Spots Global Cancer Trial Database for 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)
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Trial Identification
Brief Title: 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)
Official Title: A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Giredestrant in Combination With Phesgo Versus Phesgo After Induction Therapy With Phesgo + Taxane in Patients With Previously Untreated HER2-Positive, Estrogen Receptor-Positive Locally-Advanced or Metastatic Breast Cancer
Study ID: NCT05296798
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Genesis Cancer Center, Hot Springs, Arkansas, United States
Los Angeles Hematology Oncology Medical Group, Los Angeles, California, United States
St Mary's Hospital and Medical Center, Grand Junction, Colorado, United States
Cancer Specialists of North Florida, Jacksonville, Florida, United States
Florida Cancer Specialists - EAST - SCRI - PPDS, West Palm Beach, Florida, United States
Maryland Oncology Hematology - Annapolis, Annapolis, Maryland, United States
Swedish Cancer Institute, Cary, North Carolina, United States
Hightower Clinical, Oklahoma City, Oklahoma, United States
West Cancer Center, Germantown, Tennessee, United States
Texas Oncology - Austin, Austin, Texas, United States
Texas Oncology - DFW, Dallas, Texas, United States
Texas Oncology - El Paso, El Paso, Texas, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Swedish Cancer Institute - Edmonds Campus, Edmonds, Washington, United States
Swedish Cancer Institute - Issaquah, Issaquah, Washington, United States
Fundación CENIT para la Investigación en Neurociencias, Buenos Aires, , Argentina
Centro Oncologico Korben; Oncology, Ciudad Autonoma Buenos Aires, , Argentina
Centro Oncologico Riojano Integral (CORI), La Rioja, , Argentina
Fundacion Scherbovsky, Mendoza, , 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
Cliniques Universitaires St-Luc, Bruxelles, , Belgium
GHdC Site Notre Dame, Charleroi, , Belgium
UZ Gent, Gent, , Belgium
Jessa Zkh (Campus Virga Jesse), Hasselt, , Belgium
UZ Leuven Gasthuisberg, Leuven, , Belgium
Clinique Ste-Elisabeth, Namur, , Belgium
Hospital Sao Rafael - HSR, Salvador, BA, Brazil
Pronutrir - suporte nutricional e quimioterapia ltda., Fortaleza, CE, Brazil
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
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda, Ijui, RS, Brazil
Hospital Nossa Senhora da Conceicao, Porto Alegre, RS, Brazil
Fundação Pio XII Hospital de Câncer 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
Affiliated Hospital of Hebei University; Department of medical oncology, Baoding, , China
Peking University People's Hospital, Beijing, , China
the First Affiliated Hospital of Bengbu Medical College, Bengbu City, , China
The First Hospital of Jilin University, Changchun City, , China
Hunan Cancer Hospital, Changsha CITY, , China
Sichuan Cancer Hospital, Chengdu City, , China
West China Hospital - Sichuan University, Chengdu City, , China
No. 900 Hospital (Fuzhou General Hospital), Fuzhou City, , China
Fujian Cancer Hospital, Fuzhou, , China
Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department, Hangzhou City, , China
Zhejiang Provincial People?s Hospital, Hangzhou, , China
Shandong Cancer Hospital, Jinan, , China
The First Affiliated Hospital Of Jinzhou Medical University, Jinzhou City, , China
Yunnan Cancer Hospital, Kunming, , China
The Third Hospital of Nanchang, Nanchang City, , China
Jiangxi Cancer Hospital, Nanchang City, , China
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University), Nanjing City, , China
Jiangsu Cancer Hospital, Nanjing City, , China
Guangxi Cancer Hospital of Guangxi Medical University, Nanning City, , China
Liaoning Provincial Cancer Hospital, Shengyang, , China
The First Affiliated Hospital of China Medical University, Shenyang City, , China
Tianjin Cancer Hospital, Tianjin, , China
The Tumor Hospital of Xinjiang Medical University, Urumqi, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan City, , China
The First Affiliated Hospital of Xian Jiao Tong University, Xi'an City, , China
Clinica De La Costa, Barranquilla, , Colombia
Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo, Bogota, D.C., , Colombia
Clinica Colsanitas S.A. sede Clinica Universitaria Colombia, Bogota, D.C., , Colombia
Oncomedica S.A., Monteria, , Colombia
Oncólogos de Occidente, Pereira, , Colombia
Institut Sainte Catherine;Recherche Clinique, Avignon, , France
CH de la Côte Basque - Hôpital de Bayonne, Bayonne, , France
CHU Besançon - Hôpital Jean Minjoz, Besançon Cedex, , France
Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie, Bordeaux, , France
CHU de GRENOBLE, Grenoble, , France
CHD Vendée, La Roche Sur Yon, , France
Hopital Prive Jean Mermoz, Lyon, , France
INSTITUT CURIE_Site Paris, Paris, , France
Centre Catalan D' Oncologie, Perpignan, , France
Gesundheitszentrum Wetterau, Hochwaldkrankenhaus Bad Nauheim; Gynäkologie/ onkolog. Tagesklinik, Bad Nauheim, , Germany
Sozialstiftung Bamberg, Klinikum am Bruderwald, Gynäkologie, Bamberg, , Germany
Onkologische Schwerpunktpraxis Kurfürstendamm, Berlin, , Germany
Gynäkologisches Zentrum Bonn, Bonn, , Germany
Onkozentrum Dres. Göhler, Dresden, , Germany
Kliniken Essen-Mitte, Essen, , Germany
Universitätsklinikum Freiburg; Frauenklinik, Freiburg, , Germany
HOPA MVZ GmbH, Hamburg, , Germany
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg, Heidelberg, , Germany
Ärztehaus am Bahnhofsplatz; Praxis Uleer/Pourfard, Hildesheim, , Germany
Universitätsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe, Homburg/Saar, , Germany
Dres. Andreas Köhler und Roswitha Fuchs, Langen, , Germany
Studienzentrum Onkologie Ravensburg GbR; Onkologie Ravensburg, Ravensburg, , Germany
Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie, Trier, , Germany
Budapesti Szent Margit Korhaz; Onkologia Osztaly, Budapest, , Hungary
Eszak-Pesti Centrumkorhaz - Honvedkorhaz; Podmaniczky utcai telephely, Budapest, , Hungary
Bekes Varmegyei Központi Korhaz, Pandy Kalman Tagkorhaz; Onkologiai Központ, Gyula, , Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz; Onkologiai Osztaly, Kaposvár, , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet; Megyei Onkologiai Kozpont, Szolnok, , Hungary
Komarom-Eszergom Varmegyei Szent Borbala Korhaz; Onkologiai Osztaly, Tatabanya, , Hungary
Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology, New Delhi, Delhi, India
Fortis Hospital, New Delhi, Delhi, India
Manipal Hospital; Department of Oncology, Bangalore, Karnataka, India
Tata Memorial Hospital; Dept of Medical Oncology, Mumbai, Maharashtra, India
Sahyadri Super Specialty Hospital Hadapsar, Pune, Maharashtra, India
TATA Medical Centre; Medical Oncology, Kolkata, WEST Bengal, India
Azienda Ospedaliera Universitaria Federico II, Napoli, Campania, Italy
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica, Napoli, Campania, Italy
AUSL della Romagna; Dipartimento Oncoematologico - U.O.C. Oncologia, Ravenna, Emilia-Romagna, Italy
Azienda Unità Sanitaria Locale di Reggio Emilia/IRCCS, Reggio Emilia, Emilia-Romagna, Italy
Ospedale Infermi AUSL della Romagna; U.O Operativa di Oncologia, Rimini, Emilia-Romagna, Italy
Policlinico Universitario Agostino Gemelli, Roma, Lazio, Italy
ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica, Brescia, Lombardia, Italy
Istituto Europeo Di Oncologia, Milano, Lombardia, Italy
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia, Rozzano, Lombardia, Italy
Humanitas Centro Catanese Di Oncologia; Oncologia Medica, Misterbianco (CT), Sicilia, Italy
Ospedale Civile; Unita Operativa Di Oncologia Medica, Livorno, Toscana, Italy
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II, Padova, Veneto, Italy
Azienda ULSS 8 Berica; Oncologia Medica - Ospedlae di Vicenza, Vicenza, Veneto, Italy
King Hussein Cancer Center, Amman, , Jordan
International Cancer Institute (ICI), Eldoret, , Kenya
Aga Khan University Hospital, Nairobi, , Kenya
Kyungpook National University Chilgok Hospital, Daegu, , Korea, Republic of
National Cancer Center, Goyang-si, , 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
Rizk Hospital, Beirut, , Lebanon
Investigacion Oncofarmaceutica, La Paz, BAJA California SUR, Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara, Jalisco, Mexico
Health Pharma Professional Research, Cdmx, Mexico CITY (federal District), Mexico
Iem-Fucam, D.f., Mexico CITY (federal District), Mexico
Filios Alta Medicina, Monterrey, Nuevo LEON, Mexico
Hospital Universitario; Dr. Jose E. Gonzalez, Monterrey, Nuevo LEON, Mexico
Hospital Zambrano Hellion TecSalud, Monterrey, Nuevo LEON, Mexico
Cuidados oncologicos, Querétaro, Queretaro, Mexico
Oncologico Potosino, San Luis Potosí, SAN LUIS Potosi, Mexico
Centro Estatal de Cancerologia de Chihuahua; ONCOLOGY, Chihuahua, , Mexico
Sultan Qaboos Comprehensive Cancer Care & Research Center, Muscat, , Oman
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
Opolskie Centrum Onkologii;Oddzial Onkologii Klinicznej, Opole, , Poland
Ars Medical Sp. z o. o., Pi?a, , Poland
Szpital Kliniczny im. H.Swiecickiego UM w Poznaniu, Pozna?, , Poland
MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie, Rzeszow, , Poland
Centrum Onkologii ? Instytut im. Marii Sk?odowskiej-Curie Klinika Nowotworów Piersi i Chirurgii, Warszawa, , Poland
IPO de Coimbra; Servico de Oncologia Medica, Coimbra, , Portugal
Hospital de S. Francisco Xavier; Unidade de Oncologia Medica, Lisboa, , Portugal
Hospital da Luz; Departamento de Oncologia Medica, Lisboa, , Portugal
Hospital Beatriz Angelo; Departamento de Oncologia, Loures, , Portugal
IPO do Porto; Servico de Oncologia Medica, Porto, , Portugal
National Guard King Abdulaziz Medical City; Oncology, Riyadh, , Saudi Arabia
King Fahad Medical City; Gastroentrology, Riyadh, , Saudi Arabia
Hospital Univ Vall d'Hebron; Servicio de Oncologia, Sant Andreu de La Barca, 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 Clínic i Provincial; Servicio de Oncología, Barcelona, , Spain
Hospital Universitario Clínico San Cecilio; Servicio de oncologia, Granada, , Spain
Hospital Juan Ramon Jimenez;Servicio de Oncologia, Huelva, , Spain
Centro Oncologico MD Anderson Internacional; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario La Paz; Servicio de Oncologia, Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia, Malaga, , Spain
Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia, Valencia, , Spain
Hospital Universitario Miguel Servet; Servicio Oncologia, Zaragoza, , Spain
Changhua Christian Hospital; Dept of Surgery, Changhua, , Taiwan
China Medical University Hospital; Surgery, Taichung, , Taiwan
National Cheng Kung University Hospital; Oncology, Tainan, , Taiwan
National Taiwan University Hospital ; Dept of Surgery & Hepatitis Research Center, Taipei 100, , Taiwan
Taipei Veterans General Hospital Office of General Surgery, Taipei, , Taiwan
Rajavithi Hospital; Division of Medical Oncology, Bangkok, , Thailand
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
Songklanagarind Hospital; Department of Oncology, Songkhla, , Thailand
Adana Baskent University Hospital; Medical Oncology, Adana, , Turkey
Ankara Oncology Hospital; Oncology, Ankara, , Turkey
Gazi Uni Medical Faculty Hospital; Oncology Dept, Ankara, , Turkey
Ankara City Hospital; Oncology, Ankara, , Turkey
Uludag Uni Hospital; Oncology, Bursa, , Turkey
Dicle University Faculty of Medicine, Diyarbakir, , Turkey
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi, Edirne, , Turkey
Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department, Erzurum, , Turkey
Medipol University Medical Faculty; Oncology Department, Istanbul, , Turkey
Prof. Dr. Cemil Tascioglu City Hospital; Med Onc, Istanbul, , Turkey
Ege Uni Medical Faculty; Oncology Dept, Izmir, , Turkey
Katip Celebi University Ataturk Training and Research Hospital; Oncology, Izmir, , Turkey
Kocaeli University Faculty of Medicine; Medical oncology, Izmit, , Turkey
Erciyes Uni ; Medical Oncology, Kayseri, , Turkey
Antalya Memorial Hastanesi; Onkoloji, Kepez, , Turkey
Mersin City Education and Research Hospital, Mersin, , Turkey
Ondokuz Mayis Univ. Med. Fac., Samsun, , Turkey
Ac?badem Maslak Hastanesi Büyükdere, Sar?yer/?stanbul, , Turkey
Medical Park Seyhan Hospital; Oncology Department, Seyhan, , Turkey
Hacettepe Uni Medical Faculty Hospital; Oncology Dept, Sihhiye/Ankara, , Turkey
Namik Kemal Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, 100, Tekirdag, , Turkey
Karadeniz Tecnical University Medical Faculty; Oncology Department, Trabzon, , Turkey
Ac?badem Altunizade Hastanesi; Oncology, Üsküdar, , Turkey
Uganda Cancer Institute; Fred Hutchinson Cancer Research Center, Kampala, , Uganda
Burjeel Medical City-Abu Dhabi, Abu Dhabi, , United Arab Emirates
Tawam Hospital; Medical Oncology Department, Al Ain, , United Arab Emirates
Ysbyty Gwynedd Hospital, Bangor, , United Kingdom
Royal United Hospital; Oncology Department, Bath, , United Kingdom
Blackpool Victoria Hospital, Blackpool, , United Kingdom
University Hospital North Tees, Cleveland, , United Kingdom
Royal Cornwall Hospital; Dept of Clinical Oncology, Cornwall, , United Kingdom
Charing Cross Hospital; Medical Oncology., London, , United Kingdom
Maidstone Hospital; Kent Oncology Centre, Maidstone, , United Kingdom
Nottingham University Hospitals NHS Trust - City Hospital, Nottingham, , United Kingdom
Royal Preston Hosp; Rosemere Cancer Ctr, Preston, , United Kingdom
North Wales Cancer Treatment Centre, Glan Clwyd Hospital, Rhyl, , United Kingdom
Queen's Hospital; Oncology, Romford, , United Kingdom
Singleton Hospital; Cancer Institute, Swansea, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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