Spots Global Cancer Trial Database for Rogaratinib, Palbociclib y Fulvestrant in Patients With Breast Cancer.
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Trial Identification
Brief Title: Rogaratinib, Palbociclib y Fulvestrant in Patients With Breast Cancer.
Official Title: Rogaratinib, Palbociclib and Fulvestrant in Advanced Hormone Receptor Positive, FGFR1/2/3-positive Breast Cancer: Phase I Clinical Trial Plus an Expansion Cohort
Study ID: NCT04483505
Interventions
Study Description
Brief Summary: This study is an open, multicenter, prospective phase I dose escalation clinical trial followed by an expansion cohort. The aim of this study is to asses the Recommended Phase 2 Dose (R2PD) and the safety profile, among other efficacy, in FGFR1/2/3 positive, hormone receptor-positive breast cancer (HRPBC) patients with metastatic disease after progression to the combination of an aromatase inhibitor plus palbociclib, abemaciclib or ribociclib, according RECIST 1.1 criteria.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Institut Català d'oncologia - Hospital Duran I Reynals, Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario de Fuenlabrada, Fuenlabrada, Madrid, Spain
Hospital Quirónsalud Madrid, Pozuelo De Alarcón, Madrid, Spain
Hospital Universitari Arnau de Vilanova de Lleida, Lleida, , Spain
Hospital Ramon y Cajal, Madrid, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Clínico Universitario de Valencia, Valencia, , Spain
Contact Details
Name: Miguel Ángel Quintela-Fandino
Affiliation: Centro Nacional de Investigaciones Oncológicas
Role: PRINCIPAL_INVESTIGATOR
Name: Luis Manso, MD
Affiliation: Hospital Universitario 12 de Octubre
Role: PRINCIPAL_INVESTIGATOR
Name: Ramón Colomer i Bosch
Affiliation: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Role: PRINCIPAL_INVESTIGATOR
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