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Brief Title: The XENERA™ 1 Study Tests Xentuzumab in Combination With Everolimus and Exemestane in Women With Hormone Receptor Positive and HER2-negative Breast Cancer That Has Spread
Official Title: XENERA™1: A Multi-centre, Double-blind, Placebo-controlled, Randomised Phase II Trial to Compare Efficacy of Xentuzumab in Combination With Everolimus and Exemestane Versus Everolimus and Exemestane in Women With HR+ / HER2- Metastatic Breast Cancer and Non-visceral Disease
Study ID: NCT03659136
Brief Summary: The main objective of the trial is to assess the efficacy of xentuzumab in combination with everolimus and exemestane over everolimus and exemestane in patients with HR+/ HER2- advanced or metastatic breast cancer and non-visceral disease.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Ironwood Cancer and Research Centers, Chandler, Arizona, United States
Cancer Treatment Centers of America at Western Regional Medical Center, Goodyear, Arizona, United States
Beverly Hills Cancer Center, Beverly Hills, California, United States
University of California San Francisco, San Francisco, California, United States
Yale Cancer Center, New Haven, Connecticut, United States
Florida Cancer Specialists, Fort Myers, Florida, United States
University Cancer and Blood Center, Athens, Georgia, United States
Hematology Oncology of Indiana, Indianapolis, Indiana, United States
University of Minnesota, Minneapolis, Minnesota, United States
HCA MidAmerica Division, Inc., Kansas City, Missouri, United States
Hematology Oncology Associates of Rockland, Nyack, New York, United States
Southwestern Regional Medical Center, Tulsa, Oklahoma, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
The Center for Cancer and Blood Disorders, Fort Worth, Texas, United States
Utah Cancer Specialists Cancer Center, Salt Lake City, Utah, United States
Northwest Medical Specialties, PLLC, Tacoma, Washington, United States
The Tweed Hospital, Tweed Heads, New South Wales, Australia
Peninsula Haematology & Oncology, Frankston, Victoria, Australia
Brussels - UNIV Saint-Luc, Bruxelles, , Belgium
Brussels - UNIV UZ Brussel, Jette, , Belgium
Kortrijk - HOSP AZ Groeninge Kennedylaan, Kortrijk, , Belgium
UZ Leuven, Leuven, , Belgium
CHU de Quebec-Universite Laval Research Centre, Quebec, , Canada
INS Sainte Catherine, Avignon, , France
HOP Victor Hugo, Le Mans, , France
INS Paoli-Calmettes, Marseille, , France
INS Curie, Paris, , France
HOP Européen G. Pompidou, Paris, , France
HOP Lyon Sud, Pierre Benite, , France
INS Claudius Regaud IUCT-Oncopole, Toulouse, , France
Universitätsklinikum Erlangen, Erlangen, , Germany
Vincentius-Diakonissen-Kliniken gAG, Karlsruhe, , Germany
General Hospital of Athens "Alexandra", Athens, , Greece
University General Hospital of Heraklion, Heraklion, , Greece
University Hospital of Larisa, Oncology Clinic, Larisa, , Greece
Metropolitan Hospital, Oncology Clinic, Neo Faliro, Athens, , Greece
Euromedica Kyanous Stavros General Hospital, Thessaloniki, , Greece
Istituto Nazionale IRCCS Tumori Fondazione Pascale, Napoli, , Italy
Iov, Irccs, Padova, , Italy
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza, Roma, , Italy
Fundação Champalimaud,, Lisboa, , Portugal
Hospital Beatriz Ângelo, Loures, , Portugal
Centro Hospitalar de Vila Nova de Gaia, Vila Nova de Gaia, , Portugal
Hospital Teresa Herrera, A Coruña, , Spain
Hospital Clínic de Barcelona, Barcelona, , Spain
Hospital Arnau de Vilanova, Lleida, , Spain
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
Hospital Ramón y Cajal, Madrid, , Spain
Hospital Clínico San Carlos, Madrid, , Spain
Hospital Regional Universitario de Málaga, Málaga, , Spain
Instituto Valenciano de Oncología, Valencia, , Spain
Clínica Quirón de Valencia, Valencia, , Spain
Hospital Clínico de Valencia, Valencia, , Spain
St Bartholomew's Hospital, London, , United Kingdom