The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
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
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.
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Jean Abraham
Affiliation: The University of Cambridge, Department of Oncology
Role: PRINCIPAL_INVESTIGATOR