Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer
NCT ID: NCT02032823
Last Updated: 2026-01-16
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1836 participants
INTERVENTIONAL
2014-04-22
2029-05-28
Brief Summary
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Detailed Description
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Randomised patients will receive study treatment for up to a maximum of 12 months. All patients will have safety assessments every 2 weeks during the first month, every 4 weeks for the following 5 months and 3 monthly for the remaining 6 months of study treatment plus 30 days after its discontinuation. Following randomisation, all patients will be assessed regularly for signs, symptoms and evidence of disease recurrence by taking medical history, physical examination and mammogram/breast MRI. Efficacy assessments will be performed on a 3 monthly basis during the first 2 years, followed by 6 monthly assessments for years 3, 4 and 5 and annually thereafter. All patients (except those with bilateral mastectomy) will have mammogram / breast MRI annually for 10 years beginning 6 months after randomisation.
All randomised patients will have clinical assessment visits for 10 years following their randomisation into the study. Once a patient completes 10 years of clinical assessment they will enter the survival follow up phase of the trial which will continue until approximately 10 years after the last patient is randomised.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Olaparib
Olaparib tablets 300mg b.i.d. p.o.
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
Placebo tablets b.i.d. p.o.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Triple negative breast cancer defined as: ER and PgR negative AND HER2 negative (not eligible for anti-HER2 therapy)
2. ER and/or PgR positive, HER2 negative
* Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function).
* Completed adequate breast and axilla surgery.
* Completed at least 6 cycles neoadjuvant or adjuvant chemotherapy containing anthracyclines, taxanes or the combination of both. Prior platinum as potentially curative treatment for prior cancer (e.g. ovarian) or as adjuvant or neoadjuvant treatment for breast cancer is allowed.
* ECOG 0-1.
Exclusion Criteria
* Patients with second primary malignancy. EXCEPTIONS are:
1. adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, Ductal Carcinoma in situ (DCIS) of the breast, stage 1 grade 1 endometrial carcinoma
2. other solid tumours and lymphomas (without bone marrow involvement) diagnosed ≥ 5 years prior to randomisation and treated with no evidence of disease recurrence and for whom no more than one line of chemotherapy was applied.
* Concomitant use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g., ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting study treatment is 2 weeks. Concomitant use of known strong (e.g., phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g., bosentan, efavirenz, modafinil). The required washout period prior to starting study treatment is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
* Evidence of metastatic breast cancer
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Breast International Group
OTHER
Frontier Science & Technology Research Foundation, Inc.
INDUSTRY
NRG Oncology
OTHER
Myriad Genetic Laboratories, Inc.
INDUSTRY
The Breast Adjuvant Study Team
OTHER
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Andrew Tutt, Doctor of Medicine
Role: PRINCIPAL_INVESTIGATOR
Integrated Cancer Centre Guy's Hospital, King's College, London School of Medicine, London, UK
Judy Garber, Doctor of Medicine
Role: PRINCIPAL_INVESTIGATOR
Harvard Medical School, Center for Cancer Genetics and Prevention, Dana-Farber Cancer Institute, Susan F. Smither Center for Women's Cancers, 450 Brookline Avenue, Boston; MA 02215, US
Charles Geyer, Doctor of Medicine
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University Massey Cancer Center, McGlothlin Medical Education Center, Room 12-217, 1201 East Marshall St., PO Box 980070, Richmond, VA 23298-0070, USA
Locations
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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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Greenbrae, California, United States
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Martinez, California, United States
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Palo Alto, California, United States
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Santa Cruz, California, United States
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Stockton, California, United States
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Sunnyvale, California, United States
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Vacaville, California, United States
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Vallejo, California, United States
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Brooklyn, New York, United States
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Clairton, Pennsylvania, United States
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Gettysburg, Pennsylvania, United States
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Harrisburg, Pennsylvania, United States
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Hershey, 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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Charleston, South Carolina, United States
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Greenville, South Carolina, United States
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Greenwood, South Carolina, United States
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Greer, South Carolina, United States
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Seneca, South Carolina, United States
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Spartanburg, South Carolina, United States
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Sioux Falls, South Dakota, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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Round Rock, Texas, United States
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Temple, Texas, United States
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American Fork, Utah, United States
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Murray, Utah, United States
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Ogden, Utah, United States
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Provo, Utah, United States
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St. George, Utah, United States
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Berlin Corners, Vermont, United States
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Annandale, Virginia, United States
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Fredericksburg, Virginia, United States
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Lynchburg, Virginia, United States
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Poulsbo, Washington, United States
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Berazategui, , Argentina
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References
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Ganz PA, Bandos H, Spanic T, Friedman S, Muller V, Kuemmel S, Delaloge S, Brain E, Toi M, Yamauchi H, de Duenas EM, Armstrong A, Im SA, Song CG, Zheng H, Sarosiek T, Sharma P, Geng C, Fu P, Rhiem K, Frauchiger-Heuer H, Wimberger P, t'Kint de Roodenbeke D, Liao N, Goodwin A, Chakiba-Brugere C, Friedlander M, Lee KS, Giacchetti S, Takano T, Henao-Carrasco F, Virani S, Valdes-Albini F, Domchek SM, Bane C, McCarron EC, Mita M, Rossi G, Rastogi P, Fielding A, Gelber RD, Scheepers ED, Cameron D, Garber J, Geyer CE, Tutt ANJ. Patient-Reported Outcomes in OlympiA: A Phase III, Randomized, Placebo-Controlled Trial of Adjuvant Olaparib in gBRCA1/2 Mutations and High-Risk Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer. J Clin Oncol. 2024 Apr 10;42(11):1288-1300. doi: 10.1200/JCO.23.01214. Epub 2024 Feb 1.
Perachino M, Poggio F, Arecco L, Blondeaux E, Spinaci S, Marrocco C, Levaggi A, Lambertini M. Update on Pregnancy Following Breast Cancer Diagnosis and Treatment. Cancer J. 2022 May-Jun 01;28(3):176-182. doi: 10.1097/PPO.0000000000000599.
Tutt ANJ, Garber JE, Kaufman B, Viale G, Fumagalli D, Rastogi P, Gelber RD, de Azambuja E, Fielding A, Balmana J, Domchek SM, Gelmon KA, Hollingsworth SJ, Korde LA, Linderholm B, Bandos H, Senkus E, Suga JM, Shao Z, Pippas AW, Nowecki Z, Huzarski T, Ganz PA, Lucas PC, Baker N, Loibl S, McConnell R, Piccart M, Schmutzler R, Steger GG, Costantino JP, Arahmani A, Wolmark N, McFadden E, Karantza V, Lakhani SR, Yothers G, Campbell C, Geyer CE Jr; OlympiA Clinical Trial Steering Committee and Investigators. Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer. N Engl J Med. 2021 Jun 24;384(25):2394-2405. doi: 10.1056/NEJMoa2105215. Epub 2021 Jun 3.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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AstraZeneca Cancer Study Locator Service
Phone:
877 400 4656 Email: [email protected]
Other Identifiers
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NSABP B-55
Identifier Type: OTHER
Identifier Source: secondary_id
BIG 6-13
Identifier Type: OTHER
Identifier Source: secondary_id
2024-511096-15-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2013-003839-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D081CC00006
Identifier Type: -
Identifier Source: org_study_id
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