Spots Global Cancer Trial Database for A Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor (AI) Therapy
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Trial Identification
Brief Title: A Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor (AI) Therapy
Official Title: A Phase II, Open-Label, Randomized Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic ER+ /HER2- Breast Cancer Resistant to Aromatase Inhibitor Therapy
Study ID: NCT02569801
Conditions
Study Description
Brief Summary: The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of GDC-0810 compared with fulvestrant in postmenopausal women with advanced or metastatic estrogen receptor positive (ER+)/ human epidermal growth factor receptor 2 negative (HER2-) breast cancer resistant to AI therapy. The development of GDC-0810 has been halted by the Sponsor and the enrollment in this study has been discontinued. Participants currently enrolled in the study who are experiencing clinical benefit may continue receiving GDC-0810 as a single agent or fulvestrant until disease progression (PD), unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of the study by the Sponsor.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Yale Cancer Center, New Haven, Connecticut, United States
Florida Cancer Specialists-Broadway, Fort Myers, Fort Myers, Florida, United States
Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building), Saint Petersburg, Florida, United States
Oncology Hematology Care Inc, Cincinnati, Ohio, United States
Tennessee Oncology PLLC, Franklin, Tennessee, United States
The Center for Cancer and Blood Disorders - Fort Worth, Fort Worth, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia
Port Macquarie Base Hospital, Port Macquarie, New South Wales, Australia
Adelaide Cancer Centre, Kurralta Park, South Australia, Australia
Royal Hobart Hospital; Medical Oncology, Hobart, Tasmania, Australia
Footscray Hospital, Footscray, Victoria, Australia
Peninsula and South Eastern Haematology and Oncology Group, Frankston, Victoria, Australia
Epworth HealthCare; Clinical Trials Centre, Richmond, Victoria, Australia
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden, Dresden, , Germany
Universitätsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Praxisklinik für Hämatologie und Onkologie Dres. Köppler/Heymans/Weide/Thomalla, Koblenz, , Germany
HELIOS Klinikum Krefeld; Klinik für Frauenheilkunde und Geburtshilfe, Krefeld, , Germany
Rotkreuzklinikum München; Frauenklinik, Muenchen, , Germany
Universitätsklinikum Tübingen, Tuebingen, , Germany
Marien Hospital Witten Gemeinnützige GmbH, Witten, , Germany
Kyungpook National University Medical Center, Daegu, , Korea, Republic of
National Cancer Center, Goyang-si, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Ulsan University Hosiptal, Ulsan, , Korea, Republic of
Hospital Clinic, Barcelona, Cantabria, Spain
Complejo Hospitalario Universitario A Coruña; Servicio de Endocrinologia, A Coruña, LA Coruña, Spain
Hospital Universitari Arnau de Vilanova, Lleida, Lerida, Spain
Hospital del Mar, Barcelona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hosp. Clinico San Carlos, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Royal Sussex County Hospital, Brighton, , United Kingdom
Western General Hospital, Edinburgh, , United Kingdom
St Bartholomew's Hospital, London, , United Kingdom
University College Hospital, London, , United Kingdom
Sarah Cannon Research Institute, London, , United Kingdom
Macclesfield District General Hospital, Macclesfield, , United Kingdom
Nottingham City Hospital, Nottingham, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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