A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer)
研究单位:[1]Hoffmann-La Roche[2]Genesis Cancer Center,Hot Springs,Arkansas,United States,71913[3]Los Angeles Hematology Oncology Medical Group,Los Angeles,California,United States,90017[4]St Mary's Hospital and Medical Center,Grand Junction,Colorado,United States,81501[5]Cancer Specialists of North Florida,Jacksonville,Florida,United States,32256-6932[6]Florida Cancer Specialists - EAST - SCRI - PPDS,West Palm Beach,Florida,United States,33401-3406[7]Maryland Oncology Hematology - Annapolis,Annapolis,Maryland,United States,21401[8]Swedish Cancer Institute,Cary,North Carolina,United States,27513[9]Hightower Clinical,Oklahoma City,Oklahoma,United States,73102[10]West Cancer Center,Germantown,Tennessee,United States,38138[11]Texas Oncology - Austin,Austin,Texas,United States,78745[12]Texas Oncology - DFW,Dallas,Texas,United States,75246[13]Texas Oncology - El Paso,El Paso,Texas,United States,79902[14]Virginia Oncology Associates,Norfolk,Virginia,United States,23502[15]Swedish Cancer Institute - Edmonds Campus,Edmonds,Washington,United States,98026[16]Swedish Cancer Institute - Issaquah,Issaquah,Washington,United States,98029[17]Fundación CENIT para la Investigación en Neurociencias,Buenos Aires,Argentina,C1125ABD[18]Centro Oncologico Korben[19]Oncology,Ciudad Autonoma Buenos Aires,Argentina,C1426AGE[20]Centro Oncologico Riojano Integral (CORI),La Rioja,Argentina,F5300COE[21]Fundacion Scherbovsky,Mendoza,Argentina,M5500AYB[22]Instituto de Oncología de Rosario,Rosario,Argentina,S2000KZE[23]Hospital Provincial del Centenario,Rosario,Argentina,S2002KDS[24]CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica,San Juan,Argentina,J5400DIL[25]Cliniques Universitaires St-Luc,Bruxelles,Belgium,1200[26]GHdC Site Notre Dame,Charleroi,Belgium,6000[27]UZ Gent,Gent,Belgium,9000[28]Jessa Zkh (Campus Virga Jesse),Hasselt,Belgium,3500[29]UZ Leuven Gasthuisberg,Leuven,Belgium,3000[30]Clinique Ste-Elisabeth,Namur,Belgium,5000[31]Hospital Sao Rafael - HSR,Salvador,BA,Brazil,41253-190[32]Pronutrir - suporte nutricional e quimioterapia ltda.,Fortaleza,CE,Brazil,60810-180[33]Hospital Araujo Jorge[34]Departamento de Ginecologia E Mama,Goiania,GO,Brazil,74605-070[35]Hospital do Cancer de Pernambuco - HCP,Recife,PE,Brazil,50040-000[36]Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda,Ijui,RS,Brazil,98700-000[37]Hospital Nossa Senhora da Conceicao,Porto Alegre,RS,Brazil,91350-200[38]Fundação Pio XII Hospital de Câncer de Barretos,Barretos,SP,Brazil,14784-400[39]Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda,Sao Paulo,SP,Brazil,01317-001[40]Affiliated Hospital of Hebei University[41]Department of medical oncology,Baoding,China,071000[42]Peking University People's Hospital,Beijing,China,100044[43]the First Affiliated Hospital of Bengbu Medical College,Bengbu City,China,233000[44]The First Hospital of Jilin University,Changchun City,China,130021[45]Hunan Cancer Hospital,Changsha CITY,China,410013[46]Sichuan Cancer Hospital,Chengdu City,China,610041[47]West China Hospital - Sichuan University,Chengdu City,China,610047[48]No. 900 Hospital (Fuzhou General Hospital),Fuzhou City,China,350009[49]Fujian Cancer Hospital,Fuzhou,China,350014[50]Zhejiang Cancer Hospital
研究目的:
This Phase III, randomized, two-arm, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus Phesgo compared with Phesgo after induction therapy with Phesgo plus taxane in participants with human epidermal growth factor receptor 2 (HER2)-positive, estrogen receptor (ER)-positive advanced breast cancer (metastatic or locally advanced disease not amenable to curative treatment) who have not previously received a systemic non-hormonal anti-cancer therapy in the advanced setting.