At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed invasive breast cancer
- ✓ER-negative and HER2-negative breast cancer (TNBC)
- ✓Germline BRCA mutation positive and HER2 negative
- ✓T1, T2, or T3 tumors, or T4 with chest wall/skin involvement or inflammatory carcinoma
- ✕T0 tumor without axillary node >10mm
- ✕TNBC with non-basal phenotype and strong Androgen Receptor expression
- ✕Prior chemotherapy or biological agents for cancer within last 5 years
- ✕Malignancy within last 5 years except non-melanoma skin cancer, in situ cervical cancer, DCIS, stage 1 grade 1 endometrial carcinoma, or curatively treated solid tumors with ≥5 years disease-free survival
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT03150576Phase 3RecruitingUpdate OverdueUpdated 43mo ago · Completion was 25mo agoRandomised, 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.
In Brief
A Phase 3 clinical trial evaluating Olaparib and Paclitaxel and Carboplatin for Breast Cancer. Currently recruiting, targeting 780 participants across 30 sites.
Signals
Detailed 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).
Study Details
Timeline
Interventions
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 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.