69
Participants
Start Date
October 23, 2020
Primary Completion Date
June 15, 2022
Study Completion Date
March 16, 2025
Alpelisib
Alpelisib (BYL719): starting dose at 300 mg/QD.; 2 tablets once a day, oral administration, continuously during 28-day cycles until disease progression or unacceptable toxicity.
Metformin
500 mg BID with breakfast and dinner. After 3 days, if no (GI) intolerance, increase to 1000 mg BID with breakfast and dinner. If not tolerated, reduce to prior tolerated dose. Titrate to 1000mg BID over a period of at least 4 additional days
Fulvestrant
"fulvestrant (500 mg IM injections; loading dose 500mg every two weeks for the first month; then every 4 weeks as per standard of care \[SoC\].~Patients should be started on metformin and fulvestrant within 7 to 14 days prior to start on alpelisib (D1C1)"
Letrozole
Letrozole 2.5 mg tablets, once daily, orally
Exemestane
Exemestane 25 mg tablets, once daily, orally
Vildagliptin
Vildagliptin 50 mg tablets, twice daily, orally with breakfast and dinner
Tamoxifen
Tamoxifen 20 mg tablets, once daily, orally
Hospital General Universitario de Alicante, Alicante
Hospital Universitari Vall D'Hebron, Barcelona
Institut Català d' Oncologia L'Hospitalet (ICO), Barcelona
Hospital Universitario de Basurto, Bilbao
Hospital Provincial de Castellón, Castellon
Hospital San Pedro de Alcántara, Cáceres
Onkologikoa, Donostia / San Sebastian
Hospital Universitario Clínico San Cecilio de Granada, Granada
Hospital Universitario Insular de Gran Canaria, Las Palmas de Gran Canaria
Hospital Universitario de Leon, León
Hospital Beata María Ana, Madrid
Hospital Ruber Internacional, Madrid
Hospital Universitario Doce de Octubre, Madrid
Hospital Universitario Sanchinarro, Madrid
Hospital Clínico Universitario Virgen de la Arrixaca, Murcia
Complejo Hospitalario Universitario de Santiago (CHUS), Santiago de Compostela
Hospital Universitario Virgen del Rocio, Seville
Hospital Clinico Universitario de Valencia, Valencia
Instituto Valenciano de Oncología (IVO), Valencia
Collaborators (1)
Novartis
INDUSTRY
MedSIR
OTHER