OncRef

Clinical Trial: NCT03875573

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 2

Lead Sponsor:Jules Bordet Institute
Information Provided By:Jules Bordet Institute
Last Update Posted:2026-10-07

Study Overview

Brief 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.

Official Title

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

Conditions

Luminal B

Intervention / Treatment

  • Drug: Durvalumab
  • Radiation: Stereotactic Body Radiotherapy
  • Drug: Oleclumab

Other Study ID Numbers

  • IJB-LBC-NEOCHECKRAY-2018

Start Date (Actual)

2019-11-06

Primary Completion Date (Actual)

2024-11-30

Study Completion Date (Estimated)

2029-09-30

Enrollment (Actual)

147

Study Type

Interventional

Phase

Phase 2