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
2019
P359 Phase III randomized, placebo-controlled clinical trial evaluating the use of adjuvant endocrine therapy±everolimusin patients with high-risk, hormone receptor (HR) positive, HER2-negative breast cancer (BC): SWOG/NRG/Alliance S1207 (NCT01674140)
Chavez-Macgregor M, Barlow W, Pusztai L, Rastogi P, Ganz P, Mamounas E, Bandos H, Miao J, Gralow J, Hortobagyi G, investigators S. P359 Phase III randomized, placebo-controlled clinical trial evaluating the use of adjuvant endocrine therapy±everolimusin patients with high-risk, hormone receptor (HR) positive, HER2-negative breast cancer (BC): SWOG/NRG/Alliance S1207 (NCT01674140). The Breast 2019, 44: s139. DOI: 10.1016/s0960-9776(19)30460-6.Peer-Reviewed Original Research