Who is eligible for clinical trial NCT02032823?

Participants must meet the protocol's inclusion criteria for Breast Cancer. The stated age range is 18 Years to 130 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT02032823 provide travel or cost reimbursement?

The protocol indicates compensation for participation. See the verified compensation note below. Confirm stipend details with the site coordinator.

🏛️ Verified NIH Record • Updated 2026-07-13

Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer (NCT02032823)

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

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: AstraZeneca

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (7 items).

Location: Research Site — Anchorage, Alabama

Age range: 18 Years to 130 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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:
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
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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (698 Sites)

Showing the first 25 of 698 sites.

Research Site — Anchorage, Alabama
Research Site — Anchorage, Alaska
Research Site — Gilbert, Arizona
Research Site — Fort Smith, Arkansas
Research Site — Baldwin Park, California
Research Site — Berkeley, California
Research Site — Duarte, California
Research Site — Fontana, California
Research Site — Fresno, California
Research Site — Greenbrae, California
Research Site — Los Angeles, California
Research Site — Los Angeles, California
Research Site — Los Angeles, California
Research Site — Los Angeles, California
Research Site — Martinez, California
Research Site — Newport Beach, California
Research Site — Oakland, California
Research Site — Palo Alto, California
Research Site — Paradise, California
Research Site — Roseville, California
Research Site — Roseville, California
Research Site — Sacramento, California
Research Site — San Francisco, California
Research Site — San Jose, California
Research Site — San Leandro, California

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
💵 Compensation indicated: Randomised patients will receive study treatment for up to a maximum of 12 months.

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💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗