2025
Neoadjuvant nivolumab and chemotherapy in early estrogen receptor-positive breast cancer: a randomized phase 3 trial
Loi S, Salgado R, Curigliano G, Romero Díaz R, Delaloge S, Rojas García C, Kok M, Saura C, Harbeck N, Mittendorf E, Yardley D, Suárez Zaizar A, Caminos F, Ungureanu A, Reinoso-Toledo J, Guarneri V, Egle D, Ades F, Pacius M, Chhibber A, Chandra R, Nathani R, Spires T, Wu J, Pusztai L, McArthur H. Neoadjuvant nivolumab and chemotherapy in early estrogen receptor-positive breast cancer: a randomized phase 3 trial. Nature Medicine 2025, 1-9. PMID: 39838118, DOI: 10.1038/s41591-024-03414-8.Peer-Reviewed Original ResearchPathological complete responseIncreased pCR ratePhase 3 trialNeoadjuvant chemotherapyBreast cancerER+/HER2- BCNivolumab armPCR rateAnti-programmed death 1 agentsDouble-blind phase 3 trialEndpoint of pathologic complete responseStromal tumor-infiltrating lymphocyte levelsProgrammed death-ligand 1 expressionEstrogen receptor-positive breast cancerLower pathologic complete responseTumor-infiltrating lymphocyte levelsRandomized phase 3 trialReceptor-positive breast cancerHigh riskLigand 1 expressionEstrogen receptor-positivePrimary breast cancerTaxane-based chemotherapyDense lymphocytic infiltrateT cell immunosurveillance
2020
A phase III trial of nivolumab with neoadjuvant chemotherapy and adjuvant endocrine therapy in ER+/HER2- primary breast cancer: CheckMate 7FL.
Loi S, McArthur H, Harbeck N, Pusztai L, Delaloge S, Letrent K, Chen T, Li B, Tatsuoka K, Zardavas D, Curigliano G. A phase III trial of nivolumab with neoadjuvant chemotherapy and adjuvant endocrine therapy in ER+/HER2- primary breast cancer: CheckMate 7FL. Journal Of Clinical Oncology 2020, 38: tps604-tps604. DOI: 10.1200/jco.2020.38.15_suppl.tps604.Peer-Reviewed Original ResearchAdjuvant endocrine therapyPathologic complete responsePrimary breast cancerEndocrine therapyNeoadjuvant chemotherapyBreast cancerNeoadjuvant phaseER expressionGlobal phase 3 studyDeath ligand 1 (PD-L1) expressionLong-term clinical outcomesAdequate organ functionDeath-1 (PD-1) inhibitionLow ER expressionAxillary nodal statusDisease-free survivalEvent-free survivalLigand 1 expressionPhase III trialsResidual cancer burdenPhase 3 studyOverall response rateRisk of relapseValid surrogate endpointQuality of life