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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02032823
Ethics application status
Date submitted
3/01/2014
Date registered
10/01/2014
Date last updated
5/05/2020

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) - Time from randomisation to date of first treatment failure that is loco-regional or distant recurrence or new cancer or death from any cause
Timepoint [1] 0 0
Up to 10 years
Secondary outcome [1] 0 0
Overall survival (OS) - Efficacy by assessment of OS (time from randomisation to death by any cause).
Timepoint [1] 0 0
Until 10 years after the last patient is randomised
Secondary outcome [2] 0 0
Distant Disease Free Survival (DDFS) - Time from randomisation until documented evidence of first distant recurrence of breast cancer
Timepoint [2] 0 0
Up to 10 years
Secondary outcome [3] 0 0
Effect on the incidence of new primary contralateral breast cancers, new primary ovarian cancer, new primary fallopian tube cancer and new primary peritoneal cancer - Time from randomisation until documented incidence of new primary contralateral breast cancers, new primary ovarian cancer, new primary fallopian tube cancer and new primary peritoneal cancer
Timepoint [3] 0 0
Up to 10 years
Secondary outcome [4] 0 0
Effect in patients identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays. - Retrospective analysis of samples
Timepoint [4] 0 0
Up to LSLV & 15 years thereafter
Secondary outcome [5] 0 0
Exposure to Olaparib (in plasma) in patients receiving Olaparib as adjuvant therapy - Pharmacokinetic analysis
Timepoint [5] 0 0
Visit 4, day 29
Secondary outcome [6] 0 0
FACIT-Fatiure symptoms and EORTC QLQ-C30 Questionnaires - Assess weather olaparib arm patients may experience greater fatigue (FACIT-Fatigue), greater GI symptoms and no difference in Quality of Life (EORTC QLQ-C30)
Timepoint [6] 0 0
Up to 2 years

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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
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5000 - Adelaide
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4066 - Auchenflower
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3355 - Wendouree
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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 Corp.
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/show/NCT02032823
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

Summary results
Other publications