Spots Global Cancer Trial Database for A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With The Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer)
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Trial Identification
Brief Title: A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With The Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer)
Official Title: A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With The Physician's Choice of Endocrine Therapy Plus Everolimus in Patients With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
Study ID: NCT05306340
Study Description
Brief Summary: This Phase III, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus everolimus compared with the physician's choice of endocrine therapy plus everolimus in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have had previous treatment with cyclin-dependent kinase 4/6 inhibitors (CDK4/6is) and endocrine therapy, either in the locally advanced/metastatic or the adjuvant setting.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alabama Oncology - Bruno Cancer Center, Birmingham, Alabama, United States
Gulf Health Hospitals, Inc. d/b/a Infirmary Cancer Care, Mobile, Alabama, United States
Alaska Oncology and Hematology, Anchorage, Alaska, United States
The Dignity Health Cancer Institute, Phoenix, Arizona, United States
Arizona Oncology Associates, PC-CASA, Tucson, Arizona, United States
Yuma Regional Medical Center Cancer Center, Yuma, Arizona, United States
Genesis Cancer Center, Hot Springs, Arkansas, United States
University of Arkansas for Medical Sciences; Winthrop Rockefeller Cancer Institute, Little Rock, Arkansas, United States
Pacific Cancer Medical Center, Anaheim, California, United States
Alta Bates Summit Medical Center; Comprehensive Cancer Center, Berkeley, California, United States
Beverly Hills Cancer Center, Beverly Hills, California, United States
TOI Clinical Research, Cerritos, California, United States
Newport Beach UC Irvine Medical Center, Costa Mesa, California, United States
Women's Cancer Care, Fresno, California, United States
Scripps Health; Scripps Cancer Center, La Jolla, California, United States
Los Angeles Hematology Oncology Medical Group, Los Angeles, California, United States
University of California, Irvine Medical Center, Orange, California, United States
Emad Ibrahim, Md, Inc, Redlands, California, United States
Brian LeBerthon, Med Corp, West Covina, California, United States
Yale Cancer Center; Medical Oncology, New Haven, Connecticut, United States
Eastern CT Hematology and Oncology Associates, Norwich, Connecticut, United States
ASCLEPES Research Centers - Brooksville, Brooksville, Florida, United States
Broward Health Medical Center (BHMC) (Broward General Medical Center (BGMC)), Fort Lauderdale, Florida, United States
Mount Sinai Medical Center, Miami Beach, Florida, United States
Orlando Health Cancer Institute, Orlando, Florida, United States
Cancer Care Centers of Brevard, Rockledge, Florida, United States
Florida Cancer Specialists, West Palm Beach, Florida, United States
Piedmont Atlanta Hospital, Atlanta, Georgia, United States
Piedmont Fayette Hospital, Fayetteville, Georgia, United States
Northwest Georgia Oncology Centers PC - Marietta, Marietta, Georgia, United States
Piedmont Newnan Hospital, Newnan, Georgia, United States
Summit Cancer Care PC, Savannah, Georgia, United States
Piedmont Henry Hospital, Stockbridge, Georgia, United States
St Luke?s Cancer Institute, Boise, Idaho, United States
Northwestern University; Robert H. Lurie Comp Can Ctr, Chicago, Illinois, United States
Southern Illinois University, School of Medicine, Simmons Cancer Institute, Springfield, Illinois, United States
Springfield Clinic; Department of Hematology and Oncology, Springfield, Illinois, United States
Duly Health and Care, Tinley Park, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
Mission Cancer + Blood - IMMC, Des Moines, Iowa, United States
University of Kansas Cancer Center, Westwood, Kansas, United States
Pikeville Medical Center, Pikeville, Kentucky, United States
LSU Health Baton Rouge; North Clinic, Baton Rouge, Louisiana, United States
Our Lady of the Lake Physicians Group; Hematology/Oncology, Baton Rouge, Louisiana, United States
Woman's Hospital, Baton Rouge, Louisiana, United States
Pontchartrain Cancer Center, Covington, Louisiana, United States
Northern Light Cancer Center/Oncology Research, Brewer, Maine, United States
New England Cancer Specialists, Scarborough, Maine, United States
Anne Arundel Health System Research Institute, Annapolis, Maryland, United States
University of Maryland Greenebaum Cancer Center, Baltimore, Maryland, United States
Mercy Medical Center, Baltimore, Maryland, United States
TidalHealth Peninsula Regional; Richard A. Henson Research, Ocean Pines, Maryland, United States
Sinai Hospital of Baltimore Inc, Randallstown, Maryland, United States
TidalHealth Peninsula Regional, Salisbury, Maryland, United States
Sinai Hospital of Baltimore; Wiliam E. Kahlert Regional Cancer Center, Westminster, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Dana Farber/Harvard Cancer Center (Foxborough), Foxboro, Massachusetts, United States
Dana Farber/Harvard Cancer Center (Milford), Milford, Massachusetts, United States
Dana Farber/Harvard Cancer Center (Weymouth), Weymouth, Massachusetts, United States
Michigan Center of Medical Research, Farmington Hills, Michigan, United States
Metro-Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, United States
Oncology Hematology West PC, Grand Island, Nebraska, United States
Nebraska Cancer Specialists; Oncology Hematology West, PC, Omaha, Nebraska, United States
Renown Regional Medical Center, Reno, Nevada, United States
Memorial Sloan Kettering - Basking Ridge; Pharmacy, Basking Ridge, New Jersey, United States
Summit Medical Group; MD Anderson Cancer Center, Florham Park, New Jersey, United States
Memorial Sloan Kettering - Monmouth, Middletown, New Jersey, United States
Memorial Sloan-Kettering Cancer Center; Hematology/Oncology, Montvale, New Jersey, United States
San Juan Oncology Associates, Farmington, New Mexico, United States
Memorial Sloan Kettering, Commack, New York, United States
Memorial Sloan Kettering Cancer Center at Westchester, Harrison, New York, United States
Memorial Sloan Kettering Cancer Center; Drug Shipment, Long Island City, New York, United States
The Blavatnik Family ? Chelsea Medical Center at Mount Sinai, New York, New York, United States
Icahn School of Medicine at Mount Sinai; Department of Pharmacy, New York, New York, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Memorial Sloan-Kettering Cancer Center; Hematology/Oncology, New York, New York, United States
Stony Brook University Medical Center, Stony Brook, New York, United States
Memorial Sloan Kettering Cancer Center at Nassau, Uniondale, New York, United States
Cape Fear Valley Medical Center, Fayetteville, North Carolina, United States
The Gabrail Pharmacology Phase 1 Research Center LLC, Canton, Ohio, United States
SCRI Mark H. Zangmeister Center, Columbus, Ohio, United States
University of Oklahoma Health Sciences Center; Peggy and Charles Stephenson Oklahoma Cancer Center, Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute, Tulsa, Oklahoma, United States
St Charles Medical Center Bend; ATTN: Research, Bend, Oregon, United States
Oncology Research Office, Harrisburg, Pennsylvania, United States
Abramson Cancer Center; Univ of Pennsylvania, Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center - Magee-Women?s Hospital, Pittsburgh, Pennsylvania, United States
Abramson Cancer Center Chester County Hospital; Hematology, Medical Oncology, West Chester, Pennsylvania, United States
McGlinn Cancer Institute at Reading Hospital, West Reading, Pennsylvania, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
West Cancer Center, Germantown, Tennessee, United States
Thompson Cancer Survival Center, Knoxville, Tennessee, United States
Texas Oncology P.A - Beaumont, Beaumont, Texas, United States
Texas Oncology, Bedford, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Texas Oncology-Denton South, Denton, Texas, United States
Texas Oncology, P.A. - El Paso; El Paso Cancer Treatment Center, West, El Paso, Texas, United States
Methodist Hospital Research Institute, Houston, Texas, United States
Millennium Research & Clinical Development, Houston, Texas, United States
Lumi Research, Kingwood, Texas, United States
Texas Oncology Central - South, McAllen, Texas, United States
USOR - Texas Oncology - San Antonio Northeast, San Antonio, Texas, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Inova Fairfax Hospital, Falls Church, Virginia, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Multicare Institute for Research and Innovation, Tacoma, Washington, United States
Northwest Medical Specialties, PLLC; Research Department, Tacoma, Washington, United States
UW Cancer Center at ProHealth, Waukesha, Wisconsin, United States
Instituto Angel Roffo, Ciudad Autonoma Buenos Aires, , Argentina
Consultorios Médicos Dr. Doreski, Ciudad Autonoma Buenos Aires, , Argentina
Centro de Neurociencias Invest y Tratamiento, Ciudad Autonoma de Buenos Aires, , Argentina
Sanatorio Allende, Cordoba, , Argentina
Centro Medico Privado CEMAIC, Cordoba, , Argentina
Hospital Privado de La Comunidad, Mar Del Plata, , Argentina
Fundacion Centro Oncologico de Integracion Regional (COIR), Mendoza, , Argentina
Centro de Investigacion Pergamino SA, Pergamino, , Argentina
Instituto Medico de la Fundacion Estudios Clinicos, Rosario, , Argentina
Sanatorio Parque S.A., Rosario, , Argentina
Hospital Provincial del Centenario, Rosario, , Argentina
Instituto de Oncologia de Rosario, Rosario, , Argentina
Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan, San Juan, , Argentina
Organizacion Medica de Investigacion, San Nicolás, , Argentina
Centro de Investigación Clínica ? Clínica Viedma, Viedma, , Argentina
Marienhospital Bottrop, Bottrop, , Germany
St. Johannes-Hospital, Dortmund, , Germany
Frauenarztpraxis Dr. Apel, Dr. Kolpin, Erfurt, , Germany
Universitaetsklinikum Erlangen, Erlangen, , Germany
Kliniken Essen-Mitte, Essen, , Germany
Franziskus-Hospital Harderberg, Georgsmarienhutte, , Germany
Universitätsklinikum Heidelberg, Heidelberg, , Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz, Mainz, , Germany
University of Athens Medical School - Regional General Hospital Alexandra, Athens, , Greece
Attikon University General Hospital, Chaidari, , Greece
Metropolitan General Hospital, Cholargos, , Greece
University General Hospital of Heraklion, Heraklio, , Greece
University General Hospital of Larissa, Larissa, , Greece
IASO Obstetrics Gynecology Clinic, Marousi, , Greece
Agios Loucas Clinic SA, Panorama, , Greece
Olympion Clinic, Patras, , Greece
University General Hospital of Patras, Patras, , Greece
Metaxa Cancer Hospital of Piraeus, Peiraias, , Greece
Interbalkan Medical Center of Thessaloniki, Thessaloniki, , Greece
Euromedica PPDS, Thessaloniki, , Greece
Azienda Ospedaliero - Universitaria di Modena Policlinico, Modena, Emilia-Romagna, Italy
Istituto Nazionale Tumori Regina Elena IRCCS, Roma, Lazio, Italy
Ospedale Policlinico San Martino, Genova, Liguria, Italy
Asst Grande Ospedale Metropolitano Niguarda, Milano, Lombardia, Italy
Universita Degli Studi Di Milano-Bicocca - Azienda Ospedaliera San Gerardo Di Monza, Monza, Lombardia, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti, Torrette Di Ancona, Marche, Italy
Azienda Ospedaliero Universitaria di Ferrara - U.O. Di Oncologia, Cona (FE), Veneto, Italy
"Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento", Verona, Veneto, Italy
Aichi Cancer Center, Aichi, , Japan
Nagoya University Hospital, Aichi, , Japan
Chiba Cancer Center, Chiba, , Japan
National Cancer Center Hospital East, Chiba, , Japan
Shikoku Cancer Center, Ehime, , Japan
Fukushima Medical University Hospital, Fukushima, , Japan
Hiroshima City Hiroshima Citizens Hospital, Hiroshima, , Japan
Hiroshima University Hospital, Hiroshima, , Japan
Hokkaido University Hospital, Hokkaido, , Japan
Hyogo Cancer Center, Hyogo, , Japan
University of Tsukuba Hospital, Ibaraki, , Japan
Kanagawa Cancer Center, Kanagawa, , Japan
Tokai University Hospital, Kanagawa, , Japan
Kumamoto University Hospital, Kumamoto, , Japan
Kyoto University Hospital, Kyoto, , Japan
Niigata Cancer Center Hospital, Niigata, , Japan
Naha-nishi Clinic, Okinawa, , Japan
National Hospital Organization Osaka National Hospital, Osaka, , Japan
Osaka International Cancer Institute, Osaka, , Japan
Juntendo University Hospital, Tokyo, , Japan
The Cancer Institute Hospital of JFCR, Tokyo, , Japan
Chungbuk National University Hospital, Cheongju si, , Korea, Republic of
Soon Chun Hyang University Cheonan Hospital, Dongnam-gu, Cheonan-si, , Korea, Republic of
National Cancer Center, Goyang-si, , Korea, Republic of
CHA Bundang Medical Center, Gyeonggi-do, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System - PPDS, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
National University Hospital, Singapore, , Singapore
Oncocare Cancer Centre, Singapore, , Singapore
Rainbow Oncology Private Practice, Amanzimtoti, , South Africa
Wits Health Research, City Of Johannesburg, , South Africa
Hopelands Cancer Centre, Hilton, , South Africa
Medical Oncology Centre of Rosebank; Oncology, Johannesburg, , South Africa
Wilgers Oncology Centre, Pretoria, , South Africa
Hospital Dexeus; Oncología, Barcelona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
C.H. Regional Reina Sofia - PPDS, Cordoba, , Spain
Hospital Universitario Virgen de Las Nieves, Granada, , Spain
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología, La Coruña, , Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia, Murcia, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Changhua Christian Hospital, Chang Hua, , Taiwan
Chang Gung Memorial Hospital, Kaohsiung Country, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology, Taipei City, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital - Linkou Branch, Taipei, , Taiwan
Memorial Ankara Hastanesi, Ankara, , Turkey
Dicle University Medical Faculty, Diyarbak?r, , Turkey
Dorset County Hospital, Dorchester, , United Kingdom
North Middlesex Uni Hospital; Haematology Dept, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Nottingham City Hospital, Nottingham, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Genentech, Inc.
Role: STUDY_DIRECTOR
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