373
Participants
Start Date
August 3, 2022
Primary Completion Date
July 16, 2025
Study Completion Date
October 15, 2026
Giredestrant
Participants will receive treatment with giredestrant 30 milligrams (mg) orally once a day (QD) on Days 1-28 of each 28-day cycle until unacceptable toxicity or disease progression as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1).
Exemestane
If exemestane is chosen as the physician's choice of endocrine therapy, the participant will receive exemestane at a dose of 25 mg orally once a day (QD) on Days 1-28 of each 28-day cycle or as per local label, until unacceptable toxicity or disease progression as determined by investigator according to RECIST v1.1.
Fulvestrant
If fulvestrant is chosen as the physician's choice of endocrine therapy, the participant will receive fulvestrant in the clinic at a dose of 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, then Day 1 of each cycle thereafter (1 cycle is 28 days) or as per local prescribing information, until unacceptable toxicity or disease progression as determined by investigator according to RECIST v1.1.
Tamoxifen
If tamoxifen is chosen as the physician's choice of endocrine therapy, the participant will receive tamoxifen at a dose of 20 mg orally QD on Days 1-28 of each 28-day cycle or as per local prescribing information, until unacceptable toxicity or disease progression as determined by investigator according to RECIST v1.1.
Everolimus
Participants will receive treatment with everolimus 10 mg orally QD during each 28-day cycle until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.
LHRH Agonist
Only premenopausal/perimenopausal female participants and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist on Day 1 of each 28-day treatment cycle. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.
Dexamethasone Mouth Rinse
A compounded alcohol-free mouthwash of dexamethasone (0.5 mg in 5 mL) will be supplied, where feasible. It is strongly recommended for prophylaxis or treatment of stomatitis/mucositis. Participants should use the alcohol-free mouthwash of dexamethasone four times QD for 8 weeks started concurrently with study treatment, and use it reactively thereafter with the first appearance of symptoms.
Koo Foundation Sun Yat-Sen Cancer Center, Taipei
Changhua Christian Hospital, Chang-hua
SAKARYA University Medical Faculty, Sakarya
Chang Gung Memorial Hospital, Kaohsiung Country
Medical Oncology Centre of Rosebank, Johannesburg
Hopelands Cancer Centre, Hilton
Rainbow Oncology Private Practice, eManzimtoti
The Blavatnik Family ? Chelsea Medical Center at Mount Sinai, New York
Icahn School of Medicine at Mount Sinai, New York
Icahn School of Medicine at Mount Sinai, New York
Memorial Sloan-Kettering Cancer Center, New York
National Cancer Center, Goyang-si
Memorial Sloan Kettering Cancer Center at Westchester, Harrison
Memorial Sloan Kettering Cancer Center, Long Island City
Memorial Sloan Kettering Cancer Center at Nassau, Uniondale
Memorial Sloan Kettering, Commack
Stony Brook University Medical Center, Stony Brook
Attikon University General Hospital, Athens
Seoul National University Bundang Hospital, Seongnam-si
C.H. Regional Reina Sofia - PPDS, Córdoba
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología, A Coruña
UPMC Hillman Cancer Center - Magee-Women?s Hospital, Pittsburgh
Ospedale Policlinico San Martino, Genoa
Abramson Cancer Center, Philadelphia
Abramson Cancer Center Chester County Hospital, West Chester
McGlinn Cancer Institute at Reading Hospital, West Reading
Asst Grande Ospedale Metropolitano Niguarda, Milan
University of Maryland Greenebaum Cancer Center, Baltimore
Mercy Medical Center, Baltimore
Anne Arundel Health System Research Institute, Annapolis
Inova Fairfax Hospital, Fairfax
Virginia Cancer Specialists, Fairfax
Virginia Oncology Associates, Norfolk
Hospital General Universitario Gregorio Marañon, Madrid
Hospital Universitario Ramón y Cajal, Madrid
Hospital Clinico San Carlos, Madrid
Hospital Universitario 12 de Octubre, Madrid
Chungbuk National University Hospital, Cheongju-si
Hospital General Universitario J.M Morales Meseguer, Murcia
Northwest Georgia Oncology Centers PC - Marietta, Marietta
Soon Chun Hyang University Cheonan Hospital, Dongnam-gu, Cheonan-si
Summit Cancer Care PC, Savannah
Orlando Health Cancer Institute, Orlando
Cancer Care Centers of Brevard, Palm Bay
Mount Sinai Medical Center, Miami Beach
Broward Health Medical Center (BHMC) (Broward General Medical Center (BGMC)), Fort Lauderdale
Florida Cancer Specialists, West Palm Beach
Tampa General Hospital Cancer Institute, Tampa
Alabama Oncology - Bruno Cancer Center, Birmingham
"Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento", Verona
West Cancer Center, Germantown
Azienda Ospedaliero - Universitaria di Modena Policlinico, Modena
Pikeville Medical Center, Pikeville
SCRI Mark H. Zangmeister Center, Columbus
Kliniken Essen-Mitte, Essen
Hospital Clinico Universitario de Valencia, Valencia
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis
Marienhospital Bottrop, Bottrop
Universitatsklinikum Munster, Münster
Mission Cancer + Blood - IMMC, Des Moines
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz, Mainz
Metro-Minnesota Community Oncology Research Consortium, Saint Louis Park
Avera Cancer Institute, Sioux Falls
Azienda Ospedaliero Universitaria Ospedali Riuniti, Torrette Di Ancona
Northwestern University, Chicago
Springfield Clinic, Springfield
University of Kansas Cancer Center, Westwood
Oncology Hematology West, PC dba Nebraska Cancer Specialists, Omaha
Oncology Hematology West PC, Grand Island
Universitätsklinikum Heidelberg, Heidelberg
Pontchartrain Cancer Center, Covington
National Cheng Kung University Hospital, Tainan City
Our Lady of the Lake Physicians Group, Baton Rouge
Woman's Hospital, Baton Rouge
Genesis Cancer Center, Hot Springs
University of Oklahoma Health Sciences Center, Oklahoma City
Oklahoma Cancer Specialists and Research Institute, Tulsa
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Bedford
Texas Oncology-Denton South, Denton
Houston Methodist Cancer Center, Houston
Millennium Research & Clinical Development, Houston
Texas Oncology P.A - Beaumont, Beaumont
Texas Oncology P.A., San Antonio
Texas Oncology, P.A. - El Paso, El Paso
St Luke?s Cancer Institute, Boise
The Dignity Health Cancer Institute, Phoenix
Arizona Oncology Associates, PC-CASA, Tucson
San Juan Oncology Associates, Farmington
Renown Regional Medical Center, Reno
Los Angeles Hematology Oncology Medical Group, Los Angeles
Beverly Hills Cancer Center, Beverly Hills
TOI Clinical Research, Cerritos
Universitaetsklinikum Erlangen, Erlangen
Scripps Health, La Jolla
Emad Ibrahim, Md, Inc, Redlands
Newport Beach UC Irvine Medical Center, Costa Mesa
Pacific Cancer Medical Center, Anaheim
University of California, Irvine Medical Center, Orange
Women's Cancer Care, Fresno
Alta Bates Summit Medical Center, Berkeley
St Charles Medical Center Bend, Bend
Northwest Medical Specialties, PLLC, Tacoma
Alaska Oncology & Hematology, LLC, Anchorage
National Taiwan University Hospital, Taipei
National University Hospital, Singapore
Oncocare Cancer Centre, Singapore
University of Arkansas for Medical Sciences, Little Rock
Brian LeBerthon, Med Corp, West Covina
Yale Cancer Center, New Haven
Memorial Ankara Hastanesi, Ankara
Eastern Maine Medical Center, Brewer
New England Cancer Specialists, Scarborough
Dana Farber Cancer Institute, Boston
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center, Milford
Memorial Sloan Kettering - Basking Ridge, Basking Ridge
Summit Medical Group, Florham Park
Memorial Sloan Kettering - Monmouth, Middletown
Memorial Sloan-Kettering Cancer Center, Montvale
Thompson Cancer Survival Center, Knoxville
Instituto de Oncología Ángel H. Roffo, Agronomía
Fundación CENIT para la Investigación en Neurociencias, Recoleta
Consultorios Médicos Dr. Doreski, Ciudad Autonoma Buenos Aires
Centro Medico Privado CEMAIC, Córdoba
Fundacion Centro Oncologico de Integracion Regional (COIR), Mendoza
Instituto Medico de la Fundacion Estudios Clinicos, Rosario
Sanatorio Parque S.A., Rosario
Hospital Provincial del Centenario, Rosario
Instituto de Oncologia de Rosario, Rosario
Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan, San Juan
Organizacion Medica de Investigacion, San Nicolás
Centro de Investigación Clínica ? Clínica Viedma, Viedma
University of Athens, Hematological Clinic,, Athens
Metropolitan General Hospital, Cholargós
University General Hospital of Heraklion, Heraklio
University General Hospital of Larissa, Larissa
IASO Obstetrics Gynecology Clinic, Marousi
Agios Loucas Clinic SA, Panórama
Olympion Clinic, Pátrai
University General Hospital of Patras, Pátrai
Metaxa Cancer Hospital of Piraeus, Piraeus
Interbalkan Medical Center of Thessaloniki, Thessaloniki
Euromedica PPDS, Thessaloniki
Istituto Nazionale Tumori Regina Elena IRCCS, Rome
Aichi Cancer Center, Aichi
Nagoya University Hospital, Aichi
Chiba Cancer Center, Chiba
National Cancer Center Hospital East, Chiba
Shikoku Cancer Center, Ehime
Hiroshima City Hiroshima Citizens Hospital, Hiroshima
Hiroshima University Hospital, Hiroshima
Hokkaido University Hospital, Hokkaido
Hyogo Cancer Center, Hyōgo
University of Tsukuba Hospital, Ibaraki
Kanagawa Cancer Center, Kanagawa
Tokai University Hospital, Kanagawa
Kumamoto University Hospital, Kumamoto
Niigata Cancer Center Hospital, Niigata
National Hospital Organization Osaka National Hospital, Osaka
Juntendo University Hospital, Tokyo
The Cancer Institute Hospital of JFCR, Tokyo
Seoul National University Hospital, Seoul
Severance Hospital Yonsei University Health System - PPDS, Seoul
Korea University Guro Hospital, Seoul
Hospital Dexeus, Barcelona
Hospital Clinic de Barcelona, Barcelona
Chang Gung Memorial Hospital - Linkou Branch, Taipei
Dorset County Hospital, Dorchester
North Middlesex Uni Hospital, London
The Christie NHS Foundation Trust, Manchester
Nottingham City Hospital, Nottingham
Lead Sponsor
Genentech, Inc.
INDUSTRY