biostudies-literatureShulman LNNCI NIH HHS2311-7https://www.ebi.ac.uk/biostudies/studies/S-EPMC4105484biostudies-literatureUnknown32(22)<h4>Purpose</h4>Optimal adjuvant chemotherapy for early-stage breast cancer balances efficacy and toxicity. We sought to determine whether single-agent paclitaxel (T) was inferior to doxorubicin and cyclophosphamide (AC), when each was administered for four or six cycles of therapy, and whether it offered less toxicity.<h4>Patients and methods</h4>Patients with operable breast cancer with 0 to 3 positive nodes were enrolled onto the study to address the noninferiority of single-agent T to AC, defined as the one-sided 95% upper-bound CI (UCB) of hazard ratio (HR) of T versus AC less than 1.30 for the primary end point of relapse-free survival (RFS). As a 2 × 2 factorial design, duration of therapy was also addressed and was previously reported.<h4>Results</h4>With 3,871 patients enrolled onJournal of clinical oncology : official journal of the American Society of Clinical OncologyComparison of doxorubicin and cyclophosphamide versus single-agent paclitaxel as adjuvant therapy for breast cancer in women with 0 to 3 positive axillary nodes: CALGB 40101 (Alliance).PMC4105484N01 CA032102U10 CA045418U10 CA047559U10 CA032102U10 CA077651U10 CA025224U10 CA077658U10 CA047577CA77658CA77651CA21115U10 CA180838U10 CA032291U10 CA021115CA33601CA31946U10 CA031946U10 CA180882P30 CA016672UG1 CA233180U10 CA180820P30 CA015083CA25224CA47577U10 CA180867CA3360U10 CA033601U10 CA180821CA47559U10 CA180888CA45418CA32291Norton LShulman LNSchneider CJO'Regan RPerez EAShapiro CLBerry DABecker HPWiner EPCirrincione CTHudis CABurstein HJMuss HMartino SKimmick GfalseComparison of doxorubicin and cyclophosphamide versus single-agent paclitaxel as adjuvant therapy for breast cancer in women with 0 to 3 positive axillary nodes: CALGB 40101 (Alliance).<h4>Purpose</h4>Optimal adjuvant chemotherapy for early-stage breast cancer balances efficacy and toxicity. We sought to determine whether single-agent paclitaxel (T) was inferior to doxorubicin and cyclophosphamide (AC), when each was administered for four or six cycles of therapy, and whether it offered less toxicity.<h4>Patients and methods</h4>Patients with operable breast cancer with 0 to 3 positive nodes were enrolled onto the study to address the noninferiority of single-agent T to AC, defined as the one-sided 95% upper-bound CI (UCB) of hazard ratio (HR) of T versus AC less than 1.30 for the primary end point of relapse-free survival (RFS). As a 2 × 2 factorial design, duration of therapy was also addressed and was previously reported.<h4>Results</h4>With 3,871 patients enrolled on2014-01-01T00:00:00Z2014 Aug2026-04-29T08:59:00.638Z2019-03-27T01:32:29ZS-EPMC41054842493478710.1200/JCO.2013.53.714210.1200/jco.2013.53.7142