Olaparib for Breast cancer

Inclusion criteria

• {"criterion_text":"- 18 years old and older"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- Completed adequate breast and axilla surgery."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- ECOG 0-1.R50"}

Exclusion criteria

• {"criterion_text":"- Any previous treatment with a PARP inhibitor, including olaparib and/or known hypersensitivity to any of the excipients of study treatment."}
• {"criterion_text":"- 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 ≥ 5years prior to randomisation and treated with no evidence of disease recurrence and for whom no more than one line of chemotherapy was applied."}
• {"criterion_text":"- 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 orphenobarbital and 3 weeks for other agents."}
• {"criterion_text":"- Whole blood transfusions in the last 120 days prior to entry to the study which may interfere with gBRCA testing"}
• {"criterion_text":"- Evidence of metastatic breast cancer"}

Primary endpoints

• {"endpoint_text":"- Invasive Disease Free Survival (IDFS)","definition_or_measurement_approach":"Efficacy of adjuvant treatment with olaparib on Invasive Disease Free Survival (IDFS)."}

Secondary endpoints

• {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":"Overall survival (OS) measured as time from randomisation to death from any cause."}
• {"endpoint_text":"- Distant Disease Free Survival (DDFS)","definition_or_measurement_approach":"Distant Disease Free Survival (DDFS) measured as time to distant recurrence."}
• {"endpoint_text":"- Incidence of new primary contralateral invasive breast cancer, primary contralateral non-invasive breast cancer, new primary ovarian cancer, new primary fallopian tube cancer and new primary peritoneal cancer","definition_or_measurement_approach":"Incidence rates of specified new primary cancers as listed."}
• {"endpoint_text":"- Patient Reported Outcomes from FACIT Fatigue and EORTCQLQ-C30 QoL questionnaires","definition_or_measurement_approach":"Patient-reported outcomes collected using FACIT Fatigue and EORTC QLQ-C30 questionnaires."}
• {"endpoint_text":"- Determination of BRCA mutation status using current and future BRCA mutation assays (gene sequencing and large rearrangement analysis)","definition_or_measurement_approach":"BRCA mutation status determined by gene sequencing and large rearrangement analysis (current and future BRCA assays)."}
• {"endpoint_text":"- Exposure to olaparib (in plasma) in patients receiving olaparib as adjuvant therapy","definition_or_measurement_approach":"Measurement of olaparib plasma exposure (pharmacokinetic sampling)."}
• {"endpoint_text":"- Safety","definition_or_measurement_approach":"Safety assessed by adverse event reporting and clinical/laboratory assessments."}

Primary sponsor

Full Name

AstraZeneca AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden