Journal article

Adjuvant Exemestane With Ovarian Suppression in Premenopausal Breast Cancer: Long-Term Follow-Up of the Combined TEXT and SOFT Trials

O Pagani, BA Walley, GF Fleming, M Colleoni, I Láng, HL Gomez, C Tondini, HJ Burstein, MP Goetz, EM Ciruelos, V Stearns, HR Bonnefoi, S Martino, CE Geyer, C Chini, F Puglisi, S Spazzapan, T Ruhstaller, EP Winer, B Ruepp Show all

Journal of Clinical Oncology | LIPPINCOTT WILLIAMS & WILKINS | Published : 2023

Abstract

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.The combined analysis of SOFT-TEXT compared outcomes in 4,690 premenopausal women with estrogen/progesterone receptor-positive (ER/PgR+) early breast cancer randomly assigned to 5 years of exemestane + ovarian function suppression (OFS) versus tamoxifen + OFS. After a median fo..

View full abstract

University of Melbourne Researchers

Grants

Awarded by National Institutes of Health


Funding Acknowledgements

SOFT and TEXT are sponsored by ETOP IBCSG Partners Foundation. Conduct is supported by the ETOP IBCSG Partners Foundation, whichhas included additional support for the IBCSG from the Frontier Science Foundation, Swiss Group for Clinical Cancer Research Switzerland, Oncosuisse, Cancer League Switzerland, Foundation for Clinical Cancer Research of Eastern Switzerland, grant U24 CA075362 from the US NCI. Longer-term follow-up of SOFT and TEXT has been supported also bygrants to the IBCSG from Pfizer (WI223438), Ipsen, Debiopharm, TerSera, AstraZeneca (57735423), the Breast Cancer Research Foundation (16-185, 17-187, 18-003, 19-011, 20-011, 21-011) and private donors. SOFT and TEXT conduct in the US and Canada have been supported by US NCI NCTN via the Alliance for Clinical Trials in Oncology (grant Nos. above). Supported by Breast Cancer Trials Australia and New Zealand (National Health and Medical Research Council grant Nos.351161, 510788 and 1105058); Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU) on behalf of the National Cancer Research Institute Breast Clinical Studies Group United Kingdom (NCRI-BCSG-ICR-CTSU Partnership), Cancer Research UK grant Nos.CRUKE/03/022, CRUKE/03/023, C1491/A15955; National Institute for Health Research Royal Marsden/Institute of Cancer Research Biomedical Research Centre (no grant No.); and National Institute for Health Research/Cambridge Biomedical Research Centre (no grant No.);Alliance for Clinical Trials in Oncology (US NIH grant No.U10CA180821); SWOG (US National Institutes of Health [NIH] grant Nos. U10CA180888, UG1CA233160, UG1CA233329); ECOG-ACRIN Cancer Research Group (US NIH grant Nos. U10CA180820, U10CA180794); NRG Oncology (US NIH grant Nos. U10CA180868, U10CA180822, UG1CA189867); Canadian Cancer Trials Group (USNIH grant No. U10CA180863, and Canadian Cancer Society grant No.707213).