston Texas, 77030, United States More Info
Senthil Damodaran, MD
Contact
713-792-2817
[email protected]
Tom Baker Cancer Center
Calgary , T2N 4, Canada More Info
SunnyBrook Health Sciences
Toronto , M4N 3, Canada More Info
Rosanna Pezo
Contact
416-480-4757
[email protected]
Institut Gustave Roussy
Villejuif Cedex, 94805, France More Info
Andre Fabrice
Contact
+ 33 142 11 50 05
[email protected]
Centre Leon Berard
Lyon , 69008, France More Info
Thomas Bachelot
Contact
+33 478 78 26 54
[email protected]
AOU Policlinico - Vittorio Emanuele
Catania , 95123, Italy More Info
Cristina Del Re
Contact
+39.095.378.2660
[email protected]
Istituto Europeo Di Oncologia - IEO
Milano , 20141, Italy More Info
Giuseppe Campenni
Contact
39 0257489970
[email protected]
AOU Modena Policlinico
Modena , , Italy More Info
Federico Piacentini
Contact
+39 059 4223200
[email protected]
Ospedale E. Agnelli
Pinerolo , 10064, Italy More Info
Marco Tampellini
Contact
39 0121233095
[email protected]
Azienda Ospedaliero Universitaria Pisana
Pisa , 56126, Italy More Info
Andrea Fontana
Contact
+39 050 992070
[email protected]
Istituto Nazionale Tumori Regina Elena
Roma , 00144, Italy More Info
Paola Malaguti
Contact
39 0652666919
[email protected]
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma , 00168, Italy More Info
Luciana Giannone
Contact
+39 06 3015 5202
[email protected]
Centro Hospitalar Universitario Lisboa Norte
Lisboa , 1649-, Portugal More Info
Porto University
Porto , 4099-, Portugal More Info
Joana Simoes
Contact
+351 222 077 500
[email protected]
Instituto Portugues de Oncologia do Porto
Porto , 4200-, Portugal More Info
Marta Ferreira
Contact
+351 225 084 000
[email protected]
Vall d'Hebron
Barcelona , 08035, Spain More Info
Esther Zamora
Contact
34932746000
[email protected]
University Gregorio Marañon
Madrid , 28007, Spain More Info
Miguel Martin
Contact
+34 91 426 95 24
[email protected]
START Madrid - CIOCC
Madrid , 28050, Spain More Info
HCA Healthcare UK
London England, W1G 6, United Kingdom More Info
Timothy Crook
Contact
+0203 219 5200
[email protected]
The Christie NHS Foundation Trust
Manchester England, M20 4, United Kingdom More Info
Chiara O'Brien
Contact
44 161 918 7469
[email protected]
The Royal Marsden NHS Foundation Trust
Sutton England, SM2 5, United Kingdom More Info
Nick Turner
Contact
+44 207 352 8133

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

168

Study ID:

NCT04024436

Recruitment Status:

Recruiting

Sponsor:


Taiho Oncology, Inc.

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