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
Sponsors and collaborators
Cambridge University Hospitals NHS Foundation Trust
Lead sponsor
University of Cambridge
Sponsor institution
AstraZeneca
Collaborator
Cancer Research UK
Collaborator