{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T08:55:42Z","timestamp":1793350542386,"version":"4.5.0"},"reference-count":37,"publisher":"Oxford University Press (OUP)","issue":"10","license":[{"start":{"date-parts":[[2021,4,2]],"date-time":"2021-04-02T00:00:00Z","timestamp":1617321600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["81672600"],"award-info":[{"award-number":["81672600"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["81722032"],"award-info":[{"award-number":["81722032"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["82072916"],"award-info":[{"award-number":["82072916"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["91959207"],"award-info":[{"award-number":["91959207"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]},{"name":"2018 Shanghai Youth Excellent Academic Leader"},{"name":"Fudan ZHUOSHI Project"},{"name":"Municipal Project for Developing Emerging and Frontier Technology in Shanghai Hospitals","award":["SHDC12010116"],"award-info":[{"award-number":["SHDC12010116"]}]},{"name":"Cooperation Project of Conquering Major Diseases in the Shanghai Municipality Health System","award":["2013ZYJB0302"],"award-info":[{"award-number":["2013ZYJB0302"]}]},{"name":"Innovation Team of the Ministry of Education","award":["IRT1223"],"award-info":[{"award-number":["IRT1223"]}]},{"name":"Shanghai Key Laboratory of Breast Cancer","award":["12DZ2260100"],"award-info":[{"award-number":["12DZ2260100"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,10,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Chemotherapy-induced premature menopause leads to some consequences, including infertility. We initiated this randomized phase III trial to determine whether a cyclophosphamide-free adjuvant chemotherapy regimen would increase the likelihood of menses resumption and improve survival outcomes.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Young women with operable estrogen receptor-positive HER2-negative breast cancer after definitive surgery were randomly assigned to receive adjuvant epirubicin and cyclophosphamidefollowed by weekly paclitaxel (EC-wP) or epirubicin and paclitaxel followed by weekly paclitaxel (EP-wP). All patients received at least 5-year adjuvant endocrine therapy after chemotherapy. Two coprimary endpoints were the rate of menstrual resumption at 12\u2009months after chemotherapy and 5-year disease-free survival in the intention-to-treat population. This study is registered at ClinicalTrials.gov (NCT01026116). All statistical tests were 2-sided.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Between January 2011 and December 2016, 521 patients (median age = 34\u2009years; interquartile range = 31-38\u2009years) were enrolled, with 261 in the EC-wP group and 260 in the EP-wP group. The rate of menstrual resumption at 12\u2009months after chemotherapy was 48.3% in EC-wP (95% confidence interval [CI] = 42.2% to 54.3%) and 63.1% in EP-wP (95% CI = 57.2% to 68.9%), with an absolute difference of 14.8% (95% CI = 6.37% to 23.2%, P\u2009&amp;lt;\u2009.001). The posthoc exploratory analysis by patient-reported outcome questionnaires indicated that pregnancy might occur in fewer women in the EC-wP group than in the EP-wP group. At a median follow-up of 62\u2009months, the 5-year disease-free survival was 78.3% (95% CI = 72.2% to 83.3%) in EC-wP and 84.7% (95% CI = 79.3% to 88.8%) in EP-wP (stratified log-rank P\u2009=\u2009.07). The safety data were consistent with the known safety profiles of relevant drugs.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The cyclophosphamide-free chemotherapy regimen might be associated with a higher probability of menses resumption.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jnci\/djab065","type":"journal-article","created":{"date-parts":[[2021,4,1]],"date-time":"2021-04-01T19:18:49Z","timestamp":1617304729000},"page":"1352-1359","source":"Crossref","is-referenced-by-count":15,"title":["Cyclophosphamide-Free Adjuvant Chemotherapy for Ovarian Protection in Young Women With Breast Cancer: A Randomized Phase 3 Trial"],"prefix":"10.1093","volume":"113","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2883-1282","authenticated-orcid":false,"given":"Ke-Da","family":"Yu","sequence":"first","affiliation":[{"name":"Department of Breast Surgery, Fudan University 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