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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1800

Inclusion Criteria

-18 years old and older
- Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast that is one of the following phenotypes:
a)TNBC ER and PgR negative AND HER2 negative (not eligible for anti-HER2 therapy)
b) ER and/or PgR positive, HER2 negative ER and/or PgR positive AND HER2 negative (not eligible for anti-HER2 therapy)
-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 of 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 500

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.
-Whole blood transfusions in the last 120 days prior to entry to the study which may interfere with gBRCA testing
- Evidence of metastatic breast cancer

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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