biostudies-literatureColleoni MNCI NIH HHS3400-8https://www.ebi.ac.uk/biostudies/studies/S-EPMC5035120biostudies-literatureUnknown34(28)<h4>Purpose</h4>To evaluate the benefit of low-dose cyclophosphamide and methotrexate (CM) maintenance, which previously demonstrated antitumor activity and few adverse effects in advanced breast cancer, in early breast cancer.<h4>Patients and methods</h4>International Breast Cancer Study Group (IBCSG) Trial 22-00, a randomized phase III clinical trial, enrolled 1,086 women (1,081 intent-to-treat) from November 2000 to December 2012. Women with estrogen receptor- and progesterone receptor-negative (< 10% positive cells by immunohistochemistry) early breast cancer any nodal and human epidermal growth factor receptor 2 status, were randomly assigned anytime between primary surgery and 56 days after the first day of last course of adjuvant chemotherapy to CM maintenance (cyclophosphamide 50 mJournal of clinical oncology : official journal of the American Society of Clinical OncologyLow-Dose Oral Cyclophosphamide and Methotrexate Maintenance for Hormone Receptor-Negative Early Breast Cancer: International Breast Cancer Study Group Trial 22-00.PMC5035120U24 CA075362Gelber RDViale GGomez HLChirgwin JPrice KNEniu ARauch DKralidis ELang IPuglisi FThurlimann BGoldhirsch ALinderholm BKTondini CColleoni MGray KPAbdi EACoates ASGelber SRegan MMGianni LCagossi KfalseLow-Dose Oral Cyclophosphamide and Methotrexate Maintenance for Hormone Receptor-Negative Early Breast Cancer: International Breast Cancer Study Group Trial 22-00.<h4>Purpose</h4>To evaluate the benefit of low-dose cyclophosphamide and methotrexate (CM) maintenance, which previously demonstrated antitumor activity and few adverse effects in advanced breast cancer, in early breast cancer.<h4>Patients and methods</h4>International Breast Cancer Study Group (IBCSG) Trial 22-00, a randomized phase III clinical trial, enrolled 1,086 women (1,081 intent-to-treat) from November 2000 to December 2012. Women with estrogen receptor- and progesterone receptor-negative (< 10% positive cells by immunohistochemistry) early breast cancer any nodal and human epidermal growth factor receptor 2 status, were randomly assigned anytime between primary surgery and 56 days after the first day of last course of adjuvant chemotherapy to CM maintenance (cyclophosphamide 50 m2016-01-01T00:00:00Z2016 Oct2026-05-01T20:43:22.128Z2019-03-27T02:25:01ZS-EPMC50351202732586210.1200/JCO.2015.65.659510.1200/jco.2015.65.6595