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

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.

Timeline

Start

2019-11-06

Primary completion

2025-05-30

Completion

2029-09-30

Publications

• De Caluwe A, Desmoulins I, Cao K, Remouchamps V, Baten A, Longton E, Peignaux K, Joaquin Garcia A, Venet D, Arecco L, Agostinetto E, Nader-Marta G, Denis Z, Dhont J, Kristanto P, Catteau X, Larsimont D, Salgado R, Poortmans P, Stagg J, Sotiriou C, Piccart M, Ignatiadis M, Romano E, Buisseret L. Neoadjuvant stereotactic body radiation therapy with durvalumab and oleclumab in ER+HER2- breast cancer: a randomized phase 2 trial. Nat Med. 2026 Jun 25. doi: 10.1038/s41591-026-04453-z. Online ahead of print.
• De Caluwe A, Romano E, Poortmans P, Gombos A, Agostinetto E, Marta GN, Denis Z, Drisis S, Vandekerkhove C, Desmet A, Philippson C, Craciun L, Veys I, Larsimont D, Paesmans M, Van Gestel D, Salgado R, Sotiriou C, Piccart-Gebhart M, Ignatiadis M, Buisseret L. First-in-human study of SBRT and adenosine pathway blockade to potentiate the benefit of immunochemotherapy in early-stage luminal B breast cancer: results of the safety run-in phase of the Neo-CheckRay trial. J Immunother Cancer. 2023 Dec 6;11(12):e007279. doi: 10.1136/jitc-2023-007279.
• De Caluwe A, Buisseret L, Poortmans P, Van Gestel D, Salgado R, Sotiriou C, Larsimont D, Paesmans M, Craciun L, Stylianos D, Vandekerckhove C, Reyal F, Isabelle V, Eiger D, Piccart M, Romano E, Ignatiadis M. Neo-CheckRay: radiation therapy and adenosine pathway blockade to increase benefit of immuno-chemotherapy in early stage luminal B breast cancer, a randomized phase II trial. BMC Cancer. 2021 Aug 6;21(1):899. doi: 10.1186/s12885-021-08601-1.

Drugs

Indications