A Study of TAS-120 in Patients With Metastatic Breast Cancer (NCT04024436) | Clinical Trial Compass
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 States, Canada, France64 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 range
18 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate (ORR) - Cohorts 1, 2
Timeframe: At the end of every 2 cycles until disease progression (up to 40 months)
2
Clinical Benefit Rate (CBR) - Cohort 3
Timeframe: At the end of every 2 cycles until disease progression (up to 40 months)
. 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