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.
NCT ID: NCT02000622
Last Updated: 2025-08-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
302 participants
INTERVENTIONAL
2014-03-27
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
To Study Clinical Effectiveness and Safety of Olaparib Monotherapy in Metastatic Breast Cancer Patients.
NCT03286842
A Phase I, Open-Label, 2 Part Multicentre Study to Assess the Safety and Efficacy of Olaparib in Combination With Carboplatin in Patients With Advanced HER-2 Negative Breast Cancer
NCT02561832
Olaparib In Metastatic Breast Cancer
NCT03344965
PARP-inhibitor on Advanced Metastatic Breast Cancer in Germline PALB2 Mutations Carriers
NCT05232006
Testing Olaparib Either Alone or in Combination With Atezolizumab in BRCA Mutant Non-HER2-positive Breast Cancer
NCT02849496
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Olaparib
Olaparib tablet 300mg bd po
Olaparib
Patients will be administered olaparib orally twice daily (bid) 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.
Physician's choice chemotherapy
Capecitabine 2500 mg/m2 d1-14 q 21, or Vinorelbine 30 mg/m2 d1,8 q 21, or Eribulin 1.4 mg/m2 d1,8 q 21
Physician's choice chemotherapy
Investigators will declare one of the following regimens:
* Capecitabine 2500 mg/m2 po daily (divided in 2 doses) x 14 days, repeat every 21 days
* Vinorelbine 30 mg/m2 IV Day 1 and Day 8, repeat every 21 days
* Eribulin 1.4 mg/m2 IV Day 1 and Day 8, repeat every 21 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Olaparib
Patients will be administered olaparib orally twice daily (bid) 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.
Physician's choice chemotherapy
Investigators will declare one of the following regimens:
* Capecitabine 2500 mg/m2 po daily (divided in 2 doses) x 14 days, repeat every 21 days
* Vinorelbine 30 mg/m2 IV Day 1 and Day 8, repeat every 21 days
* Eribulin 1.4 mg/m2 IV Day 1 and Day 8, repeat every 21 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Histologically or cytologically confirmed breast cancer with evidence of metastatic disease.
* Prior therapy with an anthracycline and a taxane in either an adjuvant or metastatic setting.
* Prior platinum allowed as long as no breast cancer progression occurred on treatment or if given in adjuvant/neoadjuvant setting at least 12 months from last dose to study entry elapsed.
* ER/PR breast cancer positive patients must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy.
* ECOG performance status 0-1.
* Adequate bone marrow, kidney and liver function.
Exclusion Criteria
* Patients with HER2 positive disease.
* More than 2 prior lines of chemotherapy for metastatic breast cancer.
* Untreated and/or uncontrolled brain metastases.
* Prior malignancy unless curatively treated and disease-free for \> 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix, DCIS or stage I grade 1 endometrial cancer allowed.
* Known HIV (Human Immunodeficiency Virus) infection.
* Pregnant or breast-feeding women.
18 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Myriad Genetic Laboratories, Inc.
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mark Robson, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan-Kettering Cancer Center, New York
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
San Diego, California, United States
Research Site
Santa Rosa, California, United States
Research Site
Whittier, California, United States
Research Site
Denver, Colorado, United States
Research Site
New Haven, Connecticut, United States
Research Site
Washington D.C., 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
Research Site
Chicago, Illinois, United States
Research Site
Niles, Illinois, United States
Research Site
Wichita, Kansas, United States
Research Site
Lafayette, Louisiana, United States
Research Site
Boston, Massachusetts, United States
Research Site
Boston, Massachusetts, United States
Research Site
Boston, Massachusetts, United States
Research Site
Detroit, Michigan, United States
Research Site
Grand Rapids, Michigan, United States
Research Site
Rochester, Minnesota, United States
Research Site
Saint Louis Park, Minnesota, United States
Research Site
Jackson, Mississippi, United States
Research Site
Columbia, Missouri, United States
Research Site
St Louis, Missouri, United States
Research Site
Lebanon, New Hampshire, United States
Research Site
Commack, New York, United States
Research Site
Harrison, New York, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
Research Site
Rockville Centre, New York, United States
Research Site
Syracuse, New York, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Cleveland, Ohio, United States
Research Site
Cleveland, Ohio, United States
Research Site
Portland, Oregon, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Sayre, Pennsylvania, United States
Research Site
Germantown, Tennessee, United States
Research Site
Houston, Texas, United States
Research Site
Tyler, Texas, United States
Research Site
Burlington, Vermont, United States
Research Site
Plovdiv, , Bulgaria
Research Site
Plovdiv, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Varna, , Bulgaria
Research Site
Vratsa, , Bulgaria
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Changchun, , China
Research Site
Changsha, , China
Research Site
Chengdu, , China
Research Site
Dalian, , China
Research Site
Guangzhou, , China
Research Site
Hangzhou, , China
Research Site
Harbin, , China
Research Site
Nanjing, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shenyang, , China
Research Site
Tianjin, , China
Research Site
Brno, , Czechia
Research Site
Olomouc, , Czechia
Research Site
Prague, , Czechia
Research Site
Caen, , France
Research Site
Montpellier, , France
Research Site
Rouen, , France
Research Site
Strasbourg, , France
Research Site
Villejuif, , France
Research Site
Budapest, , Hungary
Research Site
Budapest, , Hungary
Research Site
Budapest, , Hungary
Research Site
Budapest, , Hungary
Research Site
Budapest, , Hungary
Research Site
Nyíregyháza, , Hungary
Research Site
Veszprém, , Hungary
Research Site
Bologna, , Italy
Research Site
Napoli, , Italy
Research Site
Padua, , Italy
Research Site
Roma, , Italy
Research Site
Roma, , Italy
Research Site
Rozzano, , Italy
Research Site
Chūōku, , Japan
Research Site
Chūōku, , Japan
Research Site
Fukuoka, , Japan
Research Site
Kagoshima, , Japan
Research Site
Nagoya, , Japan
Research Site
Osaka, , Japan
Research Site
Sapporo, , Japan
Research Site
Shinagawa-ku, , Japan
Research Site
Suita, , Japan
Research Site
Estado de México, , Mexico
Research Site
Mérida, , Mexico
Research Site
Mérida, , Mexico
Research Site
Mérida, , Mexico
Research Site
México, , Mexico
Research Site
San Juan del Río, , Mexico
Research Site
Cusco, , Peru
Research Site
Lima, , Peru
Research Site
Lima, , Peru
Research Site
Lima, , Peru
Research Site
Lima, , Peru
Research Site
Lima, , Peru
Research Site
San Borja, , Peru
Research Site
Elblag, , Poland
Research Site
Gdansk, , Poland
Research Site
Grzepnica, , Poland
Research Site
Lodz, , Poland
Research Site
Tarnobrzeg, , Poland
Research Site
Warsaw, , Poland
Research Site
Warsaw, , Poland
Research Site
Bucharest, , Romania
Research Site
Bucharest, , Romania
Research Site
Bucharest, , Romania
Research Site
Cluj-Napoca, , Romania
Research Site
Arkhangelsk, , Russia
Research Site
Ivanovo, , Russia
Research Site
Moscow, , Russia
Research Site
Omsk, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saransk, , Russia
Research Site
Yaroslavl, , Russia
Research Site
Cheongju-si, , South Korea
Research Site
Daegu, , South Korea
Research Site
Incheon, , South Korea
Research Site
Seongnam-si, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Barcelona, , Spain
Research Site
Córdoba, , Spain
Research Site
Granada, , Spain
Research Site
Madrid, , Spain
Research Site
Majadahonda, , Spain
Research Site
Oviedo, , Spain
Research Site
Seville, , Spain
Research Site
Valencia, , Spain
Research Site
Zaragoza, , Spain
Research Site
Bern, , Switzerland
Research Site
Lausanne, , Switzerland
Research Site
Zurich, , Switzerland
Research Site
Kaohsiung City, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taoyuan District, , Taiwan
Research Site
Adana, , Turkey (Türkiye)
Research Site
Ankara, , Turkey (Türkiye)
Research Site
Edirne, , Turkey (Türkiye)
Research Site
Gaziantep, , Turkey (Türkiye)
Research Site
Istanbul, , Turkey (Türkiye)
Research Site
Izmir, , Turkey (Türkiye)
Research Site
Kayseri, , Turkey (Türkiye)
Research Site
Konya, , Turkey (Türkiye)
Research Site
Mersin, , Turkey (Türkiye)
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Robson M, Im SA, Senkus E, Xu B, Domchek SM, Masuda N, Delaloge S, Li W, Tung N, Armstrong A, Wu W, Goessl C, Runswick S, Conte P. Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation. N Engl J Med. 2017 Aug 10;377(6):523-533. doi: 10.1056/NEJMoa1706450. Epub 2017 Jun 4.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2013-005137-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D0819C00003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.