Neo-adjuvant Chemotherapy Combined With Stereotactic Body Radiotherapy to the Primary Tumour +/- Durvalumab, +/- Oleclumab in Luminal B Breast Cancer:

• Status: Recruiting
• Trial end date: 2025-10-15

Summary

Neo-CheckRay is a multicenter, open-label phase II study that randomizes luminal B breast cancer subjects candidate for neo-adjuvant chemotherapy in a 1:1:1 ratio in 3 arms:

1. the combination of weekly paclitaxel followed by dose-dense doxorubicin-cyclophosphamide (ddAC) and pre-operative radiation therapy (boost dose) on the primary tumour

2. arm 1 with the addition of the anti-PD-L1 antibody durvalumab

3. arm 2 with the addition of the anti-CD73 antibody oleclumab The primary tumour will be excised 2-6 weeks after completion of ddAC. A safety run-in is planned for the 6 first subjects before starting the randomized phase II trial. Those 6 subjects will receive the treatment given in Arm 3.

• Phase: Phase 2

Details

• Lead Sponsor: Jules Bordet Institute
• Collaborators: AstraZeneca; Institut Curie
• Treatments: Antibodies, Monoclonal; Durvalumab; Phenobarbital