Phase III Randomized, Placebo-Controlled Trial of Endocrine Therapy ± 1 Year of Everolimus in Patients With High-Risk, Hormone Receptor-Positive, Early-Stage Breast Cancer.
Chavez-MacGregor M, Miao J, Pusztai L, Goetz M, Rastogi P, Ganz P, Mamounas E, Paik S, Bandos H, Razaq W, O'Dea A, Kaklamani V, Silber A, Flaum L, Andreopoulou E, Wendt A, Carney J, Sharma P, Gralow J, Lew D, Barlow W, Hortobagyi G. Phase III Randomized, Placebo-Controlled Trial of Endocrine Therapy ± 1 Year of Everolimus in Patients With High-Risk, Hormone Receptor-Positive, Early-Stage Breast Cancer. Journal Of Clinical Oncology 2024, jco2302344. PMID: 38833643, DOI: 10.1200/jco.23.02344.Peer-Reviewed Original ResearchInvasive disease-free survivalHormone receptor-positiveEndocrine therapyOverall survivalBreast cancerHazard ratioReceptor-positiveHigh riskSubset analysisHormone receptor-positive metastatic breast cancerRisk groupsHormone receptor-positive BCEarly-stage breast cancerStratified log-rank testProgression-free survivalEfficacy of everolimusDisease-free survivalMetastatic breast cancerPlacebo-controlled trialSecondary end pointsLog-rank testHighest grade 3Treatment completion ratesPhase IIIEverolimus armDevelopment and validation of RSClin N+ tool for hormone receptor-positive (HR+), HER2-negative (HER2-), node-positive breast cancer.
Pusztai L, Hoag J, Albain K, Barlow W, Stemmer S, Meisner A, Hortobagyi G, Shak S, Hayes D, Rae J, Baehner F, Sharma P, Kalinsky K. Development and validation of RSClin N+ tool for hormone receptor-positive (HR+), HER2-negative (HER2-), node-positive breast cancer. Journal Of Clinical Oncology 2024, 42: 508-508. DOI: 10.1200/jco.2024.42.16_suppl.508.Peer-Reviewed Original ResearchChemoendocrine therapyRecurrence scoreClinicopathological factorsBreast cancerPostmenopausal patientsNode-negative breast cancerNode-positive breast cancerHormone receptor-positiveNode-positive diseaseHR+/HER2- breast cancerRisk estimatesHigh-risk patientsEstimating 5-year riskEstimation of recurrence riskLikelihood ratioPremenopausal patientsHER2-negativeReceptor-positiveChemotherapy benefitEndocrine therapyMenopausal statusRisk patientsInvasive diseasePrognostic informationPostmenopausal model