Clinical Trial

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

Study acronym: Neo-CheckRay

Active, Not Recruiting Phase 2

Record status

This record was last updated December 20, 2024 (before its estimated May 30, 2025 completion). Its status may not reflect the trial's current state.

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.

Protocol Amendment History 15 amendments

This ClinicalTrials.gov record has been amended 15 times since 2019-03-12; most recent amendment 2024-12-18.

Status change: Recruiting → Active, Not Recruiting 2024-03-13

Status change: Active, Not Recruiting → Recruiting 2021-10-07

Status change: Recruiting → Active, Not Recruiting 2020-06-08

Status change: Not Yet Recruiting → Recruiting 2019-10-21

Trial Details

NCT Number	NCT03875573
Lead Sponsor	Jules Bordet Institute Collaborators: Institut Curie, AstraZeneca
Conditions	Luminal B
Enrollment	147 participants
Start Date	2019-11-06
Primary Completion	2025-05-30 (estimated)
Study Completion	2029-09-30 (estimated)
Updated on ClinicalTrials.gov	2024-12-20