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Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer
Sponsor: AstraZeneca
Summary
Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy
Official title: A Randomised, Double-blind, Parallel Group, Placebo-controlled Multi-centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients With gBRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy
Key Details
Gender
All
Age Range
18 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
1836
Start Date
2014-04-22
Completion Date
2029-05-28
Last Updated
2026-02-17
Healthy Volunteers
No
Conditions
Interventions
Olaparib
Patients will be administred olaparib orally twice daily (b.i.d.) at 300 mg. Two (2) x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 ml of water
Placebo
Patients will be administred matching placebo. Two (2) tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 ml of water
Locations (698)
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Anchorage, Alabama, United States
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Anchorage, Alaska, United States
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Gilbert, Arizona, United States
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Fort Smith, Arkansas, United States
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Baldwin Park, California, United States
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Berkeley, California, United States
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Duarte, California, United States
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Fontana, California, United States
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Fresno, California, United States
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Greenbrae, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Martinez, California, United States
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Newport Beach, California, United States
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Oakland, California, United States
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Palo Alto, California, United States
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Paradise, California, United States
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Roseville, California, United States
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Roseville, California, United States
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Sacramento, California, United States
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Stockton, California, United States
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Waterbury, Connecticut, United States
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Newark, Delaware, United States
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Sylvania, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Abington, Pennsylvania, United States
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Broomall, Pennsylvania, United States
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Danville, Pennsylvania, United States
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Drexel Hill, Pennsylvania, United States
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Hazleton, Pennsylvania, United States
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Lebanon, Pennsylvania, United States
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Lewisburg, Pennsylvania, United States
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Media, Pennsylvania, United States
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Paoli, Pennsylvania, United States
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Paoli, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Phoenixville, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Reading, Pennsylvania, United States
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State College, Pennsylvania, United States
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West Reading, Pennsylvania, United States
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West Reading, Pennsylvania, United States
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Wilkes-Barre, Pennsylvania, United States
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Williamsport, Pennsylvania, United States
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Williamsport, Pennsylvania, United States
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Wynnewood, Pennsylvania, United States
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York, Pennsylvania, United States
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Anderson, South Carolina, United States
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Badalona, Spain
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Córdoba, Spain
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Madrid, Spain
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Seville, Spain
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Valencia, Spain
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Gothenburg, Sweden
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