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.
OlympiAD
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.
2 other identifiers
interventional
302
19 countries
171
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2014
Longer than P75 for phase_3
171 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2013
CompletedFirst Posted
Study publicly available on registry
December 4, 2013
CompletedStudy Start
First participant enrolled
March 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 9, 2016
CompletedResults Posted
Study results publicly available
December 22, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 23, 2025
CompletedFebruary 13, 2026
January 1, 2026
2.7 years
November 18, 2013
November 28, 2017
January 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)
Time from randomisation to the earliest of objective radiological progression or death by any cause in the absence of objective progression. Objective radiological progression is defined using Response Evaluation Criteria In Solid Tumours (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months.
Secondary Outcomes (7)
Time to Second Progression or Death (PFS2)
Second progression status reviewed every 8 weeks following the first objective radiological progression as per investigator assessment. Assessed up to a maximum of 30 months.
Overall Survival (OS)
Survival status reviewed every 3 weeks until treatment discontinued, then every 8 weeks. Assessed up to a maximum of 30 months.
Objective Response Rate (ORR) Using Blinded Independent Central Review (BICR) Data Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)
Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months.
Adjusted Mean Change in Global Health Status/Quality of Life (QoL) Score From the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30)
EORTC QLQ-C30 assessments performed at baseline then every ~6 weeks until objective radiological disease progression. Assessed up to a maximum of 30 months.
Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) in Patients Confirmed as Myriad CDx gBRCAm
Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months.
- +2 more secondary outcomes
Other Outcomes (4)
Time to First Subsequent Cancer Therapy or Death (TFST)
Subsequent cancer therapy status reviewed every 8 weeks following study treatment discontinuation. Assessed up to a maximum of 30 months.
Time to Second Subsequent Cancer Therapy or Death (TSST)
Subsequent cancer therapy status reviewed every 8 weeks following study treatment discontinuation. Assessed up to a maximum of 30 months.
Time to First Subsequent Cancer Therapy or Death (TFST) at Extended OS
Subsequent cancer therapy status reviewed every 8 weeks following study treatment discontinuation until Sep 2017 (final OS DCO), then every 3 months. Assessed up to a maximum of 64 months.
- +1 more other outcomes
Study Arms (2)
Olaparib
EXPERIMENTALOlaparib tablet 300mg bd po
Physician's choice chemotherapy
ACTIVE COMPARATORCapecitabine 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
Interventions
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.
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
You may qualify if:
- Germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious.
- 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.
You may not qualify if:
- Prior treatment with PARP inhibitor.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Myriad Genetic Laboratories, Inc.collaborator
- Merck Sharp & Dohme LLCcollaborator
Study Sites (171)
Research Site
San Diego, California, 92123, United States
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Santa Rosa, California, 95403, United States
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Whittier, California, 90602, United States
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Denver, Colorado, 80204, United States
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New Haven, Connecticut, 06510, United States
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Washington D.C., District of Columbia, 20007, United States
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Jacksonville, Florida, 32224, United States
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Orlando, Florida, 32804, United States
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Plantation, Florida, 33324, United States
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Columbus, Georgia, 31904, United States
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Marietta, Georgia, 30060, United States
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Chicago, Illinois, 60612, United States
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Niles, Illinois, 60714, United States
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Wichita, Kansas, 67214, United States
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Lafayette, Louisiana, 70506, United States
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Boston, Massachusetts, 02114, United States
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Boston, Massachusetts, 02118, United States
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Boston, Massachusetts, 02215, United States
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Detroit, Michigan, 48201, United States
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Grand Rapids, Michigan, 49503, United States
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Rochester, Minnesota, 55905-0001, United States
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Saint Louis Park, Minnesota, 55416, United States
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Jackson, Mississippi, 39202, United States
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Columbia, Missouri, 65212, United States
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St Louis, Missouri, 63131, United States
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Lebanon, New Hampshire, 03756, United States
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Commack, New York, 11725, United States
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Harrison, New York, 10604, United States
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New York, New York, 10021, United States
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New York, New York, 10065, United States
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Rockville Centre, New York, 11570, United States
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Syracuse, New York, 13210, United States
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Cincinnati, Ohio, 45267, United States
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Cleveland, Ohio, 44106, United States
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Cleveland, Ohio, 44195, United States
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Portland, Oregon, 97213, United States
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Philadelphia, Pennsylvania, 19104, United States
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Sayre, Pennsylvania, 18840, United States
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Germantown, Tennessee, 38138, United States
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Houston, Texas, 77030, United States
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Tyler, Texas, 75701, United States
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Burlington, Vermont, 05401, United States
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Plovdiv, 4000, Bulgaria
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Plovdiv, 4004, Bulgaria
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Sofia, 1233, Bulgaria
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Sofia, 1303, Bulgaria
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Sofia, 1330, Bulgaria
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Sofia, 1504, Bulgaria
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Varna, 9010, Bulgaria
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Vratsa, 3000, Bulgaria
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Beijing, 100006, China
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Beijing, 100021, China
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Beijing, 100142, China
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Changchun, 130061, China
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Changsha, 410013, China
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Chengdu, 610041, China
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Dalian, 116011, China
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Guangzhou, 510060, China
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Hangzhou, 310022, China
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Harbin, 150081, China
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Nanjing, 210009, China
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Shanghai, 200025, China
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Shanghai, 200032, China
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Shenyang, 110016, China
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Tianjin, 300060, China
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Brno, 656 53, Czechia
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Olomouc, 775 20, Czechia
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Prague, 128 08, Czechia
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Caen, 14076, France
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Montpellier, 34298, France
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Rouen, 76038, France
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Strasbourg, 67065, France
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Villejuif, 94800, France
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Budapest, 1032, Hungary
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Budapest, 1083, Hungary
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Budapest, 1115, Hungary
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Budapest, 1122, Hungary
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Budapest, 1145, Hungary
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Nyíregyháza, 4400, Hungary
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Veszprém, 8200, Hungary
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Bologna, 40138, Italy
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Naples, 80131, Italy
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Padua, 35128, Italy
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Roma, 00144, Italy
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Roma, 00168, Italy
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Rozzano, 20089, Italy
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Chūōku, 104-0045, Japan
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Chūōku, 104-8560, Japan
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Fukuoka, 811-1395, Japan
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Kagoshima, 892-0833, Japan
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Nagoya, 464-8681, Japan
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Osaka, 540-0006, Japan
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Sapporo, 003-0804, Japan
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Shinagawa-ku, 142-8666, Japan
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Suita, 565-0871, Japan
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Estado de México, 50080, Mexico
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Mérida, 97000, Mexico
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Mérida, 97070, Mexico
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Mérida, 97133, Mexico
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México, 6760, Mexico
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San Juan del Río, 76800, Mexico
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Cusco, CUSCO 01, Peru
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Lima, LIMA 01, Peru
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Lima, Lima 18, Peru
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Lima, LIMA 27, Peru
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Lima, LIMA 34, Peru
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Lima, LIMA 41, Peru
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San Borja, LIMA 41, Peru
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Elblag, 82-300, Poland
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Gdansk, 80-952, Poland
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Grzepnica, 72-003, Poland
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Lodz, 93-513, Poland
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Tarnobrzeg, 39-400, Poland
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Warsaw, 01-748, Poland
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Warsaw, 03-291, Poland
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Bucharest, 011171, Romania
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Bucharest, 013811, Romania
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Bucharest, 030171, Romania
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Cluj-Napoca, 400015, Romania
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Arkhangelsk, 163045, Russia
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Ivanovo, 153040, Russia
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Moscow, 115478, Russia
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Omsk, 644013, Russia
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Saint Petersburg, 191014, Russia
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Saint Petersburg, 195257, Russia
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Saint Petersburg, 195271, Russia
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Saint Petersburg, 197022, Russia
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Saint Petersburg, 197758, Russia
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Saransk, 430005, Russia
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Yaroslavl, 150054, Russia
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Cheongju-si, 28644, South Korea
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Daegu, 41404, South Korea
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Incheon, 21565, South Korea
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Seongnam-si, 13620, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 158-710, South Korea
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Seoul, 6351, South Korea
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Barcelona, 08003, Spain
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Córdoba, 14004, Spain
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Granada, 18014, Spain
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Madrid, 28034, Spain
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Majadahonda, 28222, Spain
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Oviedo, 33011, Spain
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Seville, 41013, Spain
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Valencia, 46026, Spain
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Zaragoza, 50009, Spain
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Bern, CH-3010, Switzerland
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Lausanne, CH-1011, Switzerland
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Zurich, 8063, Switzerland
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Kaohsiung City, 80756, Taiwan
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Taichung, 407, Taiwan
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Taipei, 10048, Taiwan
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Taipei, 10449, Taiwan
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Taipei, 11217, Taiwan
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Taoyuan District, 333, Taiwan
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Adana, 1260, Turkey (Türkiye)
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Ankara, 06230, Turkey (Türkiye)
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Edirne, 22030, Turkey (Türkiye)
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Gaziantep, 27310, Turkey (Türkiye)
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Istanbul, 34390, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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Kayseri, 38039, Turkey (Türkiye)
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Konya, 42080, Turkey (Türkiye)
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Mersin, 33110, Turkey (Türkiye)
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Aberdeen, AB25 2ZN, United Kingdom
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Colchester, CO4 5JL, United Kingdom
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Coventry, CV2 2DX, United Kingdom
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London, W6 8RF, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Plymouth, PL6 8DH., United Kingdom
Related Publications (1)
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.
PMID: 28578601DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Science Director
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Robson, MD
Memorial Sloan-Kettering Cancer Center, New York
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2013
First Posted
December 4, 2013
Study Start
March 27, 2014
Primary Completion
December 9, 2016
Study Completion
December 23, 2025
Last Updated
February 13, 2026
Results First Posted
December 22, 2017
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure