Rogaratinib, Palbociclib y Fulvestrant in Patients With Breast Cancer.

PHASE1CompletedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

November 25, 2020

Primary Completion Date

April 4, 2023

Study Completion Date

April 4, 2023

Conditions
Breast Cancer MetastaticHormone Receptor Positive Malignant Neoplasm of Breast
Interventions
DRUG

Combination, Rogaratinib + palbociclib + fulvestrant

"Patients will receive rogaratinib, palbociclib and fulvestrant in cycles of 28 days.~Escalation Dose will follow a classic 3+3 schedule.The planned dose-levels are as follows:~* Level 1: Rogaratinib 400 mg PO BID + standard fulvestrant 500 mg every 2nd weeks until the start of the 2nd cycle, becoming every 4 weeks + palbociclib 100 mg PO per day until day 22 followed by a 7-day rest, escalable to 125 mg per day in cycle 2 (N = 3 patients).~* Level 2: Rogaratinib 600 mg PO BID + fulvestrant 500 mg IM every 2nd weeks until the start of the 2nd cycle, becoming every 4 weeks + palbociclib 100 mg PO per day until day 22 followed by a 7-day rest, escalable to 125 mg per day in cycle 2 (N = 6 patients).~Treatment will continue until disease progression."

Trial Locations (8)

25198

Hospital Universitari Arnau de Vilanova de Lleida, Lleida

28034

Hospital Ramon y Cajal, Madrid

28223

Hospital Quirónsalud Madrid, Pozuelo de Alarcón

28942

Hospital Universitario de Fuenlabrada, Fuenlabrada

08908

Institut Català d'oncologia - Hospital Duran I Reynals, L'Hospitalet de Llobregat

Unknown

Hospital Clinico San Carlos, Madrid

Hospital Universitario 12 de Octubre, Madrid

Hospital Clínico Universitario de Valencia, Valencia

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

collaborator

Pfizer

INDUSTRY

collaborator

Apices Soluciones S.L.

INDUSTRY

lead

Fundacion CRIS de Investigación para Vencer el Cáncer

OTHER