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Brief Title: Combination of Oral WX-671 Plus Capecitabine vs. Capecitabine Monotherapy in First-line Her2-negative Metastatic Breast Cancer
Official Title: A Phase 2, Two-arm, Double-blind, Multi-center, Randomized Study of the Combination of Oral WX-671 Plus Capecitabine vs. Capecitabine Monotherapy in First-line Her2-negative Metastatic Breast Cancer
Study ID: NCT00615940
Brief Summary: This randomized, double-blind, placebo controlled phase II trial is studying how well capecitabine works when given in combination with WX-671 or when given alone in treating patients receiving first-line therapy for her2negative metastatic breast cancer.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Montefiore Medical Center Weiler Division Department, New York, New York, United States
Universitys Hospital Case Medical Center, Cleveland, Ohio, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
AZ Klina, Oncology Department, Brasschaat, , Belgium
Institut Jules Bordet Oncologie Médicale, Bruxelles, , Belgium
CHU de Liège, Domaine Universitaire de Sart-Tilman, Oncology Department, Liège, , Belgium
Irmandade de Misericórdia da Santa Casa de Porto Alegre, Porto Alegre, , Brazil
Instituto Nacional do Câncer - INCA, Rio de Janeiro, , Brazil
Instituto Brasileiro de Controle do Câncer - IBCC, São Paulo, , Brazil
Gemeinschaftspraxis Dr. Brudler, Dr. Heinrich, Dr. Bangerter, Augsburg, , Germany
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Uniklinik Köln, Cologne, , Germany
Universitätsklinikum Essen, Innere Klinik und Poliklinik (Tumorforschung), Essen, , Germany
Uniklinik Frankfurt, Zentrum der Frauenheilkunde und Geburtshilfe, Frankfurt/Main, , Germany
Universitätsklinikum der Martin-Luther-Universität Halle-Wittenberg, Poliklinik Gynäkologie, Halle/Saale, , Germany
Department of Obstetrics and Gynecology, Technical University, Munich, , Germany
Bethesda KH, Mönchengladbach, , Germany
Davidof Center, Rabin Medical Center, Department of Oncology, Petah Tikva, , Israel
Kaplan Medical Center, Department of Oncolocy, Rehovot, , Israel
Sheba Medical Center, Department of Oncology, Tel Hashomer, , Israel
Assaf Harofeh medical center, Department of Oncology, Zerifin, , Israel
Name: Lori Goldstein, MD
Affiliation: Dept. of Medical Oncology, Division of Medical Science, Fox Chase Cancer Center, 7701 Burholme Avenue, Philadelphia, Pennsylvania 19111, USA
Role: PRINCIPAL_INVESTIGATOR
Name: Nadia Harbeck, MD
Affiliation: Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Uniklinik Köln
Role: PRINCIPAL_INVESTIGATOR