Spots Global Cancer Trial Database for An Open-label, Randomized, Phase II Study of the Efficacy and Safety of Indisulam (E7070) in Combination With Capecitabine
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Trial Identification
Brief Title: An Open-label, Randomized, Phase II Study of the Efficacy and Safety of Indisulam (E7070) in Combination With Capecitabine
Official Title: An Open-label, Randomized, Phase II Study of the Efficacy and Safety of Indisulam (E7070) in Combination With Capecitabine Versus Capecitabine Monotherapy for the Treatment of Metastatic Breast Cancer Patients Following Prior Anthracycline and Taxane Therapy
Study ID: NCT00165880
Conditions
Interventions
Study Description
Brief Summary: The overall purpose of this study is to compare the efficacy, safety and tolerability of indisulam in combination with capecitabine (IC) versus capecitabine (C) monotherapy in patients with metastatic breast cancer who have previously been treated with an anthracycline and a taxane.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Charite Universitatsmedizin Berlin, Berlin, , Germany
Stadt Kliniken Frankfurt-Hochst, Frankfurt, , Germany
IORC Gmbh, Hamburg, , Germany
Medizinische Klinik und Poliklinik, Mainz, , Germany
Zentrum fur Innere Medizin Hamatologie / Onkologie, Stuttgart, , Germany
Ospedali Ruiniti, Bergamo, , Italy
Ospedale S. Maria Annunzialata, Firenze, , Italy
Ospedale Morgagni-Pierantoni, Forli, , Italy
IST Istituto nazionale per la Ricerca, Genova, , Italy
Palilinico Universitano, Palermo, , Italy
Azienda Ospedaliera Pisana, Pisa, , Italy
A.O. Arciospedate S. Maria Nuova, Reggio Emilia, , Italy
Ospedale San Filippo Neri, Roma, , Italy
Arkhangelsk Regional Clinical Oncology Center, Arkhangelsk, , Russian Federation
Chelyabinsk Regional Oncology Center, Chelyabinsk, , Russian Federation
Krasnodar City Oncology Center, Krasnodar, , Russian Federation
Leningrad Regional Oncology Center, Kuzmolovo, , Russian Federation
Hertzen Research Institute of Oncology, Moscow, , Russian Federation
Semashko Central Clinical Hospital, Moscow, , Russian Federation
Rostov Oncology Research Institute, Rostov-on-Don, , Russian Federation
Petrov Research Institute of Oncology, St. Petersburg, , Russian Federation
Hospital Universiatio de Guadalajara, Guadalajara, , Spain
Centro Oncologico Regional de Galicia, La Coruna, , Spain
Hospital Unicersaitario de La Princesa, Madrid, , Spain
Centro Oncologico Anderson Internacional, Madrid, , Spain
Hospital Clinico U. Virgen de la Victoria, Malaga, , Spain
Hospital Clinico Universitario Lozano Blesa, Zaragoza, , Spain
Hospital Clinico Universitario Lozano Blesa, Zaragoza, , Spain
Cookridge Hospital, Leeds, , United Kingdom
St Bartholomew's Hospital, London, , United Kingdom
Christie Hospital NHS Trust, Manchester, , United Kingdom
Mount Vernon Cancer Centre, Northwood, , United Kingdom
South West Wales Cancer Institute, Swansea, , United Kingdom
Contact Details
Name: Jantien Wanders
Affiliation: Eisai Limited
Role: STUDY_DIRECTOR
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