ABCSG 45: A clinical trial that examines whether the treatment with the medication olaparib in combination with the chemotherapy carboplatin is more effective than treatment with a standard chemotherapy (anthracycline/taxane-based) against a specific type of breast cancer (triple-negative) with a biologic characteristic (homologous recombination deficiency)

INTERVENTION: Product Name: Lynparza 100 mg film‐coated tablets,Product Code: PRD6163472,Pharmaceutical Form: FILM‐COATED TABLET,Other descriptive name: ,Strength: Olaparib 100mg,Product Name: Lynparza 150 mg film‐coated tablets,Product Code: PRD6152224,Pharmaceutical Form: FILM‐COATED TABLET,Other descriptive name: ,Strength: Olaparib 150mg,Product Name: CYCLOPHOSPHAMIDE,Product Code: SUB06859MIG,Pharmaceutical Form: POWDER FOR SOLUTION FOR INJECTION,Other descriptive name: ,Strength: 200mg,Product Name: EPIRUBICIN,Product Code: SUB06571MIG,Pharmaceutical Form: CONCENTRATE FOR SOLUTION FOR INFUSION,Other descriptive name: ,Strength: 2mg,Product Name: DOCETAXEL,Product Code: SUB12492MIG,Pharmaceutical Form: CONCENTRATE FOR SOLUTION FOR INFUSION,Other descriptive name: ,Strength: 10mg,Product Name: CARBOPLATIN,Product Code: SUB06614MIG,Pharmaceutical Form: SOLUTION FOR INFUSION,Other descriptive name: ,Strength: 10mg,Product Name: DOXORUBICIN,Product Code: SUB06391MIG,Pharmaceutical Form: CONCENTRATE FOR SOLUTION FOR INFUSION,Other descriptive name: ,Strength: 2mg CONDITION: Early invasive triple negative breast cancer with positive HRD status (acc. to Myriad mychoice© test) ; MedDRA version: 20.0Level: PTClassification code: 10075566Term: Triple negative breast cancerSystem Organ Class: 100000004864 MedDRA version: 20.0Level: PTClassification code: 10075566Term: Triple negative breast cancerSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] ‐ Neoplasms [C04] PRIMARY OUTCOME: Main Objective:To compare the efficacy of 6 cycles of pre‐operative carboplatin/olaparib with 6 cycles of pre‐operative taxane/anthracycline‐based chemotherapy (TAC) in tumors exhibiting positive homologous recombination deficiency (HRD) status when measured by centrally assessed RCB at the time of surgery. Primary end point(s):Main study: Histo‐pathological response to pre‐operative carboplatin/olaparib compared with pre‐operative TAC‐based chemotherapy when measured by centrally assessed RCB (RCB‐0/I versus RCB‐II/III).,Substudy: Incidence, nature and severity of adverse events (AEs) graded according to NCI CTCAE, most current version. Secondary Objective:To compare the efficacy of 6 cycles of pre‐operative carboplatin/olaparib with 6 cycles of pre‐operative taxane/anthracycline‐based chemotherapy (TAC) in tumors exhibiting positive HRD status when measured by pCR at the time of surgery.,To compare patient‐reported quality of life (QoL) and sexual health (SH) in patients treated with pre‐operative carboplatin/olaparib vs. patients treated with pre‐operative TAC overall and by subgroups defined by menopausal status (only women) or age at randomization at multiple pre‐specified time points. SECONDARY OUTCOME: Secondary end point(s):Main study: Occurrence of pCR at the time of surgery. Secondary end point(s):Main study: Quality of Life and sexual health scores and changes from baseline as measured using EORTC QLQ‐C30, EORTC QLQ‐BR45 and EORTC SHQ‐C22. INCLUSION CRITERIA: Main study: 1. Signed informed consent prior to any study specific assessments and procedures,Main study: 7. Willingness to undergo adequate lymph node procedures (e.g., sentinel/ axillary lymph node dissection) acc. to institutional standards,Main study: 8. Patients must have normal organ and bone marrow function measured within 28 days prior to randomization as defined below: • Haemoglobin (Hb) =10.0 g/dL • Absolute neutrophil count (ANC) =1.5 X109/L • Absence of known Myelodysplastic Syndrome (MDS)/ Acute Myeloid Leukaemia (AML) and no features suggestive of MDS/ AML on *peripheral blood smear (*For patients randomized according to protocol version 2.0, peripheral blood smear only has to be performed if haematology assessment during screening shows abnormalities that require further clarification) • White blood cell (WBC) count = 3.0 X109/L • Platelet count =100 X109/L • Total bilirubin =1.5 Xinstitutional upper limit of normal (ULN) • AST (SGOT)/ ALT (SGP