Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 7, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT03875573). This is a study registration, not published results. Lead sponsor: Jules Bordet Institute. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 147 participants (ACTUAL). Conditions: Luminal B. Interventions: DRUG: Durvalumab; RADIATION: Stereotactic Body Radiotherapy; DRUG: Oleclumab. Primary outcome measures: Safety Run-in: Evaluation of the immune related or radiation therapy related toxicity of special interest , 7 months; Safety Run-in: Evaluation of the feasibility of the primary surgery , 7 months; Phase II: Demonstration of the tumour response in arms 2 or 3 versus arm 1 , 24 months. 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.