379
Participants
Start Date
August 29, 2017
Primary Completion Date
June 14, 2021
Study Completion Date
November 12, 2024
Alpelisib
300 mg of alpelisib film-coated tablets administered orally once daily
Fulvestrant
500 mg of fulvestrant via intramuscular injection administered on Days 1, 15 on Cycle 1 and Day 1 at each cycle thereafter. Cycle=28 days
Letrozole
2.5 mg of letrozole film-coated tablets administered orally once daily
Goserelin
3.6 mg of goserelin via injectable subcutaneous implant administered every 28 days. Only for men in Cohort B and premenopausal women.
Leuprolide
7.5 mg of leuprolide via injectable intramuscular depot administered every 28 days. Only for men in cohort B and premenopausal women.
Novartis Investigative Site, Leuven
Novartis Investigative Site, Liège
Novartis Investigative Site, Odense C
Novartis Investigative Site, La Rioja
Novartis Investigative Site, Taipei
Memorial Sloane Ketterin Cancer Ctr, New York
Novartis Investigative Site, Castellon
Novartis Investigative Site, Caen
Novartis Investigative Site, Berlin
Novartis Investigative Site, Genova
Novartis Investigative Site, Milan
Novartis Investigative Site, Milan
Mercy Medical Center, Baltimore
Greater Baltimore Med Center Cancer Center, Baltimore
Virginia Oncology Associates, Norfolk
Novartis Investigative Site, Bergamo
Novartis Investigative Site, Madrid
Novartis Investigative Site, Toulouse
Advent Health Cancer Institute, Orlando
Novartis Investigative Site, Bordeaux
Novartis Investigative Site, Montpellier
Novartis Investigative Site, Salamanca
Novartis Investigative Site, Bologna
University of Louisville James Graham Brown Cancer Center, Louisville
Novartis Investigative Site, Seville
Uni Hosp of Cleveland Cancer Center, Cleveland
Novartis Investigative Site, Saint-Herblain
Novartis Investigative Site, Essen
Novartis Investigative Site, Jalisco
Josephine Ford Cancer Center, Detroit
Novartis Investigative Site, Lille
St Vincent Frontier Cancer Center, Billings
Novartis Investigative Site, Ancona
University of Kansas Cancer Center, Kansas City
Novartis Investigative Site, Strasbourg
Novartis Investigative Site, Heidelberg
Novartis Investigative Site, Lyon
Novartis Investigative Site, Tainan City
Texas Oncology, Dallas
Cancer Care Centers of South Texas HOAST, San Antonio
UT Health San Antonio, San Antonio
Novartis Investigative Site, Napoli
Mayo Clinic Arizona, Phoenix
Banner MD Anderson Cancer Center, Gilbert
Novartis Investigative Site, Augsburg
New Mexico Cancer Care Alliance, Albuquerque
Novartis Investigative Site, Ulm
Beverly Hills Cancer Center, Beverly Hills
Novartis Investigative Site, Erlangen
Kaiser Permanent Southern Californi, San Diego
Novartis Investigative Site, Saint-Cloud
University of Calif Irvine Med Cntr, Irvine
Kaiser Permanente Medical Group, Anaheim
UCSF, San Francisco
Northwest Medical Specialists, Tacoma
Novartis Investigative Site, Taipei
Novartis Investigative Site, Delhi
Novartis Investigative Site, Singapore
Novartis Investigative Site, Singapore
Novartis Investigative Site, Temuco
Novartis Investigative Site, Petah Tikva
Novartis Investigative Site, Ramat Gan
Novartis Investigative Site, Tel Aviv
Novartis Investigative Site, Santiago
Novartis Investigative Site, Rehovot
Novartis Investigative Site, Santiago
Yale University Yale Cancer Center, New Haven
Massachusetts General Hospital, Boston
Lahey Clinic, Burlington
Novartis Investigative Site, CABA
Novartis Investigative Site, CABA
Novartis Investigative Site, CABA
Novartis Investigative Site, Rosario
Novartis Investigative Site, Rosario
Novartis Investigative Site, Vancouver
Novartis Investigative Site, Halifax
Novartis Investigative Site, Kitchener
Novartis Investigative Site, Toronto
Novartis Investigative Site, Vejle
Novartis Investigative Site, Nice
Novartis Investigative Site, Dresden
Novartis Investigative Site, Roma
Novartis Investigative Site, Osaka
Novartis Investigative Site, Maastricht
Novartis Investigative Site, Seoul
Novartis Investigative Site, Seoul
Novartis Investigative Site, L'Hospitalet de Llobregat
Novartis Investigative Site, Barcelona
Novartis Investigative Site, Barcelona
Novartis Investigative Site, Edinburgh
Novartis Investigative Site, Sutton
Novartis Investigative Site, Leicester
Novartis Investigative Site, London
Novartis Investigative Site, Nottingham
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY