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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 belowSelect...
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
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 moreOther outcome measures
FGFR1 Amplification Levels by FISH and cfDNA
Next Generation Sequencing
Plasma Cell-free Deoxyribonucleic Acid (cfDNA)
+1 moreTrial 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
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
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
Find a Location
Who is running the clinical trial?
Vanderbilt-Ingram Cancer CenterLead Sponsor
214 Previous Clinical Trials
60,958 Total Patients Enrolled
28 Trials studying Breast Cancer
6,594 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,328 Total Patients Enrolled
942 Trials studying Breast Cancer
1,543,966 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My wounds heal slowly.I can swallow and keep down pills.I am fully active or restricted in physically strenuous activity but can do light work.My cancer can be measured and there's tissue available for testing.I've had more than 2 chemotherapy treatments for cancer that has spread, but any number of hormone therapies is okay.I have not had radiation therapy in the last 2 weeks.I stopped my cancer treatment (except hormone therapy) at least 1 week ago.I am not on any cancer treatments not approved in this study, but I may be taking bisphosphonates or denosumab.I have not had major surgery in the last 4 weeks.I have stopped taking herbal supplements 14 days before starting the study.I have no eye conditions that could worsen with treatment.I do not have any uncontrolled illnesses affecting my stomach, lungs, heart, or mental health.I have brain metastases that are causing symptoms.I am 18 years old or older.I am a woman who cannot become pregnant due to menopause.My breast cancer is at stage IV or cannot be removed by surgery and meets certain biomarker criteria.I have received at least one treatment for my cancer after it spread.I am currently taking medication that needs approval for this study.My blood, liver, and kidney functions meet the required levels.I have previously used an FGFR inhibitor.I have a history of chronic liver or kidney failure.
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