Substantially Improving the Cure Rate of High-risk BRCA1-like Breast Cancer

• Status: Recruiting
• Trial end date: 2029-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Investigator-initiated, international, multicentre, randomized, open-label, (neo)adjuvant phase III study in target population (stage III, HER2-negative, BRCA1-like breast cancer patients) comparing optimized standard-dose chemotherapy with intensified, alkylating chemotherapy with stem cell rescue.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Netherlands Cancer Institute
• Treatments: Olaparib

Criteria

Inclusion Criteria:

• Women and men with stage III adenocarcinoma of the breast harboring signs of a breast cancer with features of homologous recombination deficiency (HRD)

• Age of 18-65 years

• The tumor must be HER2-negative

• Treatment must start within 8 weeks after the last surgical resection

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion Criteria:

• Previous radiation therapy

• Previous chemotherapy

• Any previous treatment with a PARP-inhibitor, including olaparib

• Pre-existing neuropathy from any cause in excess of Grade 1

• Chronic concomitant use of known strong or moderate CYP3A inducers