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

NCT03238196 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-11-14

Study results available
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Summary

This is an open-label, multi-institution, phase Ib trial that evaluates the safety and tolerability and preliminary anti-tumor activity of fulvestrant, palbociclib and erdafitinib in patients with ER+/HER2-/FGFR-amplified metastatic breast cancer.

Conditions

Interventions

DRUG

Erdafitinib

4mg - 8mg

DRUG

Palbociclib

125 mg

DRUG

Fulvestrant

500 mg

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Vanderbilt-Ingram Cancer Center

    lead OTHER

Principal Investigators

  • Brent Rexer, MD, PhD · Vanderbilt-Ingram Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-18
Primary Completion
2021-04-30
Completion
2024-03-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03238196 on ClinicalTrials.gov