At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Olaparib (drug), Paclitaxel and Carboplatin (drug)
- How long the study runs
- Study runs about 217 months (dates as stated)
- About the drug or intervention
- Olaparib — drug: Patients will self-administer Olaparib by mouth. · Paclitaxel and Carboplatin — drug: Paclitaxel I.V.
- Patient visit burden
- Not specified by the sponsor
In plain English
This trial, run by Cambridge University Hospitals NHS Foundation Trust, is looking at breast cancer treatment before surgery (called neoadjuvant treatment). It involves people with triple negative breast cancer, or breast cancer linked to a faulty BRCA gene passed down in families. The trial uses a platinum chemotherapy drug together with a drug called a polyadenosine 5'diphosphoribose polymerisation inhibitor (a type of PARP inhibitor).
Who can take part
- Aged between 16 and 70
- Have invasive breast cancer confirmed by laboratory tests
- Triple negative breast cancer (negative for ER and HER2, with any PR status but it must be scored), OR a faulty BRCA gene inherited from a parent (germline BRCA), with HER2-negative cancer and any ER or PR status
- Tumour is T1, T2 or T3, or is a T4 tumour (growing into the chest wall or skin), or inflammatory cancer, or other locally advanced disease such as cancer in large or fixed lymph nodes under the arm or near the collarbone, or a multifocal tumour with at least one tumour larger than 10mm
- Cancer in both breasts is allowed if both meet the criteria
- Fit enough for the chemotherapy, with good bone marrow, liver and kidney function, and an activity level (performance status) of 0 or 1
- Treatment starts within 6 weeks of the diagnostic biopsy (up to 9 weeks in some cases if medically acceptable)
- Tests done on the tumour sample are available, including the tumour infiltrating lymphocytes score and CK 5/6 and EGFR (and possibly androgen receptor) scores, plus stored tissue samples from the biopsy and later surgery
- Not pregnant or breastfeeding, and willing to use effective contraception during the trial and for at least 6 months after the last dose
Who may not be able to
- No tumour found in the breast and no enlarged lymph node over 10mm
- Triple negative breast cancer that strongly expresses the androgen receptor (a non-basal type)
- Chemotherapy or biological cancer treatment in the last 5 years
- Any other cancer in the last 5 years (with some exceptions, such as treated skin cancer, treated early cervical cancer, DCIS, certain treated endometrial cancer, or other cancers cured at least 5 years ago)
- Myelodysplastic syndrome or acute myeloid leukaemia
- Signs the cancer has already spread to other parts of the body before joining the trial
- Uncontrolled seizures
- Existing nerve damage (numbness, tingling or weakness) of grade 2 or worse
- Taking certain medicines known as strong CYP3A4 inhibitors or inducers
- Pregnant or breastfeeding
- Not suitable for chemotherapy before surgery, in the doctor's opinion
- Major surgery within 14 days of starting, or not yet recovered from surgery
- Severe or uncontrolled illness that would prevent finishing treatment or follow-up, such as serious heart disease, a recent heart attack (within 12 months), or active infection including hepatitis B, hepatitis C or HIV
- A heart tracing (ECG) showing a long QTc (over 470 milliseconds) on two or more readings in 24 hours, or a family history of long QT syndrome
- Unable to swallow tablets, or a gut problem that might stop the medicine being absorbed
- Allergic reaction to olaparib, carboplatin, paclitaxel or their ingredients (including cremophor)
- A whole blood transfusion in the last 120 days before the BRCA blood test (packed red cells and platelet transfusions are acceptable)
What taking part involves
- • Treatment before surgery (neoadjuvant treatment) with a platinum chemotherapy drug and a PARP inhibitor
- • The drugs named in the trial include olaparib, carboplatin and paclitaxel
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 16 Years to 70 Years
- Who
- All
- Number of participants
- 780
- Started
- 2016-05
- Last checked
- 2022-11
Plain English Summary
What is this study?
- • Testing a new treatment for breast cancer
- • Phase2/Phase3 - 780 participants
- • 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)
Who can take part?
- • Ages 16 Years to 70 Years
- • Diagnosed with breast cancer
Where?
- • Cambridge - Cambridge University Hospitals NHS Foundation Trust & the University of Cambridge
- • Burton-on-Trent - Queen's Hospital
- • Manchester - The Christie
- • Wakefield - Pinderfields General Hospital
- • +26 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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).
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 16 Years - 70 Years
- Who can join: All genders
- How fit you need to be: ECOG 0 or better
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ a negative serum or urine pregnancy test within 14 days
What the study is looking for
- ✓Aged between 16 and 70.
- ✓Written agreement to take part, willing and able to comply with the Protocol for the duration of the trial including...
- ✓confirmed by a biopsy invasive breast cancer.
- ✓ER-negative\*, and HER2-negative\*\* breast cancer (TNBC). Patients will be eligible with any PR status but PR...
- ✓Germline BRCA (gBRCA) mutation positive, HER2 negative, and PgR / ER of any status.
Who cannot take part
- ✗T0 tumour in absence of axillary node \>10mm.
- ✗TNBC with a non-basal phenotype which strongly expresses Androgen Receptor.
- ✗Previous or concomitant drug treatment or biological agents used for the treatment of cancer in the last 5 years.
- ✗Patients with myelodysplastic syndrome/acute myeloid leukaemia.
- ✗Evidence of distant metastasis apparent prior to randomisation.
See the full criteria
Where Is This Study? (30 UK sites)
Cambridge University Hospitals NHS Foundation Trust & the University of Cambridge
Cambridge CB2 0QQ, United Kingdom
Queen's Hospital
Burton-on-Trent De13 ORB, United Kingdom
The Christie
Manchester M20 4GJ, United Kingdom
Pinderfields General Hospital
Wakefield WF1 4DG, United Kingdom
University Hospital Ayr
Ayr KA6 6DX, United Kingdom
Basingstoke and North Hampshire Hospital
Basingstoke RG24 9NA, United Kingdom
Bedford General Hospital
Bedford, United Kingdom
Royal Bournemouth Hospital
Bournemouth BH7 7DW, United Kingdom
Bristol Haematology & Cancer Centre
Bristol BS2 8ED, United Kingdom
West Suffolk Hospital
Bury St Edmunds IP33 2QZ, United Kingdom
Velindre Cancer Centre
Cardiff CF14 2TL, United Kingdom
Colchester General Hospital
Colchester CO4 5JL, United Kingdom
Russells Hall Hospital
Dudley DY1 2HQ, United Kingdom
Hinchingbrooke Hospital
Huntingdon PE29 6NT, United Kingdom
Ipswich Hospital
Ipswich IP4 5PD, United Kingdom
Kidderminster General Hospital
Kidderminster DY11 6RJ, United Kingdom
University Hospital Crosshouse
Kilmarnock KA2 0BE, United Kingdom
University College London Hospital
London NW1 2PG, United Kingdom
Royal Free Hospital
London NW3 2QG, United Kingdom
Mount Vernon Cancer Centre
Northwood HA6 2RN, United Kingdom
Nottingham City Hospital
Nottingham NG5 1PB, United Kingdom
Churchill Hospital
Oxford OX3 7LE, United Kingdom
Peterborough City Hospital
Peterborough PE3 9GZ, United Kingdom
Poole Hospital
Poole BH15 2JB, United Kingdom
The Alexandra Hopsital
Redditch B98 7, United Kingdom
Queen's Hospital
Romford RM7 OAG, United Kingdom
Southampton General Hospital
Southampton SO16 6YD, United Kingdom
Singleton Hospital
Swansea SA2 8QA, United Kingdom
Royal Hampshire County Hospital
Winchester SO22 5DG, United Kingdom
Worcestershire Royal Hospital
Worcester WR5 1DD, United Kingdom
How to Get in Touch
CCTC A Cambridge Cancer Trials Centre
Sponsor contactCONTACT
