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

NCT02032823

Active Not RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Breast Cancer

Interventions: Olaparib, Placebo

Countries: United States, Argentina, Australia, Austria, Belgium, Canada, China, France

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

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

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

Locations (698)

Anchorage, Alabama, United States
Anchorage, Alaska, United States
Gilbert, Arizona, United States
Fort Smith, Arkansas, United States
Baldwin Park, California, United States
Berkeley, California, United States
Duarte, California, United States
Fontana, California, United States
Fresno, California, United States
Greenbrae, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Martinez, California, United States
Newport Beach, California, United States
Oakland, California, United States
Palo Alto, California, United States
Paradise, California, United States
Roseville, California, United States
Roseville, California, United States
Sacramento, California, United States
San Francisco, California, United States
San Jose, California, United States
San Leandro, California, United States
San Marcos, California, United States
Santa Cruz, California, United States
Santa Rosa, California, United States
South San Francisco, California, United States
Stockton, California, United States
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