2024
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, 42: 3012-3021. PMID: 38833643, PMCID: PMC11565489, 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 arm
2021
A Randomized Trial of Fulvestrant, Everolimus, and Anastrozole for the Front-line Treatment of Patients with Advanced Hormone Receptor–positive Breast Cancer, SWOG S1222SWOG S1222
Moore HCF, Barlow WE, Somlo G, Gralow JR, Schott AF, Hayes DF, Kuhn P, Hicks JB, Welter L, Dy PA, Yeon CH, Conlin AK, Balcueva E, Lew DL, Tripathy D, Pusztai L, Hortobagyi GN. A Randomized Trial of Fulvestrant, Everolimus, and Anastrozole for the Front-line Treatment of Patients with Advanced Hormone Receptor–positive Breast Cancer, SWOG S1222SWOG S1222. Clinical Cancer Research 2021, 28: 611-617. PMID: 34844978, PMCID: PMC9782801, DOI: 10.1158/1078-0432.ccr-21-3131.Peer-Reviewed Original ResearchConceptsProgression-free survivalHER2-negative breast cancerFirst-line treatmentBreast cancerAdvanced hormone receptor-positive breast cancerAdvanced hormone-sensitive breast cancerHER2-negative advanced breast cancerHormone receptor-positive breast cancerHormone-sensitive breast cancerRandomized placebo-controlled trialReceptor-positive breast cancerCombination endocrine therapyMetastatic hormone receptorPlacebo-controlled trialAdvanced breast cancerMainstay of treatmentFront-line treatmentBaseline CTCsEndocrine therapyEndocrine treatmentPostmenopausal womenMetastatic diseaseOverall survivalPrognostic impactSystemic therapy