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

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age16-70
SponsorCambridge University Hospitals NHS Foundation Trust

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Olaparib
  • Paclitaxel and Carboplatin

Treatment groups

780 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Cambridge University Hospitals NHS Foundation Trust

Lead sponsor

University of Cambridge

Sponsor institution

AstraZeneca

Collaborator

Cancer Research UK

Collaborator