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Brief Title: Study of Eniluracil + 5-Fluorouracil (5-FU) + Leucovorin Versus Capecitabine in Metastatic Breast Cancer
Official Title: A Comparative, Multicenter, Open-Label, Randomized, Phase 2 Study of the Safety and Antitumor Activity of Oral Eniluracil + 5 Fluorouracil + Leucovorin Versus Capecitabine Monotherapy in Subjects With Metastatic Breast Cancer
Study ID: NCT01231802
Brief Summary: The purpose of the study is to determine if eniluracil/5-FU/leucovorin in metastatic breast cancer (MBC) may have efficacy and tolerability advantages over capecitabine monotherapy.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
The Methodist Hospital Cancer Center, Houston, Texas, United States
Arkhangelsk Regional Clinical Oncology Center, Arkhangelsk, , Russian Federation
Chelyabinsk Regional Clinical Oncology, Chelyabinsk, , Russian Federation
Clinical Oncology Center #1, Krasnodar, , Russian Federation
Leningrad Regional Oncology Center, Leningrad, , Russian Federation
Moscow Hertzen Oncology Research Institute, Moscow, , Russian Federation
Russian Oncological Research Center n.s. Blokhin, Moscow, , Russian Federation
Orenburg Regional Clinical Oncology Center, Orenburg, , Russian Federation
Pyatigorsk Oncology Center, Pyatigorsk, , Russian Federation
Republic Oncology Center, Republic of Karelia, , Russian Federation
Oncology Center No. 2 Krasnodar Regional Healthcare Dept, Sochi, , Russian Federation
City Clinical Oncology Center, St. Petersburg, , Russian Federation
Laboratory of Thoracic Oncology of Research Institute of Pulmonary at St. Petersburg State Medical University n.a. I.P. Pavlov, St. Petersburg, , Russian Federation
Road Clinical Hospital of the Russian Railways, St. Petersburg, , Russian Federation
Stavropol Regional Clinical Oncology Center, Stavropol, , Russian Federation