Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02032823




Registration number
NCT02032823
Ethics application status
Date submitted
3/01/2014
Date registered
10/01/2014
Date last updated
23/08/2024

Titles & IDs
Public title
Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer
Scientific 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
Secondary ID [1] 0 0
NSABP B-55
Secondary ID [2] 0 0
D081CC00006
Universal Trial Number (UTN)
Trial acronym
OlympiA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Olaparib
Treatment: Drugs - Placebo

Experimental: Olaparib - Olaparib tablets 300mg b.i.d. p.o.

Placebo comparator: Placebo - Placebo tablets b.i.d. p.o.


Treatment: Drugs: 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.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Invasive Disease Free Survival (IDFS)
Timepoint [1] 0 0
From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months)
Secondary outcome [1] 0 0
Distant Disease Free Survival (DDFS)
Timepoint [1] 0 0
From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months)
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
From date of randomisation to data cut off: 12 July 2021 (approximately 7 years 3 months)
Secondary outcome [3] 0 0
Number of Participants With Contralateral Invasive and Non-invasive Breast Cancer, New Primary Ovarian Cancer, New Primary Fallopian Tube Cancer and New Primary Peritoneal Cancer
Timepoint [3] 0 0
From date of randomisation to data cut off: 12 July 2021 (approximately 7 years 3 months)
Secondary outcome [4] 0 0
Change From Baseline for FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) Score for Participants Who Completed Neoadjuvant Chemotherapy
Timepoint [4] 0 0
6, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021)
Secondary outcome [5] 0 0
Change From Baseline for FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) Score for Participants Who Completed Adjuvant Chemotherapy
Timepoint [5] 0 0
6, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021)
Secondary outcome [6] 0 0
Change From Baseline for EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core Questions 30) Scores for Participants Who Completed Neoadjuvant Chemotherapy
Timepoint [6] 0 0
6, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021)
Secondary outcome [7] 0 0
Change From Baseline for EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core Questions 30) Scores for Participants Who Completed Adjuvant Chemotherapy
Timepoint [7] 0 0
6, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021)

Eligibility
Key inclusion criteria
* Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast that is one of the following phenotypes:

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.
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Any previous treatment with a PARP inhibitor, including olaparib and/or known hypersensitivity to any of the excipients of study treatment.
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/04/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/05/2029
Actual
Sample size
Target
Accrual to date
Final
1837
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Adelaide
Recruitment hospital [2] 0 0
Research Site - Auchenflower
Recruitment hospital [3] 0 0
Research Site - Concord
Recruitment hospital [4] 0 0
Research Site - Douglas
Recruitment hospital [5] 0 0
Research Site - Gosford
Recruitment hospital [6] 0 0
Research Site - Hobart
Recruitment hospital [7] 0 0
Research Site - Malvern
Recruitment hospital [8] 0 0
Research Site - Melbourne
Recruitment hospital [9] 0 0
Research Site - Nedlands
Recruitment hospital [10] 0 0
Research Site - Randwick
Recruitment hospital [11] 0 0
Research Site - South Brisbane
Recruitment hospital [12] 0 0
Research Site - Tamworth
Recruitment hospital [13] 0 0
Research Site - Tweed Heads
Recruitment hospital [14] 0 0
Research Site - Waratah
Recruitment hospital [15] 0 0
Research Site - Wendouree
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
2139 - Concord
Recruitment postcode(s) [4] 0 0
4814 - Douglas
Recruitment postcode(s) [5] 0 0
2250 - Gosford
Recruitment postcode(s) [6] 0 0
7000 - Hobart
Recruitment postcode(s) [7] 0 0
3144 - Malvern
Recruitment postcode(s) [8] 0 0
3000 - Melbourne
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
Recruitment postcode(s) [10] 0 0
2031 - Randwick
Recruitment postcode(s) [11] 0 0
4101 - South Brisbane
Recruitment postcode(s) [12] 0 0
2340 - Tamworth
Recruitment postcode(s) [13] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [14] 0 0
2298 - Waratah
Recruitment postcode(s) [15] 0 0
3355 - Wendouree
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
Arizona
Country [4] 0 0
United States of America
State/province [4] 0 0
Arkansas
Country [5] 0 0
United States of America
State/province [5] 0 0
California
Country [6] 0 0
United States of America
State/province [6] 0 0
Colorado
Country [7] 0 0
United States of America
State/province [7] 0 0
Connecticut
Country [8] 0 0
United States of America
State/province [8] 0 0
Delaware
Country [9] 0 0
United States of America
State/province [9] 0 0
District of Columbia
Country [10] 0 0
United States of America
State/province [10] 0 0
Florida
Country [11] 0 0
United States of America
State/province [11] 0 0
Georgia
Country [12] 0 0
United States of America
State/province [12] 0 0
Hawaii
Country [13] 0 0
United States of America
State/province [13] 0 0
Idaho
Country [14] 0 0
United States of America
State/province [14] 0 0
Illinois
Country [15] 0 0
United States of America
State/province [15] 0 0
Indiana
Country [16] 0 0
United States of America
State/province [16] 0 0
Iowa
Country [17] 0 0
United States of America
State/province [17] 0 0
Kansas
Country [18] 0 0
United States of America
State/province [18] 0 0
Kentucky
Country [19] 0 0
United States of America
State/province [19] 0 0
Louisiana
Country [20] 0 0
United States of America
State/province [20] 0 0
Maine
Country [21] 0 0
United States of America
State/province [21] 0 0
Maryland
Country [22] 0 0
United States of America
State/province [22] 0 0
Massachusetts
Country [23] 0 0
United States of America
State/province [23] 0 0
Michigan
Country [24] 0 0
United States of America
State/province [24] 0 0
Minnesota
Country [25] 0 0
United States of America
State/province [25] 0 0
Mississippi
Country [26] 0 0
United States of America
State/province [26] 0 0
Missouri
Country [27] 0 0
United States of America
State/province [27] 0 0
Montana
Country [28] 0 0
United States of America
State/province [28] 0 0
Nebraska
Country [29] 0 0
United States of America
State/province [29] 0 0
New Hampshire
Country [30] 0 0
United States of America
State/province [30] 0 0
New Jersey
Country [31] 0 0
United States of America
State/province [31] 0 0
New Mexico
Country [32] 0 0
United States of America
State/province [32] 0 0
New York
Country [33] 0 0
United States of America
State/province [33] 0 0
North Carolina
Country [34] 0 0
United States of America
State/province [34] 0 0
North Dakota
Country [35] 0 0
United States of America
State/province [35] 0 0
Ohio
Country [36] 0 0
United States of America
State/province [36] 0 0
Oklahoma
Country [37] 0 0
United States of America
State/province [37] 0 0
Oregon
Country [38] 0 0
United States of America
State/province [38] 0 0
Pennsylvania
Country [39] 0 0
United States of America
State/province [39] 0 0
South Carolina
Country [40] 0 0
United States of America
State/province [40] 0 0
South Dakota
Country [41] 0 0
United States of America
State/province [41] 0 0
Texas
Country [42] 0 0
United States of America
State/province [42] 0 0
Utah
Country [43] 0 0
United States of America
State/province [43] 0 0
Vermont
Country [44] 0 0
United States of America
State/province [44] 0 0
Virginia
Country [45] 0 0
United States of America
State/province [45] 0 0
Washington
Country [46] 0 0
United States of America
State/province [46] 0 0
West Virginia
Country [47] 0 0
United States of America
State/province [47] 0 0
Wisconsin
Country [48] 0 0
Argentina
State/province [48] 0 0
Berazategui
Country [49] 0 0
Argentina
State/province [49] 0 0
Buenos Aires
Country [50] 0 0
Argentina
State/province [50] 0 0
Caba
Country [51] 0 0
Argentina
State/province [51] 0 0
Cordoba
Country [52] 0 0
Argentina
State/province [52] 0 0
La Rioja
Country [53] 0 0
Argentina
State/province [53] 0 0
Mendoza
Country [54] 0 0
Argentina
State/province [54] 0 0
Rosario
Country [55] 0 0
Argentina
State/province [55] 0 0
San Miguel de Tucuman
Country [56] 0 0
Argentina
State/province [56] 0 0
Santa Fe
Country [57] 0 0
Austria
State/province [57] 0 0
Graz
Country [58] 0 0
Austria
State/province [58] 0 0
Innsbruck
Country [59] 0 0
Austria
State/province [59] 0 0
Leoben
Country [60] 0 0
Austria
State/province [60] 0 0
Linz
Country [61] 0 0
Austria
State/province [61] 0 0
Rankweil
Country [62] 0 0
Austria
State/province [62] 0 0
Ried
Country [63] 0 0
Austria
State/province [63] 0 0
Salzburg
Country [64] 0 0
Austria
State/province [64] 0 0
St. Veit an der Glan
Country [65] 0 0
Austria
State/province [65] 0 0
Vienna
Country [66] 0 0
Austria
State/province [66] 0 0
Villach
Country [67] 0 0
Austria
State/province [67] 0 0
Voecklabruck
Country [68] 0 0
Austria
State/province [68] 0 0
Weiz
Country [69] 0 0
Austria
State/province [69] 0 0
Wels
Country [70] 0 0
Austria
State/province [70] 0 0
Wien
Country [71] 0 0
Belgium
State/province [71] 0 0
Anderlecht
Country [72] 0 0
Belgium
State/province [72] 0 0
Brussels
Country [73] 0 0
Belgium
State/province [73] 0 0
Bruxelles
Country [74] 0 0
Belgium
State/province [74] 0 0
Charleroi
Country [75] 0 0
Belgium
State/province [75] 0 0
Edegem
Country [76] 0 0
Belgium
State/province [76] 0 0
Kortrijk
Country [77] 0 0
Belgium
State/province [77] 0 0
Leuven
Country [78] 0 0
Belgium
State/province [78] 0 0
Liege
Country [79] 0 0
Belgium
State/province [79] 0 0
Namur
Country [80] 0 0
Belgium
State/province [80] 0 0
Oostende
Country [81] 0 0
Canada
State/province [81] 0 0
Alberta
Country [82] 0 0
Canada
State/province [82] 0 0
British Columbia
Country [83] 0 0
Canada
State/province [83] 0 0
Manitoba
Country [84] 0 0
Canada
State/province [84] 0 0
Ontario
Country [85] 0 0
Canada
State/province [85] 0 0
Quebec
Country [86] 0 0
Canada
State/province [86] 0 0
Saskatchewan
Country [87] 0 0
China
State/province [87] 0 0
Beijing
Country [88] 0 0
China
State/province [88] 0 0
Changchun
Country [89] 0 0
China
State/province [89] 0 0
Chengdu
Country [90] 0 0
China
State/province [90] 0 0
Fuzhou
Country [91] 0 0
China
State/province [91] 0 0
Guangzhou
Country [92] 0 0
China
State/province [92] 0 0
Hangzhou
Country [93] 0 0
China
State/province [93] 0 0
Harbin
Country [94] 0 0
China
State/province [94] 0 0
Jinan
Country [95] 0 0
China
State/province [95] 0 0
Nanjing
Country [96] 0 0
China
State/province [96] 0 0
Shanghai
Country [97] 0 0
China
State/province [97] 0 0
Shijiazhuang
Country [98] 0 0
China
State/province [98] 0 0
Tianjin
Country [99] 0 0
France
State/province [99] 0 0
Avignon
Country [100] 0 0
France
State/province [100] 0 0
Besancon
Country [101] 0 0
France
State/province [101] 0 0
Bordeaux Cedex
Country [102] 0 0
France
State/province [102] 0 0
Brest Cedex
Country [103] 0 0
France
State/province [103] 0 0
Caen Cedex 05
Country [104] 0 0
France
State/province [104] 0 0
Clermont Ferrand cedex 01
Country [105] 0 0
France
State/province [105] 0 0
Dechy
Country [106] 0 0
France
State/province [106] 0 0
La Roche sur Yon
Country [107] 0 0
France
State/province [107] 0 0
Lille Cedex
Country [108] 0 0
France
State/province [108] 0 0
Limoges Cedex
Country [109] 0 0
France
State/province [109] 0 0
Lyon Cedex 08
Country [110] 0 0
France
State/province [110] 0 0
Marseille cedex 09
Country [111] 0 0
France
State/province [111] 0 0
Marseille
Country [112] 0 0
France
State/province [112] 0 0
Montpellier
Country [113] 0 0
France
State/province [113] 0 0
Nantes
Country [114] 0 0
France
State/province [114] 0 0
Nice
Country [115] 0 0
France
State/province [115] 0 0
Paris Cedex 10
Country [116] 0 0
France
State/province [116] 0 0
Plerin SUR MER
Country [117] 0 0
France
State/province [117] 0 0
Rennes
Country [118] 0 0
France
State/province [118] 0 0
Rouen
Country [119] 0 0
France
State/province [119] 0 0
Saint Cloud
Country [120] 0 0
France
State/province [120] 0 0
STRASBOURG Cedex
Country [121] 0 0
France
State/province [121] 0 0
Toulouse Cedex 3
Country [122] 0 0
France
State/province [122] 0 0
Villejuif Cedex
Country [123] 0 0
Germany
State/province [123] 0 0
Aachen
Country [124] 0 0
Germany
State/province [124] 0 0
Augsburg
Country [125] 0 0
Germany
State/province [125] 0 0
Baden-Baden
Country [126] 0 0
Germany
State/province [126] 0 0
Berlin
Country [127] 0 0
Germany
State/province [127] 0 0
Bonn
Country [128] 0 0
Germany
State/province [128] 0 0
Bottrop
Country [129] 0 0
Germany
State/province [129] 0 0
Brandenburg
Country [130] 0 0
Germany
State/province [130] 0 0
Bremen
Country [131] 0 0
Germany
State/province [131] 0 0
Chemnitz
Country [132] 0 0
Germany
State/province [132] 0 0
Deggendorf
Country [133] 0 0
Germany
State/province [133] 0 0
Dresden
Country [134] 0 0
Germany
State/province [134] 0 0
Düsseldorf
Country [135] 0 0
Germany
State/province [135] 0 0
Ebersberg
Country [136] 0 0
Germany
State/province [136] 0 0
Eggenfelden
Country [137] 0 0
Germany
State/province [137] 0 0
Erfurt
Country [138] 0 0
Germany
State/province [138] 0 0
Erlangen
Country [139] 0 0
Germany
State/province [139] 0 0
Essen
Country [140] 0 0
Germany
State/province [140] 0 0
Esslingen am Neckar
Country [141] 0 0
Germany
State/province [141] 0 0
Frankfurt am Main
Country [142] 0 0
Germany
State/province [142] 0 0
Freiburg im Breisgau
Country [143] 0 0
Germany
State/province [143] 0 0
Fulda
Country [144] 0 0
Germany
State/province [144] 0 0
Fürth
Country [145] 0 0
Germany
State/province [145] 0 0
Gera
Country [146] 0 0
Germany
State/province [146] 0 0
Gifhorn
Country [147] 0 0
Germany
State/province [147] 0 0
Halle
Country [148] 0 0
Germany
State/province [148] 0 0
Hamburg
Country [149] 0 0
Germany
State/province [149] 0 0
Hameln
Country [150] 0 0
Germany
State/province [150] 0 0
Hannover
Country [151] 0 0
Germany
State/province [151] 0 0
Hildesheim
Country [152] 0 0
Germany
State/province [152] 0 0
Karlsruhe
Country [153] 0 0
Germany
State/province [153] 0 0
Kassel
Country [154] 0 0
Germany
State/province [154] 0 0
Koblenz Am Rhein
Country [155] 0 0
Germany
State/province [155] 0 0
Köln
Country [156] 0 0
Germany
State/province [156] 0 0
Leipzig
Country [157] 0 0
Germany
State/province [157] 0 0
Mainz Am Rhein
Country [158] 0 0
Germany
State/province [158] 0 0
Mannheim
Country [159] 0 0
Germany
State/province [159] 0 0
Memmingen
Country [160] 0 0
Germany
State/province [160] 0 0
Mühlhausen
Country [161] 0 0
Germany
State/province [161] 0 0
Mühlheim An Der Ruhr
Country [162] 0 0
Germany
State/province [162] 0 0
München
Country [163] 0 0
Germany
State/province [163] 0 0
Münster
Country [164] 0 0
Germany
State/province [164] 0 0
Nordhausen
Country [165] 0 0
Germany
State/province [165] 0 0
Offenbach am Main
Country [166] 0 0
Germany
State/province [166] 0 0
Onkologisch Hämatologische Sch
Country [167] 0 0
Germany
State/province [167] 0 0
Paderborn
Country [168] 0 0
Germany
State/province [168] 0 0
Ravensburg
Country [169] 0 0
Germany
State/province [169] 0 0
Recklinghausen
Country [170] 0 0
Germany
State/province [170] 0 0
Rostock
Country [171] 0 0
Germany
State/province [171] 0 0
Rotenburg
Country [172] 0 0
Germany
State/province [172] 0 0
Saarbrücken
Country [173] 0 0
Germany
State/province [173] 0 0
Schweinfurt
Country [174] 0 0
Germany
State/province [174] 0 0
Stendal
Country [175] 0 0
Germany
State/province [175] 0 0
Tübingen
Country [176] 0 0
Germany
State/province [176] 0 0
Ulm
Country [177] 0 0
Germany
State/province [177] 0 0
Witten
Country [178] 0 0
Hungary
State/province [178] 0 0
Budapest
Country [179] 0 0
Iceland
State/province [179] 0 0
Reykjavík
Country [180] 0 0
Israel
State/province [180] 0 0
Jerusalem
Country [181] 0 0
Israel
State/province [181] 0 0
Petah Tikva
Country [182] 0 0
Israel
State/province [182] 0 0
Ramat Gan
Country [183] 0 0
Israel
State/province [183] 0 0
Tel-Aviv
Country [184] 0 0
Italy
State/province [184] 0 0
Bergamo
Country [185] 0 0
Italy
State/province [185] 0 0
Bologna
Country [186] 0 0
Italy
State/province [186] 0 0
Bolzano
Country [187] 0 0
Italy
State/province [187] 0 0
Castellanza Varese
Country [188] 0 0
Italy
State/province [188] 0 0
Lecce
Country [189] 0 0
Italy
State/province [189] 0 0
Legnago
Country [190] 0 0
Italy
State/province [190] 0 0
Milano
Country [191] 0 0
Italy
State/province [191] 0 0
Modena
Country [192] 0 0
Italy
State/province [192] 0 0
Napoli
Country [193] 0 0
Italy
State/province [193] 0 0
Nehrar
Country [194] 0 0
Italy
State/province [194] 0 0
Padova
Country [195] 0 0
Italy
State/province [195] 0 0
Palermo
Country [196] 0 0
Italy
State/province [196] 0 0
Pavia
Country [197] 0 0
Italy
State/province [197] 0 0
Perugia
Country [198] 0 0
Italy
State/province [198] 0 0
Prato
Country [199] 0 0
Italy
State/province [199] 0 0
Rimini
Country [200] 0 0
Italy
State/province [200] 0 0
Saronno
Country [201] 0 0
Italy
State/province [201] 0 0
Varese
Country [202] 0 0
Italy
State/province [202] 0 0
Viterbo
Country [203] 0 0
Japan
State/province [203] 0 0
Chiba-shi
Country [204] 0 0
Japan
State/province [204] 0 0
Chuo-ku
Country [205] 0 0
Japan
State/province [205] 0 0
Fukuoka-shi
Country [206] 0 0
Japan
State/province [206] 0 0
Hidaka-shi
Country [207] 0 0
Japan
State/province [207] 0 0
Hiroshima-shi
Country [208] 0 0
Japan
State/province [208] 0 0
Isehara-shi
Country [209] 0 0
Japan
State/province [209] 0 0
Kagoshima-shi
Country [210] 0 0
Japan
State/province [210] 0 0
Kashiwa
Country [211] 0 0
Japan
State/province [211] 0 0
Kawasaki-shi
Country [212] 0 0
Japan
State/province [212] 0 0
Koto-ku
Country [213] 0 0
Japan
State/province [213] 0 0
Kyoto-shi
Country [214] 0 0
Japan
State/province [214] 0 0
Matsuyama-shi
Country [215] 0 0
Japan
State/province [215] 0 0
Morioka-shi
Country [216] 0 0
Japan
State/province [216] 0 0
Nagoya-shi
Country [217] 0 0
Japan
State/province [217] 0 0
Nankoku-shi
Country [218] 0 0
Japan
State/province [218] 0 0
Niigata-shi
Country [219] 0 0
Japan
State/province [219] 0 0
Osaka-city
Country [220] 0 0
Japan
State/province [220] 0 0
Osaka-shi
Country [221] 0 0
Japan
State/province [221] 0 0
Ota-shi
Country [222] 0 0
Japan
State/province [222] 0 0
Sapporo-shi
Country [223] 0 0
Japan
State/province [223] 0 0
Shinagawa-ku
Country [224] 0 0
Japan
State/province [224] 0 0
Shizuoka
Country [225] 0 0
Japan
State/province [225] 0 0
Suita-city
Country [226] 0 0
Korea, Republic of
State/province [226] 0 0
Daegu
Country [227] 0 0
Korea, Republic of
State/province [227] 0 0
Goyang-si
Country [228] 0 0
Korea, Republic of
State/province [228] 0 0
Incheon
Country [229] 0 0
Korea, Republic of
State/province [229] 0 0
Seongnam-si
Country [230] 0 0
Korea, Republic of
State/province [230] 0 0
Seoul
Country [231] 0 0
Netherlands
State/province [231] 0 0
Amsterdam
Country [232] 0 0
Netherlands
State/province [232] 0 0
Breda
Country [233] 0 0
Netherlands
State/province [233] 0 0
Geleen
Country [234] 0 0
Netherlands
State/province [234] 0 0
Leiden
Country [235] 0 0
Netherlands
State/province [235] 0 0
Maastricht
Country [236] 0 0
Netherlands
State/province [236] 0 0
Rotterdam
Country [237] 0 0
Netherlands
State/province [237] 0 0
Zaandam
Country [238] 0 0
Poland
State/province [238] 0 0
Gdansk
Country [239] 0 0
Poland
State/province [239] 0 0
Grzepnica
Country [240] 0 0
Poland
State/province [240] 0 0
Olsztyn
Country [241] 0 0
Poland
State/province [241] 0 0
Poznan
Country [242] 0 0
Poland
State/province [242] 0 0
Warszawa
Country [243] 0 0
Poland
State/province [243] 0 0
Lódz
Country [244] 0 0
Portugal
State/province [244] 0 0
Lisboa
Country [245] 0 0
Portugal
State/province [245] 0 0
Loures
Country [246] 0 0
Portugal
State/province [246] 0 0
Porto
Country [247] 0 0
Puerto Rico
State/province [247] 0 0
San Juan
Country [248] 0 0
Spain
State/province [248] 0 0
A Coruña
Country [249] 0 0
Spain
State/province [249] 0 0
Avila
Country [250] 0 0
Spain
State/province [250] 0 0
Badajoz
Country [251] 0 0
Spain
State/province [251] 0 0
Badalona
Country [252] 0 0
Spain
State/province [252] 0 0
Barcelona
Country [253] 0 0
Spain
State/province [253] 0 0
Castelló de la Plana
Country [254] 0 0
Spain
State/province [254] 0 0
Cáceres
Country [255] 0 0
Spain
State/province [255] 0 0
Córdoba
Country [256] 0 0
Spain
State/province [256] 0 0
Elche(Alicante)
Country [257] 0 0
Spain
State/province [257] 0 0
Girona
Country [258] 0 0
Spain
State/province [258] 0 0
Hosp de Llobregat(Barcelona)
Country [259] 0 0
Spain
State/province [259] 0 0
Jaén
Country [260] 0 0
Spain
State/province [260] 0 0
La Laguna (Tenerife)
Country [261] 0 0
Spain
State/province [261] 0 0
Lugo
Country [262] 0 0
Spain
State/province [262] 0 0
Lérida
Country [263] 0 0
Spain
State/province [263] 0 0
Madrid
Country [264] 0 0
Spain
State/province [264] 0 0
Malaga
Country [265] 0 0
Spain
State/province [265] 0 0
Palma de Mallorca
Country [266] 0 0
Spain
State/province [266] 0 0
Pamplona
Country [267] 0 0
Spain
State/province [267] 0 0
Pozuelo de Alarcon
Country [268] 0 0
Spain
State/province [268] 0 0
Reus,Tarragona
Country [269] 0 0
Spain
State/province [269] 0 0
Sabadell(Barcelona)
Country [270] 0 0
Spain
State/province [270] 0 0
Salamanca
Country [271] 0 0
Spain
State/province [271] 0 0
San Sebastián
Country [272] 0 0
Spain
State/province [272] 0 0
Santiago de Compostela
Country [273] 0 0
Spain
State/province [273] 0 0
Sevilla
Country [274] 0 0
Spain
State/province [274] 0 0
Terrassa(Barcelona)
Country [275] 0 0
Spain
State/province [275] 0 0
Toledo
Country [276] 0 0
Spain
State/province [276] 0 0
Valencia
Country [277] 0 0
Spain
State/province [277] 0 0
Zaragoza
Country [278] 0 0
Sweden
State/province [278] 0 0
Göteborg
Country [279] 0 0
Sweden
State/province [279] 0 0
Linköping
Country [280] 0 0
Sweden
State/province [280] 0 0
Lund
Country [281] 0 0
Sweden
State/province [281] 0 0
Solna
Country [282] 0 0
Sweden
State/province [282] 0 0
Stockholm
Country [283] 0 0
Sweden
State/province [283] 0 0
Umeå
Country [284] 0 0
Switzerland
State/province [284] 0 0
Bern
Country [285] 0 0
Switzerland
State/province [285] 0 0
Lausanne
Country [286] 0 0
Switzerland
State/province [286] 0 0
Zürich
Country [287] 0 0
Taiwan
State/province [287] 0 0
Changhua
Country [288] 0 0
Taiwan
State/province [288] 0 0
Kaohsiung
Country [289] 0 0
Taiwan
State/province [289] 0 0
Taichung
Country [290] 0 0
Taiwan
State/province [290] 0 0
Tainan City
Country [291] 0 0
Taiwan
State/province [291] 0 0
Taipei
Country [292] 0 0
Taiwan
State/province [292] 0 0
Taoyuan
Country [293] 0 0
United Kingdom
State/province [293] 0 0
Belfast
Country [294] 0 0
United Kingdom
State/province [294] 0 0
Birmingham
Country [295] 0 0
United Kingdom
State/province [295] 0 0
Bournemouth
Country [296] 0 0
United Kingdom
State/province [296] 0 0
Bristol
Country [297] 0 0
United Kingdom
State/province [297] 0 0
Cambridge
Country [298] 0 0
United Kingdom
State/province [298] 0 0
Cardiff.
Country [299] 0 0
United Kingdom
State/province [299] 0 0
Dudley
Country [300] 0 0
United Kingdom
State/province [300] 0 0
Edinburgh
Country [301] 0 0
United Kingdom
State/province [301] 0 0
Glasgow
Country [302] 0 0
United Kingdom
State/province [302] 0 0
Leeds
Country [303] 0 0
United Kingdom
State/province [303] 0 0
London
Country [304] 0 0
United Kingdom
State/province [304] 0 0
Manchester
Country [305] 0 0
United Kingdom
State/province [305] 0 0
Nottingham
Country [306] 0 0
United Kingdom
State/province [306] 0 0
Oxford
Country [307] 0 0
United Kingdom
State/province [307] 0 0
Sheffield
Country [308] 0 0
United Kingdom
State/province [308] 0 0
Southampton
Country [309] 0 0
United Kingdom
State/province [309] 0 0
Stoke-on-Trent
Country [310] 0 0
United Kingdom
State/province [310] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Breast International Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Frontier Science & Technology Research Foundation, Inc.
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
NRG Oncology
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Commercial sector/industry
Name [4] 0 0
Myriad Genetic Laboratories, Inc.
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Br.E.A.S.T. -Data Center & Operational Office Institut Jules Bordet
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Commercial sector/industry
Name [6] 0 0
Merck Sharp & Dohme LLC
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

Summary
Brief 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
Trial website
https://clinicaltrials.gov/study/NCT02032823
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Tutt, Doctor of Medicine
Address 0 0
Integrated Cancer Centre Guy's Hospital, King's College, London School of Medicine, London, UK
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02032823