Spots Global Cancer Trial Database for A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)
Official Title: A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4/6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy
Study ID: NCT06065748
Study Description
Brief Summary: This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Kaiser Permanente - Harbor City, Harbor City, California, United States
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
USC Norris Cancer Center; Oncology/Hematology - Newport Beach Treatment Center, Newport Beach, California, United States
The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente, Torrance, California, United States
Rocky Mountain Cancer Centers, Denver, Colorado, United States
Georgetown University Medical Center, Washington, District of Columbia, United States
MedStar Washington Hosp Center, Washington, District of Columbia, United States
Cancer Specialists of North Florida, Jacksonville, Florida, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
New England Cancer Specialists, Scarborough, Maine, United States
Maryland Oncology Hematology, Annapolis, Maryland, United States
Frederick Health Hospital, Frederick, Maryland, United States
Astera Cancer Care East Brunswick, East Brunswick, New Jersey, United States
Asante Rogue Regional Medical Center, Medford, Oregon, United States
Ann B. Barshinger Cancer Institute, Lancaster, Pennsylvania, United States
WellSpan Oncology Research, York, Pennsylvania, United States
Avera Cancer Institute - Aberdeen, Aberdeen, South Dakota, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
West Cancer Center, Germantown, Tennessee, United States
Texas Oncology Cancer Center, Austin, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Fundación CENIT para la Investigación en Neurociencias, Buenos Aires, , Argentina
Inst. de Oncologia Angel H. Roffo ; Oncology Dept, Buenos aires, , Argentina
Centro Oncologico Korben; Oncology, Ciudad Autonoma Buenos Aires, , Argentina
Sanatorio Allende, Cordoba, , Argentina
Centro Oncologico Riojano Integral (CORI), La Rioja, , Argentina
Hospital Alemán, Recoleta, , Argentina
Instituto de Oncología de Rosario, Rosario, , Argentina
Sanatorio Parque S.A., Rosario, , Argentina
Hospital Provincial del Centenario, Rosario, , Argentina
Centro Oncológico de Excelencia, San Juan, , Argentina
Northern Beaches Hospital, Frenchs Forest, New South Wales, Australia
Nepean Hospital; Nepean Cancer Care Centre, Kingswood, New South Wales, Australia
Mater Hospital; Patricia Ritchie Centre for Cancer Care and Research, North Sydney, New South Wales, Australia
University of the Sunshine Coast, Sippy Downs, Queensland, Australia
Mater Misericordiae Limited, South Brisbane, Queensland, Australia
Cancer Research SA, Adelaide, South Australia, Australia
Barwon Health, Geelong, Victoria, Australia
Sunshine Hospital, St Albans, Victoria, Australia
South West Healthcare, Warrnambool, Victoria, Australia
Cliniques Universitaires St-Luc, Bruxelles, , Belgium
UZ Gent, Gent, , Belgium
UZ Leuven Gasthuisberg, Leuven, , Belgium
CHU Sart-Tilman, Liège, , Belgium
Clinique Ste-Elisabeth, Namur, , Belgium
Sint Augustinus Wilrijk, Wilrijk, , Belgium
Obras Sociais Irma Dulce - Osid, Salvador, BA, Brazil
Crio - Centro Regional Integrado de Oncologia, Fortaleza, CE, Brazil
CEDOES - Diagnóstico e Pesquisa, Vitoria, ES, Brazil
Hospital Araujo Jorge; Departamento de Ginecologia E Mama, Goiania, GO, Brazil
Hospital do Cancer de Pernambuco - HCP, Recife, PE, Brazil
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda, Ijui, RS, Brazil
Santa Casa de Misericordia de Porto Alegre, Porto Alegre, RS, Brazil
Hospital Moinhos de Vento, Porto Alegre, RS, Brazil
Hospital Sao Lucas - PUCRS, Porto Alegre, RS, Brazil
Hospital de Cancer de Barretos, Barretos, SP, Brazil
Hospital Amaral Carvalho, Jau, SP, Brazil
Hospital Sírio-Libanês, Sao Paulo, SP, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda, Sao Paulo, SP, Brazil
Hospital A. C. Camargo; Oncologia, Sao Paulo, SP, Brazil
Royal Victoria Regional Health Centre, Barrie, Ontario, Canada
Lakeridge Health Oshawa, Oshawa, Ontario, Canada
North York General Hospital, Toronto, Ontario, Canada
Princess Margaret Cancer Center, Toronto, Ontario, Canada
CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital, Chicoutimi, Quebec, Canada
CISSS Chaudière-Appalaches, Levis, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM), Montreal, Quebec, Canada
McGill University Health Centre - Glen Site, Montreal, Quebec, Canada
CHU de Québec - Hôpital du Saint-Sacrement, Quebec City, Quebec, Canada
Hopital regional de saint jerome, Saint-jerome, Quebec, Canada
Clínica Puerto Montt, Puerto Montt, , Chile
Oncovida, Santiago, , Chile
Centro De Cancer Universidad Catolica, Santiago, , Chile
Icegclinic, Santiago, , Chile
Beijing Cancer Hospital, Beijing, , China
the First Hospital of Jilin University; Cancer Center, Changchun City, , China
Hunan Cancer Hospital, Changsha CITY, , China
West China Hospital of Sichuan University, Chengdu City, , China
Sichuan Provincial People's Hospital, Chengdu, , China
The First Affiliated Hospital, Chongqing Medical University, Chongqing, , China
Fujian Medical University Union Hospital, Fuzhou City, , China
No. 900 Hospital (Fuzhou General Hospital), Fuzhou City, , China
Cancer Center, Sun Yat-sen University of Medical Sciences; Department of Medical Oncology, Guangzhou City, , China
The Second Affiliated Hospital of Zhejiang University College, Hangzhou, , China
Harbin Medical University Cancer Hospital, Harbin, , China
Jinan Central Hospital, Jinan City, , China
Shandong Cancer Hospital, Jinan, , China
The First People's Hospital of Yunnan Province, Kunming City, , China
The First Affiliated Hospital to Henan University of Science and Technology, Luoyang City, , China
Guangxi Cancer Hospital of Guangxi Medical University, Nanning City, , China
Fudan University Shanghai Cancer Center, Shanghai City, , China
Shanxi Province Cancer Hospital, Taiyuan City, , China
Taizhou Hospital of Zhejiang Province, Taizhou, , China
Tianjin Cancer Hospital; Department of Breast Oncology, 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
Hubei Cancer Hospital, Wuhan, , China
The Second Affiliated Hospital of Xi'an Jiao Tong University, Xi'an City, , China
Xi'an International Medical Center Hospital, Xian, , China
The Affiliated Hospital of Xuzhou Medical University, Xuzhou, , China
Zhejiang Cancer Hospital, Zhejiang, , China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, , China
Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo, Bogota, D.C., , Colombia
Oncomedica S.A., Monteria, , Colombia
Sociedad de Oncología y hematología del Cesar Ltda, Valledupar, , Colombia
Clinica CIMCA, San José, , Costa Rica
ICIMED Instituto de Investigación en Ciencias Médicas, San José, , Costa Rica
Proclinical Pharma, San José, , Costa Rica
Institut Sainte Catherine, Avignon, , France
HOPITAL JEAN MINJOZ; Oncologie, Besancon, , France
Centre Francois Baclesse; Comite Sein, Caen, , France
Centre Hospitalier Saint Louis; Oncologie Medicale, La Rochelle, , France
Centre Leon Berard; Departement Oncologie Medicale, Lyon, , France
Centre Cancerologie Grand Montpellier, Montpellier, , France
Institut Jean Godinot; Oncologie Medicale, Reims CEDEX, , France
IUCT Oncopole, Toulouse, , France
Gustave Roussy, Villejuif, , France
St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe, Koeln, , Germany
Celan S.A., Ciudad de Guatemala, , Guatemala
INTEGRA Cancer Institute, Ciudad de Guatemala, , Guatemala
Sanatorio MEDIK-Cayala, Ciudad de Guatemala, , Guatemala
Grupo Angeles, Guatemala City, , Guatemala
Oncomedica, Guatemala, , Guatemala
Centro Medico Integral de Cancerologia CEMIC, Quetzaltenango, , Guatemala
Queen Mary Hospital; Dept of Medicine, Hong Kong, , Hong Kong
B-A-Z Vármegyei Központi Kórház és Egyetemi Oktatókórház; Klin. Onkológiai és Sugárterápiás Centrum, Miskolc, , Hungary
Nograd Varmegyei Szent Lazar Korhaz; Onkologiai es Sugarterapias Centrum, Salgótarján, , Hungary
MVR Cancer Centre and Research Institute, Kozhikode, Kerala, India
Grant Medical Foundation, Ruby Hall Clinic, Pune, Maharashtra, India
Hadassah Ein Karem Hospital; Oncology Dept, Jerusalem, , Israel
Rabin Medical Center; Oncology Dept, Petah Tikva, , Israel
Sheba MC, Ramat Gan, , Israel
Sourasky Medical Center; Oncology Department, Tel-Aviv, , Israel
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati, Avellino, Campania, Italy
Policlinico S.Orsola-Malpighi; Istituto Oncologia R. Addarii, Bologna, Emilia-Romagna, Italy
I.R.S.T Srl IRCCS; Oncologia Medica, Meldola, Emilia-Romagna, Italy
A.O. Universitaria Di Parma, Parma, Emilia-Romagna, Italy
RCCS - Centro di Riferimento; Oncologia Medica B, Aviano (PN), Friuli-Venezia Giulia, Italy
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia, Udine, Friuli-Venezia Giulia, Italy
Policlinico Universitario Agostino Gemelli, Roma, Lazio, Italy
Università Campus Bio-Medico di Roma; Oncologia Medica, Roma, Lazio, Italy
ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica, Brescia, Lombardia, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1, Milano, Lombardia, Italy
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia, Rozzano, Lombardia, Italy
A.O.U. Maggiore della Carità, Novara, Piemonte, Italy
Presidio Ospedaliero di Summa-Perrino; Oncologia Medica, Brindisi, Puglia, Italy
Humanitas Centro Catanese Di Oncologia; Oncologia Medica, Misterbianco (CT), Sicilia, Italy
Azienda Ospedaliera Universitaria Careggi, Florence, Toscana, Italy
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II, Padova, Veneto, Italy
Kyungpook National University Chilgok Hospital, Daegu, , 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; Clinical Pharmacy, 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
Ulsan University Hosiptal, Ulsan, , Korea, Republic of
Palmerston North Hospital; Regional Cancer Treatment Service, Palmerston North, , New Zealand
Instytut "Centrum Zdrowia Matki Polki"; Klinika Onkologii, ?ód?, , Poland
Szpital Morski Im. Pck; Oncology & Radiotherapy Dept, Gdynia, , Poland
?wi?tokrzyskie Centrum Onkologii; Dzia? Chemioterapii, Kielce, , Poland
Przychodnia Lekarska KOMED, Roman Karaszewski, Konin, , Poland
Mazowiecki Szpital Wojewódzki im. ?w. Jana Paw?a II; Oddzial Onkologii Klinicznej i Radioterapii, Siedlce, , Poland
Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych, Szczecin, , 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
IPO do Porto; Servico de Oncologia Medica, Porto, , Portugal
CHVNG/E_Unidade 1; Servico de Oncologia Medica, Vila Nova de Gaia, , Portugal
Institut Catala d?Oncologia Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia, Sant Andreu de La Barca, Barcelona, Spain
Hospital de Jerez de la Frontera; Servicio de Oncologia, Jerez de La Frontera, Cadiz, Spain
Hospital Quiron de Madrid; Servicio de Oncologia, Pozuelo de Alarcon, Madrid, Spain
Hospital Universitario Virgen de La Arrixaca; Servicio De Oncologia, El Palmar, Murcia, Spain
Hospital Alvaro Cunqueiro; Servicio de Oncologia, Vigo, Pontevedra, Spain
Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica, Barcelona, , Spain
Hospital Juan Ramon Jimenez;Servicio de Oncologia, Huelva, , Spain
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia, Jaen, , Spain
Centro Oncologico MD Anderson Internacional; Servicio de Oncologia, Madrid, , Spain
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario Virgen Macarena; Servicio de Oncologia, Sevilla, , Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia, Sevilla, , Spain
Instituto Valenciano Oncologia; Oncologia Medica, Valencia, , Spain
Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia, Valencia, , Spain
Hsin-Chu Branch of National Taiwan University Hospital, Hsinchu City, , Taiwan
China Medical University Hospital; Surgery, Taichung, , 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; Dept of Oncology, Taipei, , Taiwan
Veterans General Hospital - Taichung, Xitun Dist., , Taiwan
Maharaj Nakorn Chiang Mai Hospital; Depart of Radiology; Divis of Therapeutic Radiology and Oncology, Muang Chiang MAI Delivery Branch 3, , Thailand
Songklanagarind Hospital; Department of Oncology, Songkhla, , Thailand
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
