Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
Study ID: NCT05894239
Conditions
Study Description
Brief Summary: 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).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner Health MD Anderson AZ, Gilbert, Arizona, United States
Disney Family Cancer Center, Burbank, California, United States
Lawrence J. Ellison Institute for Transformative Medicine, Los Angeles, California, United States
Georgetown Uni Hospital; 4-N Main Hospital, Washington, District of Columbia, United States
Medstar Research Institute, Hyattsville, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Hightower Clinical, Oklahoma City, Oklahoma, United States
Lumi Research, Kingwood, Texas, United States
Kadlec Clinic Hematology and Oncology, Kennewick, Washington, United States
Swedish Medical Center, Seattle, Washington, United States
Fundación CENIT para la Investigación en Neurociencias, Buenos Aires, , Argentina
Centro Oncologico Korben; Oncology, Ciudad Autonoma Buenos Aires, , Argentina
Instituto de Oncología de Rosario, Rosario, , Argentina
Hospital Provincial del Centenario, Rosario, , Argentina
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica, San Juan, , Argentina
Kinghorn Cancer Centre; St Vincents Hospital, Darlinghurst, New South Wales, Australia
Gosford Hospital; Cancer Care Services, Gosford, New South Wales, Australia
University of the Sunshine Coast, Sippy Downs, Queensland, Australia
Sir Charles Gairdner Hospital; Medical Oncology, Perth, Western Australia, Australia
Cliniques Universitaires St-Luc, Bruxelles, , Belgium
GHdC Site Notre Dame, Charleroi, , Belgium
Jessa Zkh (Campus Virga Jesse), Hasselt, , Belgium
Clinique Ste-Elisabeth, Namur, , Belgium
Hospital Araujo Jorge; Departamento de Ginecologia E Mama, Goiania, GO, Brazil
Hospital do Cancer de Pernambuco - HCP, Recife, PE, Brazil
Hospital do Câncer de Londrina, Londrina, PR, Brazil
Hospital de Amor Amazônia, Porto Velho, RO, Brazil
Santa Casa de Misericordia de Porto Alegre, Porto Alegre, RS, Brazil
Hospital Sao Lucas - PUCRS, Porto Alegre, RS, Brazil
Hospital de Cancer de Barretos, Barretos, SP, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP, Sao Paulo, SP, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda, Sao Paulo, SP, Brazil
Tom Baker Cancer Centre; Dept of Pathology, Calgary, Alberta, Canada
The Moncton Hospital, Moncton, New Brunswick, Canada
Eastern Health - General Hospital, St. John's, Newfoundland and Labrador, Canada
Jewish General Hospital, Montreal, Quebec, Canada
Hôpital du Sacré-Coeur de Montreal, Montreal, Quebec, Canada
Hopital du Saint Sacrement, Quebec City, Quebec, Canada
Allan Blair Cancer Center, Regina, Saskatchewan, Canada
Affiliated Hospital of Hebei University; Department of medical oncology, Baoding, , China
Beijing Cancer Hospital, Beijing, , China
The First Hospital of Jilin University, Changchun City, , China
Sichuan Provincial Cancer Hospital, Chengdu, , China
Sichuan Provincial People's Hospital, Chengdu, , China
Fujian Cancer Hospital, Fuzhou, , China
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou City, , China
Zhejiang Cancer Hospital; Breast Surgery, Hangzhou City, , China
Harbin Medical University Tumor Hospital; Department of Surgery; Pharmacy, Harbin, , China
Shandong Cancer Hospital, Jinan, , China
The First Affiliated Hospital to Henan University of Science and Technology, Luoyang City, , China
The Second Affiliated Hospital to Nanchang University, Nanchang, , China
Guangxi Cancer Hospital of Guangxi Medical University, Nanning City, , China
Shantou Center Hospital, Shantou City, , China
Tianjin Cancer Hospital; Department of Breast Oncology, Tianjin, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan City, , China
Hubei Cancer Hospital, Wuhan, , China
Clinica De La Costa, Barranquilla, , Colombia
Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo, Bogota, D.C., , Colombia
Oncomedica S.A., Monteria, , Colombia
Tampere University Hospital; Dept of Oncology, Tampere, , Finland
Turku Uni Central Hospital; Oncology Clinics, Turku, , Finland
Institut Sainte Catherine, Avignon, , France
Klinikum St. Marien; Frauenklinik, Amberg, , Germany
Marienhospital Bottrop gGmbH; Department of Gynecology and Obstetrics, Bottrop, , Germany
Gynonco Düsseldorf, MVZ Medical Center GmbH, Düsseldorf, , Germany
Frauenarztpraxis Dr. Apel, Dr. Kolpin, Erfurt, , Germany
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR, Freiburg, , Germany
Caritas Klinik St. Theresia -Frauenklinik Brustzentrum, Saarbruecken, , Germany
Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher, Stralsund, , Germany
Queen Mary Hospital; Dept. of Clinical Oncology, Hong Kong, , Hong Kong
Tuen Mun Hospital; Clinical Oncology, Hong Kong, , Hong Kong
Artemis Hospital, Gurugram, Haryana, India
Tata Medical Center, Kolkata, WEST Bengal, India
I.R.S.T Srl IRCCS; Oncologia Medica, Meldola, Emilia-Romagna, Italy
Ospedale San Giovanni Addolorata; Oncologia, Roma, Lazio, Italy
Ospedale San Raffaele; Medical Oncology, Milano, Lombardia, Italy
Ospedale San Gerardo; Centro Di Ricerca di Fase I ? Piano 8 ? Settore C, Monza, Lombardia, Italy
A.O.U. Maggiore della Carità, Novara, Piemonte, Italy
Casa di Cura La Maddalena; Oncologia Medica, Palermo, Sicilia, Italy
Ospedale Santa Maria Annunziata; Oncologia, Bagno a Ripoli, Toscana, Italy
National Cancer Center, Goyang-si, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Gangnam Severance Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul St Mary's Hospital, Seoul, , Korea, Republic of
Hospital Zambrano Hellion TecSalud, Monterrey, Nuevo LEON, Mexico
Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Ambulatorium Chemioterapii, Bydgoszcz, , Poland
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii, Gdansk, , Poland
Szpital Morski im.PCK; Oddzial Onkologii Klinicznej, Oddzial Dzienny, Gdynia, , Poland
Przychodnia Lekarska KOMED, Roman Karaszewski, Konin, , Poland
Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii, Koszalin, , Poland
National University Hospital; National University Cancer Institute, Singapore (NCIS), Singapore, , Singapore
National Cancer Centre; Medical Oncology, Singapore, , Singapore
Icon Cancer Centre Farrer Park, Singapore, , Singapore
Tan Tock Seng Hospital; Oncology, Singapore, , Singapore
Hopelands Cancer Centre, Hilton, , South Africa
Charlotte Maxeke Academic Hospital, Johannesburg, , South Africa
Medical Oncology Centre of Rosebank; Oncology, Johannesburg, , South Africa
Limpopo Cancer Research Institute, Polokwane, , South Africa
Chris Hani Baragwanath Clinical Trial Site, Soweto, , South Africa
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia, A Coruña, LA Coruña, Spain
Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica, Barcelona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia, Madrid, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia, Malaga, , Spain
Hospital Universitario Virgen Macarena; Servicio de Oncologia, Sevilla, , Spain
National Taiwan Uni Hospital; General Surgery, Taipei, , Taiwan
Tri-Service General Hospital; Department of Haematology and Oncology, Taipei, , Taiwan
Chang Gung Memorial Hospital-Linkou; Dept of Oncology, Taoyuan County, , Taiwan
Gazi University Medical Faculty, Ankara, , Turkey
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji, Bakirkoy / Istanbul, , Turkey
Dicle University Faculty of Medicine, Diyarbakir, , Turkey
Medipol Mega Üniversite Hastanesi Göztepe, Istanbul, , Turkey
Medical Park Seyhan Hospital; Oncology Department, Seyhan, , Turkey
Hacettepe Uni Medical Faculty Hospital; Oncology Dept, Sihhiye/Ankara, , Turkey
Blackpool Victoria Hospital, Blackpool, , United Kingdom
Nottingham City Hospital; Oncology, Nottingham, , United Kingdom
Churchill Hospital; Oxford Cancer and Haematology Centre, Oxford, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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