A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
研究单位：[1]Hoffmann-La Roche[2]Disney Family Cancer Center,Burbank,California,United States,91505[3]Lawrence J. Ellison Institute for Transformative Medicine,Los Angeles,California,United States,90064[4]Georgetown Uni Hospital[5]4-N Main Hospital,Washington,District of Columbia,United States,20007[6]Medstar Research Institute,Hyattsville,Maryland,United States,20783[7]Dana Farber Cancer Institute,Boston,Massachusetts,United States,02215[8]Hightower Clinical,Oklahoma City,Oklahoma,United States,73102[9]Lumi Research,Kingwood,Texas,United States,77339[10]Kadlec Clinic Hematology and Oncology,Kennewick,Washington,United States,99336-7774[11]Swedish Medical Center,Seattle,Washington,United States,98104-1360[12]Fundación CENIT para la Investigación en Neurociencias,Buenos Aires,Argentina,C1125ABD[13]Centro Oncologico Korben[14]Oncology,Ciudad Autonoma Buenos Aires,Argentina,C1426AGE[15]Instituto de Oncología de Rosario,Rosario,Argentina,S2000KZE[16]Hospital Provincial del Centenario,Rosario,Argentina,S2002KDS[17]CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica,San Juan,Argentina,J5400DIL[18]Kinghorn Cancer Centre[19]St Vincents Hospital,Darlinghurst,New South Wales,Australia,2010[20]Gosford Hospital[21]Cancer Care Services,Gosford,New South Wales,Australia,2250[22]University of the Sunshine Coast,Sippy Downs,Queensland,Australia,4556[23]Sir Charles Gairdner Hospital[24]Medical Oncology,Perth,Western Australia,Australia,6009[25]Cliniques Universitaires St-Luc,Bruxelles,Belgium,1200[26]Jessa Zkh (Campus Virga Jesse),Hasselt,Belgium,3500[27]Hospital Araujo Jorge[28]Departamento de Ginecologia E Mama,Goiania,GO,Brazil,74605-070[29]Hospital do Cancer de Pernambuco - HCP,Recife,PE,Brazil,50040-000[30]Hospital do Câncer de Londrina,Londrina,PR,Brazil,86015-520[31]Hospital de Amor Amazônia,Porto Velho,RO,Brazil,76834-899[32]Santa Casa de Misericordia de Porto Alegre,Porto Alegre,RS,Brazil,90020-090[33]Hospital Sao Lucas - PUCRS,Porto Alegre,RS,Brazil,90610-000[34]Hospital de Cancer de Barretos,Barretos,SP,Brazil,14784-400[35]Instituto do Cancer do Estado de Sao Paulo - ICESP,Sao Paulo,SP,Brazil,01246-000[36]Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda,Sao Paulo,SP,Brazil,01317-001[37]Jewish General Hospital,Montreal,Quebec,Canada,H3T 1E2[38]Hôpital du Sacré-Coeur de Montreal,Montreal,Quebec,Canada,H4J 1C5[39]Hopital du Saint Sacrement,Quebec City,Quebec,Canada,G1S 4L8[40]Allan Blair Cancer Center,Regina,Saskatchewan,Canada,S4T 7T1[41]Affiliated Hospital of Hebei University[42]Department of medical oncology,Baoding,China,071000[43]Beijing Cancer Hospital,Beijing,China,100142[44]The First Hospital of Jilin University,Changchun City,China,130021[45]Sichuan Provincial Cancer Hospital,Chengdu,China,610041[46]Sichuan Provincial People's Hospital,Chengdu,China,610072[47]Fujian Cancer Hospital,Fuzhou,China,350014[48]The Second Affiliated Hospital of Zhejiang University School of Medicine,Hangzhou City,China,310009[49]Zhejiang Cancer Hospital[50]Breast Surgery,Hangzhou City,China,310022[51]Harbin Medical University Tumor Hospital[52]Department of Surgery[53]Pharmacy,Harbin,China,150049[54]Shandong Cancer Hospital,Jinan,China,250117[55]The First Affiliated Hospital to Henan University of Science and Technology,Luoyang City,China,471031[56]The Second Affiliated Hospital to Nanchang University,Nanchang,China,330006[57]Shantou Center Hospital,Shantou City,China,515031[58]Tianjin Cancer Hospital[59]Department of Breast Oncology,Tianjin,China,300000[60]Union Hospital Tongji Medical College Huazhong University of Science and Technology,Wuhan City,China,430023[61]Hubei Cancer Hospital,Wuhan,China,430079[62]Queen Mary Hospital[63]Dept. of Clinical Oncology,Hong Kong,Hong Kong[64]National Cancer Center,Goyang-si,Korea, Republic of,1040
研究目的：
This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).
