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Spots Global Cancer Trial Database for Platinum and Polyadenosine 5'Diphosphoribose Polymerisation Inhibitor for Neoadjuvant Treatment of Triple Negative Breast Cancer and/or Germline BRCA Positive Breast Cancer

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Trial Identification

Brief Title: Platinum and Polyadenosine 5'Diphosphoribose Polymerisation Inhibitor for Neoadjuvant Treatment of Triple Negative Breast Cancer and/or Germline BRCA Positive Breast Cancer

Official Title: Randomised, Phase II/III, 3 Stage Trial to Evaluate the Safety and Efficacy of the Addition of Olaparib to Platinum-based Neoadjuvant Chemotherapy in Breast Cancer Patients With TNBC and/or gBRCA.

Study ID: NCT03150576

Conditions

Breast Cancer

Study Description

Brief Summary: This neoadjuvant trial for patients with TNBC and/or gBRCA breast cancer, aims to investigate the safety and efficacy (improvement in pathological Complete Response at surgery) of concurrent platinum-based chemotherapy with olaparib an inhibitor of the PARP enzyme (PARPi).

Detailed Description: Randomised, phase II/III 3 stage trial to evaluate the safety and efficacy of the addition of olaparib to platinum-based neoadjuvant chemotherapy in breast cancer patients with TNBC and/or gBRCA. Disease under investigation: Breast Cancer Purpose of clinical trial: To establish if the addition of olaparib to neoadjuvant platinum-based chemotherapy for Triple Negative Breast Cancer (TNBC) and/or germline BRCA (gBRCA) breast cancer is safe and improves efficacy. Trial Design: Open label, randomised, 3-stage Phase II/III Sample Size: Minimum of 780 patients (including at least 220 gBRCA patients equally allocated to the control and the selected research arm). Non Investigational Medicinal Products: Prophylactic granulocyte-colony stimulating factor (G-CSF) to be given as per local practice and 3 cycles of anthracyclines as per local practice. Treatment period: A minimum of 21 weeks of chemotherapy followed by surgery. Procedures: Screening \& enrolment Eligible patients with early breast cancer will be registered and consented for screening: BRCA mutation test Tumour Infiltrating Lymphocytes(TILs) score Cytokeratin 5/6 (CK5/6), Epidermal Growth Factor Receptor (EGFR) +/-, Androgen Receptor (AR) status by Immunohistochemistry (IHC). Standard assessment prior to chemotherapy Standard staging to exclude metastatic disease. When eligibility is confirmed, patients will be randomised via a web-based central system which will allocate each patient a unique randomisation number associated with one of the treatment arms. PARTNERing Pathway - For those patients who still have residual disease after receiving neoadjuvant chemotherapy +/- olaparib there is the opportunity to be screened to a sub-study to receive a further two cycles of chemotherapy consisting of Duralumab and AZD6738. End of Trial: For patients, the end of trial is after the last follow-up visit or contact with the research team planned 10 years after surgery. Procedures for safety monitoring during trial: Pharmacovigilance will be performed by the PARTNER Trial Office. Also, the Trial Management Group and the Independent Data and Safety Monitoring Committee will regularly review the patient safety data. Criteria for discontinuation of trial treatment on safety grounds: Severe toxicity or inter-current illness, requiring cessation in the judgement of patient's clinician. Patient within 4 weeks has not recovered from toxicity to an extent that allows further treatment. Patient unable to comply with trial procedures. Disease progression while on trial treatment. Patient becomes pregnant.

Eligibility

Minimum Age: 16 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Cambridge University Hospitals NHS Foundation Trust & the University of Cambridge, Cambridge, Cambridgeshire, United Kingdom

Queen's Hospital, Burton Upon Trent, Derby, United Kingdom

The Christie, Manchester, Lancs, United Kingdom

Pinderfields General Hospital, Wakefield, Yorkshire, United Kingdom

University Hospital Ayr, Ayr, , United Kingdom

Basingstoke and North Hampshire Hospital, Basingstoke, , United Kingdom

Bedford General Hospital, Bedford, , United Kingdom

Royal Bournemouth Hospital, Bournemouth, , United Kingdom

Bristol Haematology & Cancer Centre, Bristol, , United Kingdom

West Suffolk Hospital, Bury Saint Edmunds, , United Kingdom

Velindre Cancer Centre, Cardiff, , United Kingdom

Colchester General Hospital, Colchester, , United Kingdom

Russells Hall Hospital, Dudley, , United Kingdom

Hinchingbrooke Hospital, Huntingdon, , United Kingdom

Ipswich Hospital, Ipswich, , United Kingdom

Kidderminster General Hospital, Kidderminster, , United Kingdom

University Hospital Crosshouse, Kilmarnock, , United Kingdom

University College London Hospital, London, , United Kingdom

Royal Free Hospital, London, , United Kingdom

Mount Vernon Cancer Centre, Northwood, , United Kingdom

Nottingham City Hospital, Nottingham, , United Kingdom

Churchill Hospital, Oxford, , United Kingdom

Peterborough City Hospital, Peterborough, , United Kingdom

Poole Hospital, Poole, , United Kingdom

The Alexandra Hopsital, Redditch, , United Kingdom

Queen's Hospital, Romford, , United Kingdom

Southampton General Hospital, Southampton, , United Kingdom

Singleton Hospital, Swansea, , United Kingdom

Royal Hampshire County Hospital, Winchester, , United Kingdom

Worcestershire Royal Hospital, Worcester, , United Kingdom

Contact Details

Name: Jean Abraham

Affiliation: The University of Cambridge, Department of Oncology

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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