RecruitingPhase 2Phase 3NCT03150576

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

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.


Sponsor

Cambridge University Hospitals NHS Foundation Trust

Enrollment

780 participants

Start Date

May 1, 2016

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 16 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of chemotherapy drugs — carboplatin (a platinum drug) and a PARP inhibitor (a drug that blocks a DNA repair enzyme in cancer cells) — as a treatment given before surgery for triple-negative breast cancer or breast cancer in people with a BRCA gene mutation. **You may be eligible if...** - You are between 16 and 70 years old - You have been diagnosed with invasive breast cancer confirmed by biopsy - Your cancer is triple-negative (negative for estrogen receptor, HER2, and hormone receptors) - OR your cancer is HER2-negative and you carry a BRCA gene mutation - You have not yet started chemotherapy or surgery for this cancer **You may NOT be eligible if...** - Your cancer is HER2-positive - You are pregnant or breastfeeding - You have other serious medical conditions that make these drugs unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOlaparib

Patients will self-administer Olaparib by mouth. Olaparib tablets should be taken twice daily at the same time each day approximately 12 hours apart.

DRUGPaclitaxel and Carboplatin

Paclitaxel I.V. 80mg/m2 in 0.9% sodium chloride 500ml or according to local practice, will be given over 60 minutes on days 1, 8 \& 15, every 3 weeks for 4 cycles. Carboplatin I.V. AUC5 in 5% dextrose 500ml or according to local practice, over 30-60minutes on day 1 every 3 weeks for 4 cycles.


Locations(30)

Cambridge University Hospitals NHS Foundation Trust & the University of Cambridge

Cambridge, Cambridgeshire, United Kingdom

Queen's Hospital

Burton-on-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 St 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

View Full Details on ClinicalTrials.gov

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NCT03150576


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