Olaparib as adjuvant treatment in patients with germline BRCA mutated high risk HER2 negative primary breast cancer - OlympiA

Study identifier:D081CC00006

ClinicalTrials.gov identifier:NCT02032823

EudraCT identifier:2013-003839-30

CTIS identifier:N/A

Recruitment Complete

Official 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

Medical condition

Breast Cancer

Phase

Phase 3

Healthy volunteers

Study drug

Olaparib, Placebo

Sex

All

Actual Enrollment

1836

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 22 Apr 2014

Primary Completion Date: 27 Mar 2020

Estimated Study Completion Date: 28 May 2029

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2024 by AstraZeneca

Collaborators

Breast International Group, Frontier Science and Technology Research Foundation, Inc., NRG Oncology, Myriad Genetics - BRACAnalysis test for FDA Premarket Approval (PMA), Br.E.A.S.T. -Data Center & Operational Office Institut Jules Bordet, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Inclusion and exclusion criteria

Inclusion Criteria

•Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast that is one of the following phenotypes:
a)Triple negative breast cancer defined as: ER and PgR negative AND HER2 negative (not eligible for anti-HER2 therapy)
b) 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

•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:
a) 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
b) 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

No locations available

Arms	Assigned Interventions
Experimental: Olaparib Olaparib tablets 300mg b.i.d. p.o.	Drug: 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. Other Name: Lynparza
Placebo Comparator: Placebo Placebo tablets b.i.d. p.o.	Drug: 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.

Documents available

AstraZeneca Cancer Study Locator Service Phone: 877 400 4656 Email: [email protected]
Download
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D081CC00006&attachmentIdentifier=dee7be50-99d3-44f3-8f8a-ffb3ca728507&fileName=Olympia_CTT_Redacted_Protocols_and_SAP_23Sept2021_PDF_A_Redacted_final.pdf&versionIdentifier=
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Contact Backup

Reagrding US sites please contact NRG Oncology Clinical Coordinating Department

1-800-477-7227

Investigators

Principal Investigator

Andrew Tutt

Integrated Cancer Centre Guy's Hospital, King's College, London School of Medicine, London, UK