Spots Global Cancer Trial Database for A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy
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Trial Identification
Brief Title: A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy
Official Title: A Phase III, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Versus Alpelisib Plus Fulvestrant in Patients With Hormone Receptor-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Who Progressed During or After CDK4/6 Inhibitor and Endocrine Combination Therapy
Study ID: NCT05646862
Conditions
Study Description
Brief Summary: This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after cyclin dependent kinase 4/6i (CDK4/6i)-based therapy.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Marin Cancer Care Inc, Greenbrae, California, United States
Cancer Blood and Specialty Clinic, Los Alamitos, California, United States
Los Angeles Cancer Network, Los Angeles, California, United States
University of California, Irvine Medical Center, Orange, California, United States
UC Davis Comprehensive Cancer Center, Sacramento, California, United States
Rocky Mountain Cancer Centers, Denver, Colorado, United States
Eastern CT Hematology and Oncology Associates, Norwich, Connecticut, United States
Cancer Care Centers of Brevard, Rockledge, Florida, United States
Cleveland Clinic Florida, Weston, Florida, United States
Grady Health System, Atlanta, Georgia, United States
Midtown West Medical, Atlanta, Georgia, United States
Emory University Hospital, Atlanta, Georgia, United States
Winship Cancer Institute at Emory Saint Joseph's Hospital, Atlanta, Georgia, United States
Karmanos Cancer Institute., Detroit, Michigan, United States
Cancer & Hematology Centers of Western Michigan, Grand Rapids, Michigan, United States
Minnesota Oncology Hematology, Saint Paul, Minnesota, United States
Novant Health Presbyterain Medical Center, Charlotte, North Carolina, United States
Novant Health Forsyth Medical Center, Winston-Salem, North Carolina, United States
Gabrail Cancer Center, Canton, Ohio, United States
Asante Rogue Regional Medical Center, Medford, Oregon, United States
Consultants in Medical Oncology and Hematology, Broomall, Pennsylvania, United States
Abramson Cancer Center Chester County Hospital; Hematology, Medical Oncology, West Chester, Pennsylvania, United States
WellSpan Oncology Research, York, Pennsylvania, United States
Texas Oncology West, Amarillo, Texas, United States
Texas Oncology - Dallas Presbyterian Hospital, Dallas, Texas, United States
Texas Tech University Health Sciences Center; Department of Internal Medicine, El Paso, Texas, United States
Texas Oncology (Flower Mound) - USOR, Flower Mound, Texas, United States
The Center for Cancer and Blood Disorders - Fort Worth, Fort Worth, Texas, United States
Lumi Research, Kingwood, Texas, United States
Texas Oncology McKinney, McKinney, Texas, United States
Kadlec Clinic Hematology and Oncology, Kennewick, Washington, United States
Fundación CENIT para la Investigación en Neurociencias, Buenos Aires, , Argentina
Centro Oncologico Korben; Oncology, Ciudad Autonoma Buenos Aires, , Argentina
Fundacion CORI para la Investigacion y Prevencion del Cancer, La Rioja, , Argentina
Instituto de Oncología de Rosario, Rosario, , Argentina
Sanatorio Parque S.A., Rosario, , Argentina
Hosp Provincial D. Centenarios; Oncology Dept, Rosario, , Argentina
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica, San Juan, , Argentina
Clinica Viedma S.A., Viedma, , Argentina
Campbelltown Hospital; Macarthur Cancer Therapy Centre, Campbelltown, New South Wales, Australia
Coffs Harbour Health Campus, Coffs Harbour, New South Wales, Australia
Concord Repatriation General Hospital; Concord Cancer Centre, Concord, New South Wales, Australia
Kinghorn Cancer Centre; St Vincents Hospital, Darlinghurst, New South Wales, Australia
Gosford Hospital; Cancer Care Services, Gosford, New South Wales, Australia
Icon Cancer Care Wesley, Auchenflower, Queensland, Australia
University of the Sunshine Coast, Sippy Downs, Queensland, Australia
Bendigo Cancer Centre, Bendigo, Victoria, Australia
Sir Charles Gairdner Hospital; Medical Oncology, Perth, Western Australia, Australia
Cliniques Universitaires St-Luc, Bruxelles, , Belgium
GHdC Site Notre Dame, Charleroi, , Belgium
UZ Antwerpen, Edegem, , Belgium
UZ Gent, Gent, , Belgium
UZ Leuven Gasthuisberg, Leuven, , Belgium
Clinique Ste-Elisabeth, Namur, , Belgium
Hospital da Bahia, Salvador, BA, Brazil
Instituto D?Or de Pesquisa e Ensino ? Hospital DF STAR, Brasilia, DF, Brazil
NUPEC, Belo Horizonte, MG, Brazil
Hospital do Cancer de Pernambuco - HCP, Recife, PE, Brazil
Instituto D?Or de Pesquisa e Ensino ? Hospital Esperança Recife, Recife, PE, Brazil
Hospital Santa Cruz / Centro de Oncologia D'Or, Curitiba, PR, Brazil
Liga Norte Riograndense Contra O Câncer, Natal, RN, Brazil
Santa Casa de Misericordia de Porto Alegre, Porto Alegre, RS, Brazil
Hospital Sao Lucas - PUCRS, Porto Alegre, RS, Brazil
Hospital de Base de Sao Jose do Rio Preto, Sao Jose do Rio Preto, SP, Brazil
Hospital Sírio-Libanês, Sao Paulo, SP, Brazil
Tom Baker Cancer Centre-Calgary, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
BC Cancer ? Vancouver, Vancouver, British Columbia, Canada
The Moncton Hospital, Moncton, New Brunswick, Canada
Juravinski Hospital, Hamilton, Ontario, Canada
The Ottawa Hospital - General Campus, Ottawa, Ontario, Canada
CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont, Montreal, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM), Montreal, Quebec, Canada
Jewish General Hospital, Montreal, Quebec, Canada
Hôpital du Sacré-Coeur de Montreal, Montreal, Quebec, Canada
The First Hospital of Jilin University, Changchun City, , China
Sichuan Provincial Cancer Hospital, Chengdu, , China
The First Affiliated Hospital, Chongqing Medical University, Chongqing, , China
Guangdong Provincial People's Hospital; Breast, Guangzhou City, , China
Sun yat-sen University Cancer Center; Internal Medicine of Oncology, Guangzhou, , China
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou City, , China
Sir Run Run Shaw Hospital Zhejiang University, Hangzhou City, , China
Harbin Medical University Tumor Hospital; Department of Surgery; Pharmacy, Harbin, , China
Shandong Cancer Hospital, Jinan, , China
The Second Affiliated Hospital to Nanchang University, Nanchang, , China
Jiangsu Cancer Hospital, Nanjing 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
First Affiliated Hospital of Medical College of Xi'an Jiaotong University, Xi'an, , China
Zhejiang Cancer Hospital, Zhejiang, , China
A.O. S. Anna e San Sebastiano; Oncologia, Caserta, Campania, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica, Meldola, Emilia-Romagna, Italy
AUSL della Romagna; Dipartimento Oncoematologico - U.O.C. Oncologia, Ravenna, Emilia-Romagna, Italy
Irccs Centro Di Riferimento Oncologico (CRO), Aviano, Friuli-Venezia Giulia, Italy
Ospedale San Raffaele; Medical Oncology, Milano, Lombardia, Italy
AOU Città della Salute e della Scienza di Torino, Torino, Piemonte, Italy
Humanitas Centro Catanese Di Oncologia; Oncologia Medica, Misterbianco (CT), Sicilia, Italy
Ospedale S. Giuseppe; Oncologia, Empoli (FI), Toscana, Italy
Ospedale Santa Chiara; Oncologia Medica, Trento, Trentino-Alto Adige, Italy
Kyungpook National University Chilgok Hospital, Daegu, , Korea, Republic of
National Cancer Center, Goyang-si, , Korea, Republic of
CHA Bundang Medical Center, Gyeonggi-do, , Korea, Republic of
Catholic Univ. of Incheon St.Mary's Hospital, Incheon, , Korea, Republic of
Inha University Hospital, Incheon, , Korea, Republic of
Korea University Anam Hospital, Seoul, , 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
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara, Jalisco, Mexico
Panamerican Clinical Research S.A de C.V., Guadalajara, Jalisco, Mexico
RENATI INNOVATION S.A.P.I. de C.V, Guadalajara, Jalisco, Mexico
Health Pharma Professional Research, Cdmx, Mexico CITY (federal District), Mexico
COI Centro Oncologico Internacional Santa Fe, Ciudad de México, Mexico CITY (federal District), Mexico
OncoMed; Supportive Care, Ciudad de México, Mexico CITY (federal District), Mexico
ARKE Estudios Clínicos S.A. de C.V., Ciudad de México, , Mexico
CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO, Mexico City, , Mexico
Instituto Nacional de Cancerologia; Oncology, Mexico City, , Mexico
Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Ambulatorium Chemioterapii, Bydgoszcz, , Poland
Szpital Morski im.PCK; Oddzial Onkologii Klinicznej, Oddzial Dzienny, Gdynia, , Poland
Narodowy Instytut Onkologii Odzia? w Gliwicach; Centrum Diagnostyki i Leczenia Chorób Piersi, Gliwice, , Poland
Przychodnia Lekarska KOMED, Roman Karaszewski, Konin, , Poland
Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii, Koszalin, , Poland
Szpital Uniwersytecki w Krakowie; Oddzial Kliniczny Onkologii i Poradnia Onkologiczna, Kraków, , Poland
MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie, Rzeszow, , Poland
Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Nowotworow Piersi i Chirurgii Rekonstr, Warszawa, , Poland
Richards Bay Oncology Centre, KwaZulu Natal, , South Africa
ICO L'Hospitalet; Servicio de oncologia medica, L'Hospitalet de Llobregat, Barcelona, Spain
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia, Santiago de Compostela, LA Coruña, Spain
Hospital Universitario de Canarias;servicio de Oncologia, La Laguna, Tenerife, Spain
Hospital Universitari Vall d'Hebron; Oncology, Barcelona, , Spain
Hospital San Pedro De Alcantara; Servicio de Oncologia, Caceres, , 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 Regional Universitario Carlos Haya; Servicio de Oncologia, Malaga, , Spain
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia, Murcia, , Spain
Hospital Universitario Virgen Macarena; Servicio de Oncologia, Sevilla, , Spain
China Medical University Hospital; Surgery, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
Taipei Veterans General Hospital, Taipei City, , Taiwan
Chang Gung Memorial Hosipital at Linkou, Taoyuan City, , Taiwan
Veterans General Hospital - Taichung, Xitun Dist., , Taiwan
National Taiwan University Hospital; Oncology, Zhongzheng Dist., , Taiwan
Songklanagarind Hospital; Department of Oncology, Songkhla, , Thailand
Gulhane Training and Applicaton Hospital, Ankara, , Turkey
Memorial Ankara Hastanesi, Ankara, , Turkey
Dicle University Faculty of Medicine, Diyarbakir, , Turkey
Trakya University Medical Faculty, Edirne, , Turkey
Medipol Mega Üniversite Hastanesi Göztepe, Istanbul, , Turkey
Marmara Uni Faculty of Medicine; Medical Oncology, Istanbul, , Turkey
Ege Uni Medical Faculty Hospital; Oncology Dept, Izmir, , Turkey
Katip Celebi University Ataturk Training and Research Hospital; Oncology, Izmir, , Turkey
Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology, Kadiköy, , Turkey
Medical Park Seyhan Hospital; Oncology Department, Seyhan, , Turkey
Hacettepe Uni Medical Faculty Hospital; Oncology Dept, Sihhiye/Ankara, , Turkey
Basingstoke and North Hampshire Hospital, Basingstoke, , United Kingdom
Blackpool Victoria Hospital, Blackpool, , United Kingdom
Dumfries and Galloway Royal Infirmary, Dumfries, , United Kingdom
Western General Hospital; Clinical Oncology, Edinburgh, , United Kingdom
Princess Alexandra Hospital, Harlow, , United Kingdom
St John's Hospital, Livingston, , United Kingdom
St Bartholomew's Hospital, London, , United Kingdom
Maidstone & Tonbridge Wells Hospital; Kent Oncology Center, Maidstone, , United Kingdom
Mount Vernon & Watford Trust Hospital; Dept. of Clinical Oncology, Northwood, , United Kingdom
Churchill Hospital; Department of Oncology, Oxford, , United Kingdom
Royal Preston Hosptial, Preston, , United Kingdom
ROYAL HAMPSHIRE COUNTY HOSPITAL; R&D Office, Winchester, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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