TerminatedPhase 2

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

Stopped: The Sponsor decided to discontinue the study due to strategic considerations and not due to any safety-related concerns.

United States64 participantsStarted 2020-01-28

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:
✓. 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

What they're measuring

Objective Response Rate (ORR) - Cohorts 1, 2

Timeframe: At the end of every 2 cycles until disease progression (up to 40 months)

Clinical Benefit Rate (CBR) - Cohort 3

Timeframe: At the end of every 2 cycles until disease progression (up to 40 months)

6-month Progression-free Survival (PFS) Rate - Cohort 4

Timeframe: At the end of every 2 cycles until disease progression (up to 6 months)

Trial details

NCT IDNCT04024436

SponsorTaiho Oncology, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-31

Results submitted2025-10-15

View on ClinicalTrials.gov More Metastatic Breast Cancer trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:
✓. 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

What they're measuring

Objective Response Rate (ORR) - Cohorts 1, 2

Timeframe: At the end of every 2 cycles until disease progression (up to 40 months)

Clinical Benefit Rate (CBR) - Cohort 3

Timeframe: At the end of every 2 cycles until disease progression (up to 40 months)

6-month Progression-free Survival (PFS) Rate - Cohort 4

Timeframe: At the end of every 2 cycles until disease progression (up to 6 months)