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Brief Title: Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.
Official Title: A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.
Study ID: NCT02000622
Brief Summary: This open label, randomised, controlled, multi-centre phase III study will assess the efficacy and safety of single agent olaparib vs standard of care based on physician's choice of capecitabine, vinorelbine or eribulin in metastatic breast cancer patients with gBRCA 1/2 mutations.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, San Diego, California, United States
Research Site, Santa Rosa, California, United States
Research Site, Whittier, California, United States
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Research Site, Washington, District of Columbia, United States
Research Site, Jacksonville, Florida, United States
Research Site, Orlando, Florida, United States
Research Site, Plantation, Florida, United States
Research Site, Columbus, Georgia, United States
Research Site, Marietta, Georgia, United States
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Research Site, Rochester, Minnesota, United States
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Research Site, Jackson, Mississippi, United States
Research Site, Columbia, Missouri, United States
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Research Site, Lebanon, New Hampshire, United States
Research Site, Commack, New York, United States
Research Site, Harrison, New York, United States
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Research Site, Rockville Centre, New York, United States
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Research Site, Cincinnati, Ohio, United States
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Research Site, Sayre, Pennsylvania, United States
Research Site, Germantown, Tennessee, United States
Research Site, Houston, Texas, United States
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Research Site, Burlington, Vermont, United States
Research Site, Plovdiv, , Bulgaria
Research Site, Plovdiv, , Bulgaria
Research Site, Sofia, , Bulgaria
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Research Site, Vratza, , Bulgaria
Research Site, Beijing, , China
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Research Site, Changchun, , China
Research Site, Changsha, , China
Research Site, Chengdu, , China
Research Site, Dalian, , China
Research Site, Guangzhou, , China
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Research Site, Harbin, , China
Research Site, Nanjing, , China
Research Site, Shanghai, , China
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Research Site, Shenyang, , China
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Research Site, Brno, , Czechia
Research Site, Olomouc, , Czechia
Research Site, Praha 2, , Czechia
Research Site, Caen Cedex, , France
Research Site, Montpellier, , France
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Research Site, Villejuif, , France
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Research Site, Nyíregyháza, , Hungary
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Research Site, Shinagawa-ku, , Japan
Research Site, Suita-city, , Japan
Research Site, Cheongju-si, , Korea, Republic of
Research Site, Daegu, , Korea, Republic of
Research Site, Incheon, , Korea, Republic of
Research Site, Seongnam-si, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
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Research Site, Estado de México, , Mexico
Research Site, Merida, , Mexico
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Research Site, San Juan del Rio, , Mexico
Research Site, Cusco, , Peru
Research Site, Lima, , Peru
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Research Site, San Borja, , Peru
Research Site, Elbląg, , Poland
Research Site, Gdańsk, , Poland
Research Site, Grzepnica, , Poland
Research Site, Tarnobrzeg, , Poland
Research Site, Warszawa, , Poland
Research Site, Warszawa, , Poland
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Research Site, Bucharest, , Romania
Research Site, Bucuresti, , Romania
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Research Site, Cluj Napoca, , Romania
Research Site, Cluj-Napoca, , Romania
Research Site, Arkhangelsk, , Russian Federation
Research Site, Ivanovo, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Omsk, , Russian Federation
Research Site, Saint Petersburg, , Russian Federation
Research Site, Saint Petersburg, , Russian Federation
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Research Site, Saransk, , Russian Federation
Research Site, St-Petersburg, , Russian Federation
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Research Site, Barcelona, , Spain
Research Site, Córdoba, , Spain
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Research Site, Madrid, , Spain
Research Site, Majadahonda, , Spain
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Research Site, Kaohsiung, , Taiwan
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Research Site, Aberdeen, , United Kingdom
Research Site, Colchester, , United Kingdom
Research Site, Coventry, , United Kingdom
Research Site, London, , United Kingdom
Research Site, Manchester, , United Kingdom
Research Site, Plymouth, , United Kingdom
Name: Mark Robson, MD
Affiliation: Memorial Sloan-Kettering Cancer Center, New York
Role: PRINCIPAL_INVESTIGATOR