What is the mechanism of action of this treatment?

Targeted therapies for breast cancer, such as FGFR inhibitors like Futibatinib, work by specifically targeting and inhibiting the activity of certain proteins or genes that are involved in cancer cell growth and survival. For instance, FGFR inhibitors block the fibroblast growth factor receptors, which can be abnormally activated in some breast cancers, leading to uncontrolled cell proliferation. This targeted approach is crucial for breast cancer patients as it allows for more precise treatment, potentially reducing side effects compared to conventional chemotherapy. Additionally, understanding the specific genetic abnormalities in a patient's tumor can help in selecting the most effective therapy, thereby improving outcomes and quality of life.

What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly FGFR inhibitors like futibatinib, can cause ocular toxicity (e.g., corneal defects, uveitis), muscle cramps, hair loss, and weight loss. Hormonal therapies like fulvestrant may lead to hot flashes, fatigue, and injection site reactions. Chemotherapy and anti-HER2 therapies often result in diarrhea, cardiac events, and skin reactions.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for breast cancer, particularly for hormone receptor-positive and HER2-negative subtypes. One notable example is the combination of fulvestrant, a hormonal therapy, with targeted agents like palbociclib, a CDK4/6 inhibitor, which has shown improved outcomes in patients with metastatic breast cancer. While specific FGFR inhibitors like futibatinib are still under investigation, the approach of combining targeted therapies with hormonal treatments is well-established in breast cancer management.

What other types of research exist?

Promising alternatives to Futibatinib for breast cancer patients include Palbociclib in combination with Fulvestrant, which has shown effectiveness in hormone receptor-positive, HER2-negative advanced breast cancer. Additionally, the combination of Fulvestrant and Everolimus has demonstrated safety and efficacy in similar patient populations. These treatments offer targeted approaches that may be suitable for patients seeking novel therapies in 2024.

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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.

Must not have

History and/or current evidence of 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called futibatinib, alone or with fulvestrant, in patients with advanced breast cancer with specific genetic changes. These patients have already tried other treatments or cannot tolerate them. The drug works by blocking growth signals in cancer cells. Futibatinib is a drug taken by mouth that targets certain growth signals in cancer cells.

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.

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.

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 below

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My triple-negative breast cancer has FGFR2 gene changes and I've had at least one treatment for advanced cancer.

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My breast cancer is HR positive, HER2 negative, and has an FGFR2 gene change.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a significant calcium or phosphorus balance issue not caused by cancer.

Select...

I have significant calcium deposits in organs or soft tissues.

Select...

I have been treated with an FGFR inhibitor before.

Select...

I have a serious eye condition confirmed by an eye exam.

Select...

I have brain metastases that are either untreated or not stable.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Clinical Benefit Rate (CBR) - Cohort 3

Objective Response Rate (ORR) - Cohorts 1, 2

Secondary study objectives

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.

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Futibatinib plus Fulvestrant

2020

Completed Phase 2

~170

Futibatinib

2014

Completed Phase 2

~580

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Targeted therapies for breast cancer, such as FGFR inhibitors like Futibatinib, work by specifically targeting and inhibiting the activity of certain proteins or genes that are involved in cancer cell growth and survival. For instance, FGFR inhibitors block the fibroblast growth factor receptors, which can be abnormally activated in some breast cancers, leading to uncontrolled cell proliferation. This targeted approach is crucial for breast cancer patients as it allows for more precise treatment, potentially reducing side effects compared to conventional chemotherapy. Additionally, understanding the specific genetic abnormalities in a patient's tumor can help in selecting the most effective therapy, thereby improving outcomes and quality of life.

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