Journal article

Adjuvant ovarian function suppression and cognitive function in women with breast cancer

Kelly-Anne Phillips, Meredith M Regan, Karin Ribi, Prudence A Francis, Fabio Puglisi, Meritxell Bellet, Simon Spazzapan, Per Karlsson, Daniel R Budman, Khalil Zaman, Ehtesham A Abdi, Susan M Domchek, Yang Feng, Karen N Price, Alan S Coates, Richard D Gelber, Paul Maruff, Frances Boyle, John F Forbes, Tim Ahles Show all



BACKGROUND: To examine the effect on cognitive function of adjuvant ovarian function suppression (OFS) for breast cancer. METHODS: The Suppression of Ovarian Function (SOFT) trial randomised premenopausal women with hormone receptor-positive breast cancer to 5 years adjuvant endocrine therapy with tamoxifen+OFS, exemestane+OFS or tamoxifen alone. The Co-SOFT substudy assessed objective cognitive function and patient reported outcomes at randomisation (T0), and 1 year later (T1); the primary endpoint was change in global cognitive function, measured by the composite objective cognitive function score. Data were compared for the pooled tamoxifen+OFS and exemestane+OFS groups vs the tamoxifen a..

View full abstract


Awarded by Australian National Health and Medical Research Council

Awarded by US NIH

Awarded by US National Cancer Institute (NCI)

Awarded by NHMRC

Awarded by CCSRI

Awarded by National Breast Cancer Foundation


Funding Acknowledgements

We thank the patients who participated and the staff who conducted the study at the participating centres. We also thank the ANZBCTG Trials Coordination Department staff Lauren Boyes, Ingrid Laycock, Annette Dempsey and Dianne Lindsay and the International Breast Cancer Study Group (IBCSG) Coordinating and Data Management Centres for their help with the conduct of this study. The Co-SOFT study was funded by the Australian National Health and Medical Research Council (#454507) and the Breast Cancer Institute of Australia, the Fund Raising Department of the Australia and New Zealand Breast Cancer Trials Group (ANZBCTG); US NIH SU10CA-035279-30 to DRB. KAP is an Australian National Breast Cancer Foundation Fellow. Support for the IBCSG: Frontier Science and Technology Research Foundation, Swiss Group for Clinical Cancer Research (SAKK), US National Cancer Institute (NCI) (CA75362) to MMR, Swiss Cancer Research/Oncosuisse. Grant support for participating cooperative groups for the SOFT Trial: Australia and New Zealand Breast Cancer Trials Group (NHMRC 351161 and 510788); SWOG (US NIH CA32102); Alliance (US NIH U10-CA180821); ECOG-ACRIN (US NIH CA21115 and CA16116); NSABP/NRG (US NIH U10-CA-12027, U10-CA-69651, U10-CA-37377, U10-CA-69974); NCIC (US NIH CA077202 and CCSRI 015469 and 021039). The SOFT trial receives financial support for trial conduct from Pfizer, and drug supply from Pfizer and Ipsen. P.M. is a full time employee of Cogstate, Ltd. PAF has provided unpaid consultancy and an unpaid overseas presentation regarding the results of the SOFT trial for Pfizer. The IBCSG Statistical Center (MMR, YF, RDG, KNP) has received research support from Pfizer and Ipsen in support of SOFT and TEXT.