NCT03238196

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

A Phase Ib Trial of Fulvestrant, Palbociclib (CDK4/6 Inhibitor) and Erdafitinib (JNJ- 42756493,Pan-FGFR Tyrosine Kinase Inhibitor) in ER+/HER2-/FGFR-Amplified Metastatic Breast Cancer (MBC)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objectives To determine the safety and tolerability of fulvestrant, palbociclib and erdafitinib in patients with ER+/HER2-/FGFR-amplified MBC. Secondary Objectives * To determine the anti-tumor effect of fulvestrant, palbociclib and erdafitinib in patients with ER+/HER2-/FGFR-amplified MBC. * Pharmacokinetic assessments of erdafitinib Correlative Objectives * To determine the therapeutic predictive role of FGFR1-4, CCND1-2, CDK4 and CDK6 amplifications, and RB1 and ESR1 mutations on clinical outcome * To determine if the FGFR1 amplification levels is an early surrogate of response * To determine if the cfDNA results at disease progression show new genomic alterations potentially associated with resistance to CDK4/6 and FGFR inhibition * To determine pharmacodynamic biomarkers of FGFR inhibition

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Erdafitinib	4mg - 8mg
DRUG	Palbociclib	125 mg
DRUG	Fulvestrant	500 mg

Timeline

• Start date: 2017-08-18
• Primary completion: 2021-04-30
• Completion: 2024-03-20
• First posted: 2017-08-03
• Last updated: 2024-11-14
• Results posted: 2023-02-16

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study