Actively Recruiting
Platinum and Polyadenosine 5'Diphosphoribose Polymerisation Inhibitor for Neoadjuvant Treatment of Triple Negative Breast Cancer and/or Germline BRCA Positive Breast Cancer
Led by Cambridge University Hospitals NHS Foundation Trust · Updated on 2022-11-14
780
Participants Needed
30
Research Sites
943 weeks
Total Duration
On this page
Sponsors
C
Cambridge University Hospitals NHS Foundation Trust
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Platinum and Polyadenosine 5'Diphosphoribose Polymerisation Inhibitor for Neoadjuvant Treatment of Triple Negative Breast Cancer and/or Germline BRCA Positive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 16 and 70 years
- Willing and able to give written informed consent and follow the trial protocol
- Histologically confirmed invasive breast cancer
- Either ER-negative and HER2-negative breast cancer (TNBC) with any progesterone receptor status
- Or germline BRCA mutation positive, HER2-negative breast cancer of any ER/PR status
- Tumor size T1, T2, or T3
- T4 tumors extending to chest wall or skin, or inflammatory carcinoma of any size
- Locally advanced disease with involvement of large or fixed lymph nodes
- Multifocal tumor with at least one tumor larger than 10 mm
- Bilateral breast disease meeting above criteria is allowed
- Fit to receive trial chemotherapy with adequate bone marrow, liver, and kidney function
- ECOG performance status 0 or 1
- Treatment to start within 6 weeks of diagnostic biopsy (up to 9 weeks if medically acceptable)
- Availability of Tumor Infiltrating Lymphocytes score
- Availability of CK 5/6, EGFR, and androgen receptor immunohistochemistry scores
- Availability of biopsy and surgical tissue samples
- Women of child-bearing potential must have a negative pregnancy test within 14 days before randomisation
- Effective contraception required during treatment and for 6 months after last dose for all sexually active participants and partners
You will not qualify if you...
- Tumor classified as T0 without axillary lymph node larger than 10 mm
- TNBC with non-basal phenotype strongly expressing androgen receptor
- Previous or current chemotherapy or biological cancer treatment within last 5 years
- Other malignancy within last 5 years except certain treated skin, cervical, breast, endometrial cancers, or lymphomas without bone marrow involvement
- Myelodysplastic syndrome or acute myeloid leukemia
- Evidence of distant metastasis before randomisation
- Uncontrolled seizures
- Sensory or motor neuropathy grade 2 or higher
- Use of potent CYP3A4 inhibitors or inducers
- Pregnancy or breastfeeding
- Unsuitable for neoadjuvant chemotherapy per clinician judgment
- Major surgery within 14 days before starting trial treatment
- Severe or uncontrolled cardiac disease, recent heart attack, or active infections such as hepatitis B, C, or HIV
- ECG with mean QTc over 470 ms on multiple readings or family history of long QT syndrome
- Unable to swallow oral medication or gastrointestinal issues affecting drug absorption
- Known allergy to olaparib, carboplatin, paclitaxel, or their ingredients
- Whole blood transfusions within 120 days before BRCA testing (platelet and red cell transfusions allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 locations
1
Cambridge University Hospitals NHS Foundation Trust & the University of Cambridge
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Actively Recruiting
2
Queen's Hospital
Burton-on-Trent, Derby, United Kingdom, De13 ORB
Actively Recruiting
3
The Christie
Manchester, Lancs, United Kingdom, M20 4GJ
Actively Recruiting
4
Pinderfields General Hospital
Wakefield, Yorkshire, United Kingdom, WF1 4DG
Actively Recruiting
5
University Hospital Ayr
Ayr, United Kingdom, KA6 6DX
Actively Recruiting
6
Basingstoke and North Hampshire Hospital
Basingstoke, United Kingdom, RG24 9NA
Actively Recruiting
7
Bedford General Hospital
Bedford, United Kingdom
Actively Recruiting
8
Royal Bournemouth Hospital
Bournemouth, United Kingdom, BH7 7DW
Actively Recruiting
9
Bristol Haematology & Cancer Centre
Bristol, United Kingdom, BS2 8ED
Actively Recruiting
10
West Suffolk Hospital
Bury St Edmunds, United Kingdom, IP33 2QZ
Actively Recruiting
11
Velindre Cancer Centre
Cardiff, United Kingdom, CF14 2TL
Actively Recruiting
12
Colchester General Hospital
Colchester, United Kingdom, CO4 5JL
Actively Recruiting
13
Russells Hall Hospital
Dudley, United Kingdom, DY1 2HQ
Actively Recruiting
14
Hinchingbrooke Hospital
Huntingdon, United Kingdom, PE29 6NT
Actively Recruiting
15
Ipswich Hospital
Ipswich, United Kingdom, IP4 5PD
Actively Recruiting
16
Kidderminster General Hospital
Kidderminster, United Kingdom, DY11 6RJ
Actively Recruiting
17
University Hospital Crosshouse
Kilmarnock, United Kingdom, KA2 0BE
Actively Recruiting
18
University College London Hospital
London, United Kingdom, NW1 2PG
Actively Recruiting
19
Royal Free Hospital
London, United Kingdom, NW3 2QG
Actively Recruiting
20
Mount Vernon Cancer Centre
Northwood, United Kingdom, HA6 2RN
Actively Recruiting
21
Nottingham City Hospital
Nottingham, United Kingdom, NG5 1PB
Actively Recruiting
22
Churchill Hospital
Oxford, United Kingdom, OX3 7LE
Actively Recruiting
23
Peterborough City Hospital
Peterborough, United Kingdom, PE3 9GZ
Actively Recruiting
24
Poole Hospital
Poole, United Kingdom, BH15 2JB
Actively Recruiting
25
The Alexandra Hopsital
Redditch, United Kingdom, B98 7
Actively Recruiting
26
Queen's Hospital
Romford, United Kingdom, RM7 OAG
Actively Recruiting
27
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
28
Singleton Hospital
Swansea, United Kingdom, SA2 8QA
Actively Recruiting
29
Royal Hampshire County Hospital
Winchester, United Kingdom, SO22 5DG
Actively Recruiting
30
Worcestershire Royal Hospital
Worcester, United Kingdom, WR5 1DD
Actively Recruiting
Research Team
C
CCTC A Cambridge Cancer Trials Centre
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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