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Breast CancerPhase 2/3PARTNERNCT03150576

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

A Phase 2/3 study testing Olaparib and Paclitaxel and Carboplatin in people with Breast Cancer, run by Cambridge University Hospitals NHS Foundation Trust at 30 sites in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 16 to 70 years
Conditions the study is for
Breast Cancer
What is being tested?
Olaparib and Paclitaxel and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
780 participants
Where
30 sitesUnited Kingdom
Study dates
May 2016to Jun 2034
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Aged between 16 and 70.
  • Written informed consent, willing and able to comply with the Protocol for the duration of the trial including undergoing treatment and scheduled visits and examinations.
  • Histologically confirmed invasive breast cancer.
  • ER-negative*, and HER2-negative** breast cancer (TNBC). Patients will be eligible with any PR status but PR expression must be scored.
  • OR
  • Germline BRCA (gBRCA) mutation positive, HER2 negative, and PgR / ER of any status.
Show all 23Show fewer
  • T1, T2 or T3 tumours.
  • T4 tumour of any size with direct extension to (a) chest wall or (b) skin. OR Inflammatory carcinoma with tumour of any size. OR
  • Other Locally Advanced Disease:
  • Involvement of ipsilateral large or fixed axillary lymph nodes, or infra or supraclavicular nodes (>10mm diameter or clinical N2 or N3) and primary breast tumour of any diameter.
  • Involvement of ipsilateral large or fixed axillary lymph nodes, or infra or supraclavicular nodes (>10mm diameter, or clinical N2 or N3), without a primary breast tumour identified, the presence of breast cancer in a Lymph Node (LN) must be histopathologically confirmed by LN biopsy.
  • OR
  • Multifocal tumour:
  • with at least one tumour with a size>10mm.
  • Patients with bilateral disease are eligible to enter the trial provided that both breast disease meets the above criteria.
  • Be fit to receive the trial chemotherapy regimen in the opinion of the responsible clinician:
  • Adequate bone marrow, hepatic, and renal function. ECOG performance status of 0, or 1.
  • Treatment should be commenced within 6 weeks of the diagnostic biopsy. In uncommon circumstances, where medically acceptable, treatment is permitted to start within a maximum of 9 weeks of the diagnostic biopsy.
  • Availability of the Tumour Infiltrating Lymphocytes score is required.
  • Availability of CK 5/6 and EGFR +/- Androgen Receptor IHC score.
  • Availability of slides and paraffin embedded tissue blocks from pre-chemotherapy core biopsy and from primary surgical resection is required.
  • Women of child-bearing potential (WCBP), defined as not surgically sterilized or not post-menopausal for at least 24 consecutive months if age ≤55 year or 12 months if age >55 years, must have a negative serum or urine pregnancy test within 14 days prior to randomisation.
  • All WCBP and all sexually active male patients as well as their partners must be aware that they should not conceive during the treatment period and therefore should routinely use effective forms of contraception, throughout their participation in the trial and for at least 6 months after the last dose of trial treatment. Please follow the olaparib contraception guidelines.

Who cannot join

  • T0 tumour in absence of axillary node >10mm.
  • TNBC with a non-basal phenotype which strongly expresses Androgen Receptor.
  • Previous or concomitant chemotherapy or biological agents used for the treatment of cancer in the last 5 years.
  • Malignancy within the last 5 years except: adequately treated non-melanoma skin cancer; curatively treated in situ cancer of the cervix; ductal carcinoma in situ (DCIS); Stage 1, grade 1 endometrial carcinoma; or other solid tumours including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥5 years.
  • Patients with myelodysplastic syndrome/acute myeloid leukaemia.
  • Evidence of distant metastasis apparent prior to randomisation.
Show all 18Show fewer
  • Patients with uncontrolled seizures.
  • Pre-existing sensory or motor neuropathy of CTCAE v4.03, grade ≥2.
  • Concomitant use of known potent CYP3A4 inhibitors and inducers. Consider wash-out periods.
  • Pregnant or breast feeding women.
  • Not suitable for neoadjuvant chemotherapy in the opinion of the responsible clinician.
  • Major surgery within 14 days of starting trial treatment and patients must have recovered from any effects of any major surgery.
  • Any evidence of other disease or any concomitant medical or psychiatric problems which in the opinion of the Investigator would prevent completion of treatment or follow-up. For example:
  • Evidence of severe or uncontrolled cardiac disease Uncontrolled ventricular arrhythmia Recent myocardial infarction (within 12 months) Active infection including Hepatitis B, Hepatitis C and Human Immunodeficiency virus (HIV). Screening for chronic conditions is not required.
  • ECG with mean resting QTc >470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome.
  • Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the trial medication
  • Known hypersensitivity to olaparib, carboplatin, paclitaxel or their excipients (including cremophor).
  • Whole blood transfusions in the last 120 days prior to blood sampling for BRCA test as it may interfere with the results (packed red blood cells and platelet transfusions are acceptable).

Trial locations and contacts

30 sites in 1 country. Contact the study team or a site near you to ask about taking part.

CCTC A Cambridge Cancer Trials Centre contact

+44 (0)1223 348071

cuh.partner@nhs.net

30 sites in 1 country

United Kingdom30 sites, 30 recruiting

  • University Hospital Ayr

    Ayr, KA6 6DX

    First Contact, 01563 825858

    Lucy Scott

    Recruiting

  • Basingstoke and North Hampshire Hospital

    Basingstoke, RG24 9NA

    First Contact, 01256 473202

    Sanjay Raj

    Recruiting

  • Bedford General Hospital

    Bedford

    First Contact, 01234 795924

    Shahzeena Aslam

    Recruiting

  • Royal Bournemouth Hospital

    Bournemouth, BH7 7DW

    First Contact, 01202704773

    Maria Cidon

    Recruiting

  • Bristol Haematology & Cancer Centre

    Bristol, BS2 8ED

    First Contact, 0117 342 6736

    Jeremy Braybrooke

    Recruiting

  • Queen's Hospital

    Burton-on-Trent, Derby, De13 ORB

    First Contact, 01283 511511

    Mojca Persic

    Recruiting

  • West Suffolk Hospital

    Bury St Edmunds, IP33 2QZ

    First Contact, 01284 712763

    Margaret Moody

    Recruiting

  • Cambridge University Hospitals NHS Foundation Trust & the University of Cambridge

    Cambridge, Cambridgeshire, CB2 0QQ

    CCTC Cambridge Cancer Trials Centre, +44(0) 1223 348071

    Jean Abraham

    Recruiting

  • Velindre Cancer Centre

    Cardiff, CF14 2TL

    First Contact, 02920615888

    Annabel Borley

    Recruiting

  • Colchester General Hospital

    Colchester, CO4 5JL

    First Contact, 01206 745 355

    MB Mukesh

    Recruiting

  • Russells Hall Hospital

    Dudley, DY1 2HQ

    First Contact, 01384 456111

    Devanshi Tripathi

    Recruiting

  • Hinchingbrooke Hospital

    Huntingdon, PE29 6NT

    Cheryl Palmer

    Recruiting

  • Ipswich Hospital

    Ipswich, IP4 5PD

    Ramachandran Venkitaraman

    Recruiting

  • Kidderminster General Hospital

    Kidderminster, DY11 6RJ

    First Contact, 01562 513275

    Mark Churn

    Recruiting

  • University Hospital Crosshouse

    Kilmarnock, KA2 0BE

    First Contact, 01563 825858

    Lucy Scott

    Recruiting

  • University College London Hospital

    London, NW1 2PG

    First Contact, 02034474741

    Rebecca Roylance

    Recruiting

  • Royal Free Hospital

    London, NW3 2QG

    First Contact, 0207 794 0500

    Jackie Newby

    Recruiting

  • The Christie

    Manchester, Lancs, M20 4GJ

    First Contact, 0161 446 3000

    Anne Armstrong

    Recruiting

  • Mount Vernon Cancer Centre

    Northwood, HA6 2RN

    Stephanie Sutherland

    Recruiting

  • Nottingham City Hospital

    Nottingham, NG5 1PB

    First Contact, 0115 969 1169

    Stephen Chan

    Recruiting

  • Churchill Hospital

    Oxford, OX3 7LE

    First Contact, 01865 572025

    Nicola Levitt

    Recruiting

  • Peterborough City Hospital

    Peterborough, PE3 9GZ

    First Contact, 01733 673167

    Karen McAdam

    Recruiting

  • Poole Hospital

    Poole, BH15 2JB

    Amit Chakrabarti

    Recruiting

  • The Alexandra Hopsital

    Redditch, B98 7

    First Contact, 01527 505788

    Mark Churn

    Recruiting

  • Queen's Hospital

    Romford, RM7 OAG

    First Contact, 01708 435297

    Emma Staples

    Recruiting

  • Southampton General Hospital

    Southampton, SO16 6YD

    First Contact, 02381 204618

    Ellen Copson

    Recruiting

  • Singleton Hospital

    Swansea, SA2 8QA

    David Davies

    Recruiting

  • Pinderfields General Hospital

    Wakefield, Yorkshire, WF1 4DG

    First Contact, 01924 542486

    Sreedevi Kumar

    Recruiting

  • Royal Hampshire County Hospital

    Winchester, SO22 5DG

    First Contact, 01962 824634

    Sanjay Raj

    Recruiting

  • Worcestershire Royal Hospital

    Worcester, WR5 1DD

    First Contact, 01905 733194

    Mark Churn

    Recruiting

Other trials in United Kingdom

About this study

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.

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).

Read the 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.

Conditions
Breast Cancer
Being tested
Olaparib, Paclitaxel and Carboplatin
Keywords
Triple negative breast cancer, germline BRCA, platinum and PARP inhibitor, neoadjuvant chemotherapy, olaparib
Medical subject headings
Breast Neoplasms, Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OlaparibDrug

    Also called Lynparza

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

  • Paclitaxel and CarboplatinDrug

    Also called Taxol and Paraplatin

    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.

Study groups in NCT03150576
Study groupRoleWhat they receive
ControlActive comparator4 cycles of: Paclitaxel 80mg/m2 Day 1, 8 \& 15, every 3 weeks, Carboplatin area under the curve (AUC) 5 Day 1, every 3 weeks
Receives: Drug: Paclitaxel and Carboplatin
Research 1Experimental4 cycles of: Paclitaxel 80mg/m2 on Days 1, 8 \& 15 every 3 weeks, Carboplatin AUC 5 Day 1, every 3 weeks, Olaparib oral 150mg twice daily, Day -2 to Day 10 every 3 weeks
Receives: Drug: Olaparib; Drug: Paclitaxel and Carboplatin
Research 2Experimental4 cycles of: Paclitaxel 80mg/m2 on Days 1, 8 \& 15 every 3 weeks, Carboplatin AUC 5 Day 1, every 3 weeks, Olaparib oral 150mg twice daily, Day 3 to Day 14 every 3 weeks
Receives: Drug: Olaparib; Drug: Paclitaxel and Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stage 1 - Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.03.

    Primary outcome measure - safety of the addition of olaparib to three weekly carboplatin/weekly paclitaxel chemotherapy.

    Measured: 1 year - when first 25 patients in each research arm who had received at least one dose of Olaparib protocol treatment have completed their protocol treatment.

  2. Stage 2 - pCR rate and completion rate of Olaparib treatment as per protocol.

    Primary outcome measure - pCR in each of the two research arms. At the end of stage 2, one of the research treatments will be dropped using the 'pick the winner' method.

    Measured: 15 months - when pathological complete response (pCR) is available for 53 patients in each of two research arms.

  3. Stage 3 - Efficacy analysis based on pCR at surgery. To be assessed by central review of pathology reports.

    Primary outcome measure - pCR at surgery after neoadjuvant treatment. pCR rates after neoadjuvant chemotherapy +/- olaparib, defined as no residual invasive carcinoma within the breast (Ductal Carcinoma in situ permitted) AND no evidence of metastatic disease within the lymph nodes.

    Measured: 5.5 years - October 2021 approx.

Secondary outcomes (13)

  1. pCR at surgery - assessed by review of histopathology slides

    pCR at surgery assessed by central pathology review of the diagnosis and surgery slides.

    Measured: Up to 2 years after last patient randomised

  2. PARTNERing Pathway

    For those patients who still have residual disease after receiving neoadjuvant chemotherapy there is the opportunity to receive a further two cycles of Duralumab and AZD6738. Durvalumab I.V will be administered on cycle 1, day 1 and cycle 2, day 1. AZD6738 will be self administered by patients by mouth twice a day for 7 days beginning on cycle 1, day 22 and cycle 2, day 22.

    Measured: 2 cycles (each lasting 28 days)

  3. Relapse-Free Survival (RFS)

    Relapse Free Survival (RFS), calculated from date of randomisation to date of first relapse or date of death from all causes, whichever occurs first.

    Measured: Up to 10 years after last patient is randomised

  4. Breast cancer specific survival (BCSS)

    Breast cancer specific survival (BCSS), calculated from date of randomisation to date of death from breast cancer.

    Measured: Up to 10 years after last patient is randomised

  5. Distant disease-free survival

    Distant disease-free survival, calculated from date of randomisation to date of the first distant disease relapse or date of death from all causes, whichever occurs first.

    Measured: Up to 10 years after last patient is randomised

  6. Local recurrence-free survival

    Local recurrence-free survival, calculated from date of randomisation to date of the first local recurrence or date of death from all causes, whichever occurs first.

    Measured: Up to 10 years after last patient is randomised

  7. Overall survival (OS)

    Overall survival (OS), calculated from date of randomisation to date of death from all causes.

    Measured: Up to 10 years after last patient is randomised

  8. Time to second cancer (TTSC)

    Time to second cancer (TTSC), calculated from the date of randomisation to the date of diagnosis of second cancer.

    Measured: Up to 10 years after last patient is randomised

  9. pCR in breast alone

    pCR in breast alone

    Measured: Up to 2 years after last patient is randomised

  10. Residual Cancer Burden (RCB)

    Residual Cancer Burden (RCB) I-III will be assessed by central pathology review.

    Measured: Up to 10 years after last patient is randomised

  11. Radiological response - as assessed by radiological response criteria as per RECIST v1.1

    Radiological response after 4th and final cycles

    Measured: Up to 2 years after last patient is randomised

  12. Treatment related toxicities - as assessed by CTCAE v4.03

    Treatment related toxicities

    Measured: Up to 10 years after last patient is randomised

  13. Quality of Life Questionnaire

    Quality of Life (sub-study). Questionnaire to be completed by patient prior to start of treatment, following cycle 4 and cycle 7, following surgery and then annually for two years to document long-term effects on quality of life.

    Measured: Up to 10 years after last patient is randomised

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2017
  2. Study startMay 2016
  3. Primary completionJun 2024 (estimated)
  4. Study completionJun 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
780 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03150576
Sponsor's protocol ID
PARTNER
Acronym
PARTNER
Status last verified
Nov 2022
First submitted
26 Jul 2016
Last updated
14 Nov 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: All Clinical Trial data will be considered to be shared on formal application to the Trial CI \& TMG, however data affecting or considered as having the potential to affect the integrity or the endpoints of the trial and/or other collaborations will not be shared (or until such time that they no longer are deemed to have an effect).

Publications

  • Abraham JE, O'Connor LO, Grybowicz L, Alba KP, Dayimu A, Demiris N, Harvey C, Drewett LM, Lucey R, Fulton A, Roberts AN, Worley JR, Chhabra MA, Qian W, Brown J, Hardy R, Vallier AL, Chan S, Cidon MEU, Sherwin E, Chakrabarti A, Sadler C, Barnes J, Persic M, Smith S, Raj S, Borley A, Braybrooke JP, Staples E, Scott LC, Palmer CA, Moody M, Churn MJ, Pilger D, Zagnoli-Vieira G, Wijnhoven PWG, Mukesh MB, Roylance RR, Schouten PC, Levitt NC, McAdam K, Armstrong AC, Copson ER, McMurtry E, Galbraith S, Tischkowitz M, Provenzano E, O'Connor MJ, Earl HM; PARTNER Trial Group. Neoadjuvant PARP inhibitor scheduling in BRCA1 and BRCA2 related breast cancer: PARTNER, a randomized phase II/III trial. Nat Commun. 2025 May 13;16(1):4269. doi: 10.1038/s41467-025-59151-0.

    PubMed 40360463

  • Abraham JE, Pinilla K, Dayimu A, Grybowicz L, Demiris N, Harvey C, Drewett LM, Lucey R, Fulton A, Roberts AN, Worley JR, Chhabra A, Qian W, Vallier AL, Hardy RM, Chan S, Hickish T, Tripathi D, Venkitaraman R, Persic M, Aslam S, Glassman D, Raj S, Borley A, Braybrooke JP, Sutherland S, Staples E, Scott LC, Davies M, Palmer CA, Moody M, Churn MJ, Newby JC, Mukesh MB, Chakrabarti A, Roylance RR, Schouten PC, Levitt NC, McAdam K, Armstrong AC, Copson ER, McMurtry E, Tischkowitz M, Provenzano E, Earl HM. The PARTNER trial of neoadjuvant olaparib with chemotherapy in triple-negative breast cancer. Nature. 2024 May;629(8014):1142-1148. doi: 10.1038/s41586-024-07384-2. Epub 2024 Apr 8.

    PubMed 38588696

  • Woitek R, McLean MA, Ursprung S, Rueda OM, Manzano Garcia R, Locke MJ, Beer L, Baxter G, Rundo L, Provenzano E, Kaggie J, Patterson A, Frary A, Field-Rayner J, Papalouka V, Kane J, Benjamin AJV, Gill AB, Priest AN, Lewis DY, Russell R, Grimmer A, White B, Latimer-Bowman B, Patterson I, Schiller A, Carmo B, Slough R, Lanz T, Wason J, Schulte RF, Chin SF, Graves MJ, Gilbert FJ, Abraham JE, Caldas C, Brindle KM, Sala E, Gallagher FA. Hyperpolarized Carbon-13 MRI for Early Response Assessment of Neoadjuvant Chemotherapy in Breast Cancer Patients. Cancer Res. 2021 Dec 1;81(23):6004-6017. doi: 10.1158/0008-5472.CAN-21-1499. Epub 2021 Oct 8.

    PubMed 34625424

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Olaparib and Paclitaxel and Carboplatin in people with Breast Cancer, run by Cambridge University Hospitals NHS Foundation Trust at 30 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact CCTC A Cambridge Cancer Trials Centre (+44 (0)1223 348071, cuh.partner@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stage 1 - Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.03. (time frame: 1 year - when first 25 patients in each research arm who had received at least one dose of Olaparib protocol treatment have completed their protocol treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03150576, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.

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