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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

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

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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 outcome measures

FGFR1 Amplification Levels by FISH and cfDNA

Next Generation Sequencing

Plasma Cell-free Deoxyribonucleic Acid (cfDNA)

+1 more

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

~3760

Fulvestrant

2011

Completed Phase 3

~3690

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt-Ingram Cancer CenterLead Sponsor

213 Previous Clinical Trials

60,898 Total Patients Enrolled

28 Trials studying Breast Cancer

6,594 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,687 Previous Clinical Trials

40,930,336 Total Patients Enrolled

941 Trials studying Breast Cancer

1,543,396 Patients Enrolled for Breast Cancer

Ingrid Mayer, MDPrincipal InvestigatorVanderbilt-Ingram Cancer Center

11 Previous Clinical Trials

309 Total Patients Enrolled

8 Trials studying Breast Cancer

195 Patients Enrolled for Breast Cancer

Media Library

Erdafitinib (FGFR Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03238196 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial have availability for new participants?

"This clinical trial is no longer accepting additional participants. This study was first posted on August 18th 2017 and last updated May 24th 2022. If you're in search of other studies, there are 2297 trials that are recruiting patients suffering from breast cancer and 247 researching the efficacy of Erdafitinib currently enrolling volunteers."

Answered by AI

How many participants have been assigned to this research study?

"This trial is currently not enrolling new participants. It was first listed on August 18th 2017, and the most recent amendment to its listing occurred on May 24th 2022. Alternately, there are 2297 clinical trials for breast cancer that are actively seeking patients as well as 247 studies focussing on Erdafitinib."

Answered by AI

What is the total quantity of medical centers administering this trial?

"This clinical trial has 9 sites in total, with Memorial Sloan-Kettering Cancer Center located in New york City, University of Alabama present in Birmingham and Vanderbilt-Ingram Cancer Center situated within Nashville. The other 6 locations are scattered throughout the country."

Answered by AI

What precedent has been set by preceding trials involving Erdafitinib?

"Since its inception at Lowell General Hospital in 2004, erdafitinib has been subject to 164 completed clinical trials. Currently, 247 studies are actively recruiting participants, with a substantial number located in the city of New york."

Answered by AI

Has Erdafitinib been authorized by the FDA?

"The safety profile of Erdafitinib has been judged to be a 1, as this is an early-stage trial with limited data on its efficacy and potential risks."

Answered by AI

What indications are usually linked to Erdafitinib treatments?

"Erdafitinib is commonly prescribed to combat the symptoms of malignant neoplasms, as well as pik3ca gene mutation and disease progression. In some cases it may also be used in conjunction with endocrine therapy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fulvestrant, Palbociclib and Erdafitinib in ER+/HER2-/FGFR-amplified Metastatic Breast Cancer

Brent Rexer 2017. "Fulvestrant, Palbociclib and Erdafitinib in ER+/HER2-/FGFR-amplified Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03238196.

All > Metastatic Breast Cancer