Spots Global Cancer Trial Database for A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer
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Trial Identification
Brief Title: A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer
Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer
Study ID: NCT04191499
Conditions
Study Description
Brief Summary: This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Beverly Hills Cancer Center, Beverly Hills, California, United States
Florida Cancer Specialists (St. Petersburg ? St. Anthony?s Professional Building), Saint Petersburg, Florida, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
Massachusetts General Hospital., Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina, United States
Sarah Cannon Research Institute / Tennessee Oncology, Chattanooga, Tennessee, United States
Tennessee Oncology - Nashville, Nashville, Tennessee, United States
Texas Onc-Central Austin CA Ct, Austin, Texas, United States
Texas Tech University Health Sciences Center; Department of Internal Medicine, El Paso, Texas, United States
Texas Oncology - Northeast Texas, Tyler, Texas, United States
Northwest Medical Specialties, Tacoma, Washington, United States
Fundación CENIT para la Investigación en Neurociencias, Buenos Aires, , Argentina
Centro Oncologico Korben; Oncology, Ciudad Autonoma Buenos Aires, , Argentina
Hosp Provincial D. Centenarios; Oncology Dept, Rosario, , Argentina
Clinica Viedma S.A., Viedma, , Argentina
Macquarie University Hospital, Macquarie Park, New South Wales, Australia
Westmead Hospital; Medical Oncology and Pallative Care, Westmead, New South Wales, Australia
Southern Medical Day Care Centre, Wollongong, New South Wales, Australia
Mater Adult Hospital; Oncology, South Brisbane, Queensland, Australia
Princess Alexandra Hospital; Cancer Trials Unit, Woolloongabba, Queensland, Australia
Western Health, Fitzroy, Victoria, Australia
Peninsula and South Eastern Haematology and Oncology Group, Frankston, Victoria, Australia
UZ Leuven Gasthuisberg, Leuven, , Belgium
Hospital Araujo Jorge; Departamento de Ginecologia E Mama, Goiania, GO, Brazil
Santa Casa de Misericordia de Porto Alegre, Porto Alegre, RS, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda, Sao Paulo, SP, Brazil
Tom Baker Cancer Centre-Calgary, Calgary, Alberta, Canada
London Regional Cancer Program, London Health Sciences Centre, Baines Centre, London, Ontario, Canada
Ottawa Hospital, Ottawa, Ontario, Canada
Princess Margaret Cancer Center, Toronto, Ontario, Canada
Hopital du Saint Sacrement, Quebec City, Quebec, Canada
Beijing Cancer Hospital, Beijing, , China
The First Hospital of Jilin University, Changchun City, , China
West China Hospital, Sichuan University, Chengdu, , China
The First Affiliated Hospital, Chongqing Medical University, Chongqing, , China
Fujian Medical University Union Hospital, Fuzhou City, , China
Sun Yet-sen University Cancer Center, Guangzhou City, , China
Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department, Hangzhou City, , China
Harbin Medical University Cancer Hospital, Harbin, , China
Shandong Cancer Hospital, Jinan, , China
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University), Nanjing City, , China
Fudan University Shanghai Cancer Center; Medical Oncology, Shanghai City, , China
Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province), Shijiazhuang, , China
Tianjin Cancer Hospital, 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
Henan Cancer Hospital, Zhengzhou, , China
Vejle Sygehus; Onkologisk Afdeling, Vejle, , Denmark
Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne, Clermont-ferrand, , France
Centre Georges Francois Leclerc; Oncologie 3, Dijon, , France
Centre Oscar Lambret; Senologie, Lille, , France
Hopital Dupuytren; Oncologie Medicale, Limoges, , France
Hopital Prive Jean Mermoz; Cancerologie, Lyon, , France
Institut régional du Cancer Montpellier, Montpellier, , France
Institut Universitaire du Cancer de Toulouse-Oncopole, Toulouse, , France
Acad. F. Todua Medical Center, Tbilisi, , Georgia
Israel-Georgian Medical Research Clinic Healthycore, Tbilisi, , Georgia
Cancer Research Centre, Tbilisi, , Georgia
Tbilisi Oncology Dispensary, Tbilisi, , Georgia
Multiprofile Clinic Consilium Medulla, Tbilisi, , Georgia
S Khechinashvili University Clinic Ltd, Tbilisi, , Georgia
Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters, Berlin, , Germany
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum, Essen, , Germany
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg, Heidelberg, , Germany
Universitätsklinikum Mannheim; Frauenklinik, Mannheim, , Germany
Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie, Trier, , Germany
Universitätsfrauenklinik Ulm; Abteilung Gynäkologie, Ulm, , Germany
Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine, Athens, , Greece
Univ General Hosp Heraklion; Medical Oncology, Heraklion, , Greece
Euromedical General Clinic of Thessaloniki; Oncology Department, Thessaloniki, , Greece
Queen Mary Hospital; Dept of Medicine, Hong Kong, , Hong Kong
Prince of Wales Hospital; Department of Clinical Onocology, Shatin, , Hong Kong
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly, Budapest, , Hungary
Uzsoki Utcai Korhaz; Onkoradiológiai Osztály, Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont ; Department of Oncology, Debrecen, , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet; Megyei Onkologiai Kozpont, Szolnok, , Hungary
Azienda Ospedaliera Universitaria Federico II, Napoli, Campania, Italy
A.O. Universitaria Di Parma, Parma, Emilia-Romagna, Italy
Irccs Centro Di Riferimento Oncologico (CRO), Aviano, Friuli-Venezia Giulia, Italy
Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina, Brescia, Lombardia, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy
Ospedale Santa Maria Annunziata; Oncologia, Bagno a Ripoli, Toscana, Italy
Azienda Ospedaliero Universitaria Pisana; Unita Operativa Oncologia Medica 2, Pisa, Toscana, Italy
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II, Padova, Veneto, Italy
Pusan National University Hospital, Busan, , Korea, Republic of
Kyungpook National University Medical Center, Daegu, , Korea, Republic of
National Cancer Center, Goyang-si, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , 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
Ewha Womans University Mokdong Hospital, Seoul, , Korea, Republic of
National Cancer Institute IKN, Putrajaya, Federal Territory OF Putrajaya, Malaysia
Hospital Sultan Ismail; Oncology, Johor Bahru, Johor, Malaysia
Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care, Sarawak, , Malaysia
Palmerston North Hospital; Regional Cancer Treatment Service, Palmerston North, , New Zealand
Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna, ?ód?, , Poland
Narodowy Instytut Onkologii Odzia? w Gliwicach; Centrum Diagnostyki i Leczenia Chorób Piersi, Gliwice, , Poland
Przychodnia Lekarska KOMED, Roman Karaszewski, Konin, , Poland
Opolskie Centrum Onkologii; Onkologia Kliniczna z Odcinkiem Dziennym, Opole, , Poland
Lecznice Citomed Sp. z o.o., Torun, , Poland
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr, Warszawa, , Poland
Wojskowy Instytut Medyczny; Klinika Onkologii, Warszawa, , Poland
Centro Clinico Champalimaud; Oncologia Medica, Lisboa, , Portugal
IPO do Porto; Servico de Oncologia Medica, Porto, , Portugal
Moscow Clinical Scientific Center, Moscow, Moskovskaja Oblast, Russian Federation
Blokhin Cancer Research Center; Out-Patients Dept, Moscow, Moskovskaja Oblast, Russian Federation
MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy, Moscow, Moskovskaja Oblast, Russian Federation
LLC Medscan, Moskva, Moskovskaja Oblast, Russian Federation
Clinical Hospital Lapino (LLC Haven), Yudino, Moskovskaja Oblast, Russian Federation
Medical Clinic "AB Medical group", Sankt-peterburg, Sankt Petersburg, Russian Federation
Volgograd Regional Clinical Oncology Dispensary, Volgograd, , Russian Federation
Regional Clinical Oncology Hospital, Yaroslavl, , Russian Federation
National University Hospital; National University Cancer Institute, Singapore (NCIS), Singapore, , Singapore
National Cancer Centre; Medical Oncology, Singapore, , Singapore
Hospital General Universitario de Elche; Servicio de Oncologia, Elche, Alicante, Spain
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia, Badalona, Barcelona, Spain
Hospital Universitario Puerta de Hierro; Servicio de Oncologia, Majadahonda, Madrid, Spain
Clinica Universitaria de Navarra; Servicio de Oncologia, Pamplona, Navarra, Spain
Hospital Universitario de Canarias;servicio de Oncologia, La Laguna, Tenerife, Spain
Hospital del Mar; Servicio de Oncologia, Barcelona, , Spain
Vall d?Hebron Institute of Oncology (VHIO), Barcelona, Barcelona, , Spain
Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department, Barcelona, , Spain
Insituto Catalán de Oncologia (ICO), Barcelona, , Spain
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia, Jaen, , Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia, Madrid, , Spain
Clinica Universidad de Navarra-Madrid, Madrid, , Spain
Hospital Clinico San Carlos; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario Virgen Macarena; Servicio de Oncologia, Sevilla, , Spain
Instituto Valenciano Oncologia; Oncologia Medica, Valencia, , Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia, Valencia, , Spain
Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery, Kaohsiung, , Taiwan
Chi-Mei Medical Centre; Hematology & Oncology, Tainan, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology, Taipei City, , Taiwan
VETERANS GENERAL HOSPITAL; Department of General Surgery, Taipei, , Taiwan
National Taiwan Uni Hospital; General Surgery, Taipei, , Taiwan
Tri-Service General Hospital, Division of General Surgery, Taipei, , Taiwan
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc, Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial, Chiang Mai, , Thailand
Chulabhorn Hospital; Medical Oncology, Lak Si, , Thailand
Songklanagarind Hospital; Department of Oncology, Songkhla, , Thailand
Adana Baskent University Hospital; Medical Oncology, Adana, , Turkey
Gulhane Training and Research Hospital, Ankara, , Turkey
Ege University Medical Faculty; Medical Oncology Department, Bornova, ?zm?r, , Turkey
Istanbul University Cerrahpasa Faculty of Medicine, Istanbul, , Turkey
Prof. Dr. Cemil Tascioglu City Hospital; Med Onc, Istanbul, , Turkey
SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU; Purulent Surgery department, Kharkiv, Kharkiv Governorate, Ukraine
Municipal Institution SubCarpathian Clinical Oncological Centre; Surgical department#2, Ivano-Frankivsk, KIEV Governorate, Ukraine
Uzhhorod Central City Clinical Hospital, Uzhhorod, KIEV Governorate, Ukraine
City Clinical Hospital #4, Dnipropetrovsk, , Ukraine
ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department, Kryvyi Rih, , Ukraine
Kyiv City Clinical Oncological Center, Kyiv, , Ukraine
RCI Sumy Regional Clinical Oncological Dispensary, Sumy, , Ukraine
Bristol Royal Infirmary, Bristol, , United Kingdom
Princess Alexandra Hospital; Oncology Department, Harlow, , United Kingdom
Barts Health NHS Trust; Cancer Research Delivery Group, London, , United Kingdom
St Georges University Hospitals NHS Foundation Trust, London, , United Kingdom
Royal Marsden Hospital - Fulham; Oncology Department, London, , United Kingdom
Christie Foundation Trust, Manchester, , United Kingdom
Mount Vernon Hospital; Mount Vernon Cancer Centre, Northwood, , United Kingdom
Nottingham City Hospital, Nottingham, , United Kingdom
Churchill Hospital; Department of Oncology, Oxford, , United Kingdom
Peterborough City Hospital, Edith Cavell Campus; Oncology Department, Peterborough, , United Kingdom
Derriford Hospital, Plymouth, , United Kingdom
Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital, Portsmouth, , United Kingdom
Royal Marsden Hosp NHS Fnd; Medicine - Breast Unit, Sutton, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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