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Fibroblast Growth Factor Receptor (FGFR) inhibitor
Futibatinib for Breast Cancer
Phase 2
Waitlist Available
Research Sponsored by Taiho Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For Cohort 2: TNBC harboring an FGFR2 gene amplification, with measurable disease per RECIST 1.1, having received at least 1 prior chemotherapy or chemotherapy/immunotherapy regimen for advanced/metastatic disease
HR+ HER2- breast cancer harboring an FGFR2 gene amplification.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial is testing a drug to see if it works better than current treatments for metastatic breast cancer in patients with a specific gene abnormality. They will also be testing to see if the drug has any serious side effects.
Who is the study for?
This trial is for adults with metastatic breast cancer who have FGFR gene abnormalities. They must have tried 1-3 hormone therapies and up to 2 chemotherapies, or be unable to tolerate certain treatments. Pregnant women, those with prior FGFR inhibitor treatment, significant mineralization conditions, serious eye disorders, unstable brain metastases, or clinically significant calcium-phosphorus issues are excluded.Check my eligibility
What is being tested?
The study tests the effectiveness of futibatinib alone or combined with fulvestrant in treating metastatic breast cancer with specific FGFR gene changes. It aims to understand how patients respond to these treatments after conventional therapies and assess their safety by monitoring side effects.See study design
What are the potential side effects?
Potential side effects may include reactions related to organ function due to the inhibition of FGFR pathways. Specifics aren't provided but could involve digestive issues, skin reactions, changes in vision due to retinal/corneal complications if pre-existing conditions are aggravated.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My triple-negative breast cancer has FGFR2 gene changes and I've had at least one treatment for advanced cancer.
Select...
My breast cancer is HR positive, HER2 negative, and has an FGFR2 gene change.
Select...
My breast cancer has returned, spread, and cannot be cured with surgery or radiation.
Select...
I've had 1-3 hormone therapies and up to 2 chemo treatments for advanced cancer.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
6-month Progression-free Survival (PFS) rate - Cohort 4
Clinical Benefit Rate (CBR) - Cohort 3
Objective Response Rate (ORR) - Cohorts 1, 2
Secondary outcome measures
6-month Progression-free Survival (PFS) rate - Cohorts 1-3
Clinical Benefit Rate (CBR) - Cohort 1,2, and 4
Complete Response (CR) - Cohort 3
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Futibatinib plus FulvestrantExperimental Treatment2 Interventions
Group/Cohort 4 Description HR+ HER2- Measurable Disease w/ FGFR1 Amplification
Group II: FutibatinibExperimental Treatment1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Futibatinib
2014
Completed Phase 2
~410
Find a Location
Who is running the clinical trial?
Taiho Oncology, Inc.Lead Sponsor
66 Previous Clinical Trials
11,416 Total Patients Enrolled
2 Trials studying Breast Cancer
449 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer is TNBC or HR+ HER2- with an FGFR2 gene change and can be evaluated but not measured.My breast cancer is HR positive, HER2 negative, and has an FGFR2 gene change.I have a significant calcium or phosphorus balance issue not caused by cancer.You have a measurable tumor according to specific guidelines for assessing tumor size.My breast cancer has returned, spread, and cannot be cured with surgery or radiation.I have significant calcium deposits in organs or soft tissues.I have HR+ HER2- breast cancer with specific gene changes, have tried some treatments but not more than 3 hormone therapies and 2 chemotherapies.My triple-negative breast cancer has FGFR2 gene changes and I've had at least one treatment for advanced cancer.If you have HR+ HER2- breast cancer with a specific gene change, have had a certain number of prior treatments, and meet certain health status and organ function requirements, you can join Cohort 4 of the study.I've had 1-3 hormone therapies and up to 2 chemo treatments for advanced cancer.This is not a criterion, but only a label for a specific group of participants.I have been treated with an FGFR inhibitor before.I am 18 years old or older.I have a serious eye condition confirmed by an eye exam.You have a severe illness or medical condition.I have brain metastases that are either untreated or not stable.
Research Study Groups:
This trial has the following groups:- Group 1: Futibatinib
- Group 2: Futibatinib plus Fulvestrant
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What have been the side effects of Futibatinib in combination with Fulvestrant?
"Futibatinib plus Fulvestrant is still being studied in clinical trials, so its safety rating is a 2."
Answered by AI
What are Futibatinib and Fulvestrant most frequently used to treat?
"Futibatinib in combination with Fulvestrant has been shown to be effective at treating patients that have received prior endocrine therapy, disease, or breast cancer."
Answered by AI
Are Futibatinib and Fulvestrant commonly used together in research?
"Currently, there are 147 clinical trials studying Futibatinib plus Fulvestrant. 35 of those active clinical trials are in Phase 3. While the majority of trials for Futibatinib plus Fulvestrant are based in Shanghai, China, there are 6064 locations running studies for this treatment worldwide."
Answered by AI
Are we still enrolling people in this experiment?
"Yes. The trial, which began recruitment on 8/30/2019 and was most recently updated on 10/4/2022, is still recruiting participants. There are 168 total spots at 11 different sites around the country."
Answered by AI
Are there several hospitals running this study in the city?
"Enrolment for this clinical trial is happening at 11 sites. They are situated in San Francisco, Toronto, Houston as well as 8 other locations. If you enrol in the study, try to pick a site close to your residence to limit travel time and expenses."
Answered by AI
How many individuals are involved in this research project?
"168 patients that meet the clinical trial's inclusion criteria are required in order for the study to run as planned. The sponsor, Taiho Oncology, Inc., has different medical centres across North America where the trial will take place; two examples include USCF in San Francisco and SunnyBrook Health Sciences in Toronto."
Answered by AI
Who else is applying?
What state do they live in?
California
North Carolina
Virginia
Other
How old are they?
18 - 65
What site did they apply to?
SunnyBrook Health Sciences
What portion of applicants met pre-screening criteria?
Met criteria
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