Fibroblast Growth Factor Receptor (FGFR) inhibitor

Futibatinib plus Fulvestrant for Breast Cancer

AOU Modena Policlinico, Modena, Italy
Targeting 3 different conditionsFutibatinib plus Fulvestrant +1 morePhase 2Waitlist AvailableResearch Sponsored by Taiho Oncology, Inc.

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.

Eligible Conditions
  • Metastatic Breast Cancer
  • Fibroblast Growth Factor Receptor 1 High Amplification
  • No disease or condition mentioned.

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You have been diagnosed with advanced breast cancer that has come back or spread and cannot be treated to cure the disease.
You have already tried 1-3 different hormone-based therapies and up to 2 different chemotherapy treatments for your advanced or metastatic disease.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial 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

Find a site

Who is running the clinical trial?

Taiho Oncology, Inc.Lead Sponsor
66 Previous Clinical Trials
11,642 Total Patients Enrolled
2 Trials studying Breast Cancer
428 Patients Enrolled for Breast Cancer

Media Library

Futibatinib (Fibroblast Growth Factor Receptor (FGFR) inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04024436 — Phase 2
Breast Cancer Research Study Groups: Futibatinib, Futibatinib plus Fulvestrant
Breast Cancer Clinical Trial 2023: Futibatinib Highlights & Side Effects. Trial Name: NCT04024436 — Phase 2
Futibatinib (Fibroblast Growth Factor Receptor (FGFR) inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04024436 — Phase 2

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?
North Carolina
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
~34 spots leftby Sep 2024