9
Participants
Start Date
November 25, 2020
Primary Completion Date
April 4, 2023
Study Completion Date
April 4, 2023
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."
Hospital Universitari Arnau de Vilanova de Lleida, Lleida
Hospital Ramon y Cajal, Madrid
Hospital Quirónsalud Madrid, Pozuelo de Alarcón
Hospital Universitario de Fuenlabrada, Fuenlabrada
Institut Català d'oncologia - Hospital Duran I Reynals, L'Hospitalet de Llobregat
Hospital Clinico San Carlos, Madrid
Hospital Universitario 12 de Octubre, Madrid
Hospital Clínico Universitario de Valencia, Valencia