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FGFR Inhibitor

Triple Drug Therapy for Breast Cancer

Phase 1

Waitlist Available

Led By Ingrid Mayer, MD

Research Sponsored by Vanderbilt-Ingram Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be ≥ 18 years of age

Female patients of no childbearing potential must meet specific post-menopausal criteria

Must not have

More than 2 lines of chemotherapy in the metastatic setting. No limit on endocrine therapy lines. Prior exposure to CDK4/6 inhibitor acceptable

Prior cancer therapy (except for endocrine therapy) must have been discontinued for 1 week prior to initiation of study drugs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up imaging studies will be performed every 8 weeks from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of three drugs to treat metastatic breast cancer that is positive for estrogen receptors, negative for human epidermal growth factor receptors, and has amplified fibroblast growth factor receptors.

Who is the study for?

This trial is for adults with ER+/HER2-/FGFR-amplified metastatic breast cancer who can take oral meds, have evaluable disease and biomarker-determined tissue. They must be in good physical condition (ECOG 0-1), not of childbearing potential or meet post-menopausal criteria, and have had at most one chemo but no FGFR inhibitors in the metastatic setting.

What is being tested?

The study tests the combination of fulvestrant, palbociclib, and erdafitinib's safety and early effectiveness on patients. It's an open-label phase Ib trial where everyone knows what treatment they're getting, conducted across multiple institutions.

What are the potential side effects?

Possible side effects include issues related to eye toxicity due to erdafitinib; fatigue, nausea, low blood counts from palbociclib; and hormonal changes or injection site reactions from fulvestrant. Each drug has its own profile of potential side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am a woman who cannot become pregnant due to menopause.

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My breast cancer is at stage IV or cannot be removed by surgery and meets certain biomarker criteria.

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I have received at least one treatment for my cancer after it spread.

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I can swallow and keep down pills.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer can be measured and there's tissue available for testing.

Exclusion Criteria

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

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I've had more than 2 chemotherapy treatments for cancer that has spread, but any number of hormone therapies is okay.

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I stopped my cancer treatment (except hormone therapy) at least 1 week ago.

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I have not had major surgery in the last 4 weeks.

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I have no eye conditions that could worsen with treatment.

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I have brain metastases that are causing symptoms.

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My wounds heal slowly.

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I have previously used an FGFR inhibitor.

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I have a history of chronic liver or kidney failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ imaging studies will be performed every 8 weeks from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~imaging studies will be performed every 8 weeks from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and imaging studies will be performed every 8 weeks from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 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

Number of Participants With Dose Limiting Toxicities (DLT) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)

Secondary study objectives

Clinical Benefit Rate (CBR; Complete Response + Partial Response + Stable Disease Without Disease Progression at 6 Months)

Incidence of Treatment-Emergent Adverse Events [Tolerability]

Overall Response Rate

+5 more

Other study objectives

FGFR1 Amplification Levels by FISH and cfDNA

Next Generation Sequencing

Plasma Cell-free Deoxyribonucleic Acid (cfDNA)

+1 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: ExpansionExperimental Treatment3 Interventions

Fulvestrant - injection into muscle 1 time per month Palbociclib capsule taken by mouth 1 time per day every 21 days followed by 1 week of rest (no drug taken) Erdafitinib tablet taken by mouth 1 time per day

Group II: EscalationExperimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Erdafitinib

2017

Completed Phase 2

~150

Palbociclib

2017

Completed Phase 3