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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

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
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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
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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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02032823