Olaparib & Radiation Therapy for Patients Triple Negative Breast Cancer (TNBC)

Inclusion Criteria

• •1. Woman aged \>18 years.
• •2. Histologically confirmed triple negative breast cancer with loco-regional radiotherapy indication :
• •1. Non-operated with either:
• •1. Inflammatory breast cancer in progression during neoadjuvant chemotherapy or inoperable after neoadjuvant chemotherapy.
• •2. Loco-regional advanced breast cancer in progression during neoadjuvant chemotherapy or inoperable after neoadjuvant chemotherapy (T ≥ 3 and/or N ≥ 1; with evaluable disease according to RECIST 1.1 criteria).
• •3. Non operable metastatic breast cancer (all T, all N, M1; with evaluable disease according to RECIST 1.1 criteria) needing local and regional treatment in case of good metastatic control after chemotherapy.
• •2. Or patient operated after neoadjuvant treatment and surgery with residual disease (non-pCR and/or pN+ disease).
• •3. Neoadjuvant chemotherapy (containing anthracyclines or taxanes or the combination of both or containing platinum-based chemotherapy) willingness to discontinue any cytotoxic chemotherapeutic agents, immunotherapy, and targeted therapies at least two weeks prior to start of Olaparib.
• •4. ECOG performance status \< 2.
• •5. Life expectancy greater than 6 months.
• •6. Adequate hematologic, renal and hepatic function (assessed within the two weeks prior to registration and within the month prior to the commencement of protocol treatment). For patients who have stopped chemotherapy two weeks prior to protocol treatment, hematologic function must be re-assessment 1 or 2 days before the first Olaparib intake:
• •1. Haemoglobin ≥ 10.0 g/dL.
• •2. Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L.
• •3. White Blood Cells (WBC) \> 3 x 109/L.
• •4. Platelet count ≥ 100 x 109/L.
• •5. Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (except in case of Gilbert syndrome).
• •6. AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5 x ULN.
• •7. Patients must have Creatinine Clearance estimated using the Cockcroft-Gault equation of ≥ 51 mL/min
• •7. Urine or serum negative pregnancy test within two weeks prior to registration for non-postmenopausal patients. Negative pregnancy test confirmed within 1 or 2 days prior to first Olaparib intake.
• •8. For woman with child-bearing potential, an efficacious contraception following sponsor recommendations must be used during the whole treatment period and up to three months after the last Olaparib administration.
• •9. Ability to swallow and retain oral medications without gastrointestinal disorders likely to interfere with absorption of the study medication.
• •10. Affiliation to the French Social Security System.
• •11. Ability to understand and the willingness to sign a written informed consent document.