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- Title
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.
- Authors
De Caluwé, Alex; Buisseret, Laurence; Poortmans, Philip; Van Gestel, Dirk; Salgado, Roberto; Sotiriou, Christos; Larsimont, Denis; Paesmans, Marianne; Craciun, Ligia; Stylianos, Drisis; Vandekerckhove, Christophe; Reyal, Fabien; Isabelle, Veys; Eiger, Daniel; Piccart, Martine; Romano, Emanuela; Ignatiadis, Michail
- Abstract
<bold>Background: </bold>Residual breast cancer after neo-adjuvant chemotherapy (NACT) predicts disease outcome and is a surrogate for survival in aggressive breast cancer (BC) subtypes. Pathological complete response (pCR) rate, however, is lower for luminal B BC in comparison to the triple negative (TNBC) and HER2+ subtypes. The addition of immune checkpoint blockade (ICB) to NACT has the potential to increase pCR rate but is hampered by the lower immunogenicity of luminal B BC. Novel strategies are needed to stimulate the immune response and increase the response rate to ICB in luminal B BC.<bold>Methods: </bold>The Neo-CheckRay trial is a randomized phase II trial investigating the impact of stereotactic body radiation therapy (SBRT) to the primary breast tumor in combination with an anti-CD73 (oleclumab) to increase response to anti PD-L1 (durvalumab) and NACT. The trial is designed as a three-arm study: NACT + SBRT +/- durvalumab +/- oleclumab. The result at surgery will be evaluated using the residual cancer burden (RCB) index as the primary endpoint. Six patients will be included in a safety run-in, followed by a randomized phase II trial that will include 136 evaluable patients in 3 arms. Inclusion is limited to luminal B breast cancers that are MammaPrint genomic high risk.<bold>Discussion: </bold>combination of ICB with chemotherapy in luminal B BC might benefit from immune priming agents to increase the response rate. As none have been identified so far, this phase II trial will evaluate SBRT and oleclumab as potential immune priming candidates.<bold>Trial Registration: </bold>trial registered on ClinicalTrials.gov ( NCT03875573 ) on March 14th, 2019.
- Subjects
BREAST cancer; STEREOTACTIC radiotherapy; IMMUNE checkpoint proteins; RADIOTHERAPY; TUMOR classification; NEOADJUVANT chemotherapy; ADENOSINES; EXPERIMENTAL design; RESEARCH; RESEARCH methodology; METABOLISM; MEDICAL cooperation; EVALUATION research; MEDICAL protocols; RANDOMIZED controlled trials; COMPARATIVE studies; COMBINED modality therapy; STATISTICAL sampling; BREAST tumors; PHYSIOLOGICAL effects of radiation
- Publication
BMC Cancer, 2021, Vol 21, Issue 1, p1
- ISSN
1471-2407
- Publication type
journal article
- DOI
10.1186/s12885-021-08601-1