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Brief Title: Trial Evaluating Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer
Official Title: A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase II Trial Evaluating the Safety and Efficacy of Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer That Have Evidence of Disease Progression on or After Prior Endocrine Therapy
Study ID: NCT01528345
Brief Summary: This trial is designed to enroll postmenopausal patients with locally advanced or metastatic, HER2- and HR+ breast cancer not amenable to curative treatment by surgery or radiotherapy, and whose disease has progressed on or after prior endocrine therapy. Patients must undergo molecular pre-screening prior to entry.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Ironwood Cancer and Research Centers SC, Chandler, Arizona, United States
Highlands Oncology Group Dept of Highlands Oncology Grp, Fayetteville, Arkansas, United States
City of Hope National Medical Center COH 3, Duarte, California, United States
University of California San Diego - Moores Cancer Center Moores UCSD Cancer Ctr. SC-1, La Jolla, California, United States
Cedars Sinai Medical Center Samuel Oschin Cancer Center, Los Angeles, California, United States
H. Lee Moffitt Cancer Center & Research Institute H. Lee Moffitt SC, Tampa, Florida, United States
Oncology Specialists, SC Lutheran General Advanced Care, Park Ridge, Illinois, United States
Indiana University Health Goshen Center for Cancer SC, Goshen, Indiana, United States
Nebraska Methodist Hospital Estabrook Cancer Center, Omaha, Nebraska, United States
Saint Barnabas Medical Center CancerCenter of Saint Barnabas, Livingston, New Jersey, United States
ProHealth Care, Lake Success, New York, United States
New York Oncology Hematology, P.C. Dept. of New York Oncology. PC, Troy, New York, United States
Duke University Medical Center Duke (SC), Durham, North Carolina, United States
Cancer Centers of the Carolinas Dept. of CC of the Carolinas, Greenville, South Carolina, United States
Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2), San Antonio, Texas, United States
Virginia Cancer Specialists, PC Dept.ofFairfax SC, Fairfax, Virginia, United States
Medical Oncology Associates, PS, Spokane, Washington, United States
Wenatchee Valley Medical Center Wenatchee Valley, Wenatchee, Washington, United States
Novartis Investigative Site, Rio Negro, Viedma, Argentina
Novartis Investigative Site, Buenos Aires, , Argentina
Novartis Investigative Site, Cordoba, , Argentina
Novartis Investigative Site, Tucuman, , Argentina
Novartis Investigative Site, Salzburg, , Austria
Novartis Investigative Site, Wien, , Austria
Novartis Investigative Site, Leuven, , Belgium
Novartis Investigative Site, Wilrijk, , Belgium
Novartis Investigative Site, Salvador, BA, Brazil
Novartis Investigative Site, Londrina, PR, Brazil
Novartis Investigative Site, Porto Alegre, RS, Brazil
Novartis Investigative Site, Sao Jose do Rio Preto, SP, Brazil
Novartis Investigative Site, São Paulo, SP, Brazil
Novartis Investigative Site, Besançon cedex, , France
Novartis Investigative Site, Bordeaux, , France
Novartis Investigative Site, Lille Cedex, , France
Novartis Investigative Site, Saint-Herblain Cédex, , France
Novartis Investigative Site, Thonon-les-Bains Cedex, , France
Novartis Investigative Site, Villejuif Cedex, , France
Novartis Investigative Site, Budapest, , Hungary
Novartis Investigative Site, Budapest, , Hungary
Novartis Investigative Site, Budapest, , Hungary
Novartis Investigative Site, Debrecen, , Hungary
Novartis Investigative Site, Gyor, , Hungary
Novartis Investigative Site, Szeged, , Hungary
Novartis Investigative Site, Szolnok, , Hungary
Novartis Investigative Site, Macerata, MC, Italy
Novartis Investigative Site, Parma, PR, Italy
Novartis Investigative Site, Sondrio, SO, Italy
Novartis Investigative Site, Maastricht, , Netherlands
Novartis Investigative Site, Rotterdam, , Netherlands
Novartis Investigative Site, Surquillo, Lima, Peru
Novartis Investigative Site, Poznan, , Poland
Novartis Investigative Site, Rzeszow, , Poland
Novartis Investigative Site, Warszawa, , Poland
Novartis Investigative Site, Warszawa, , Poland
Novartis Investigative Site, Warszawa, , Poland
Novartis Investigative Site, Ryazan, Russia, Russian Federation
Novartis Investigative Site, St. Petersburg, , Russian Federation
Novartis Investigative Site, Cape Town, , South Africa
Novartis Investigative Site, Parktown, , South Africa
Novartis Investigative Site, Port Elizabeth, , South Africa
Novartis Investigative Site, Toledo, Castilla la Mancha, Spain
Novartis Investigative Site, Barcelona, Catalunya, Spain
Novartis Investigative Site, Valencia, Comunidad Valenciana, Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Niaosong Township, , Taiwan
Novartis Investigative Site, Taichung, , Taiwan
Novartis Investigative Site, Taipei, , Taiwan
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR