Journal article

Predictive value and clinical utility of centrally assessed ER, PgR, and Ki-67 to select adjuvant endocrine therapy for premenopausal women with hormone receptor-positive, HER2-negative early breast cancer: TEXT and SOFT trials

Meredith M Regan, Olivia Pagani, Prudence A Francis, Gini F Fleming, Barbara A Walley, Roswitha Kammler, Patrizia Dell'Orto, Leila Russo, Janos Szoke, Franco Doimi, Laura Villani, Stefano Pizzolitto, Christian Oehlschlegel, Fausto Sessa, Vicente Peg Camara, Jose Luis Rodriguez Peralto, Gaetan MacGrogan, Marco Colleoni, Aron Goldhirsch, Karen N Price Show all

Breast Cancer Research and Treatment | SPRINGER | Published : 2015


The SOFT and TEXT randomized phase III trials investigated adjuvant endocrine therapies for premenopausal women with hormone receptor-positive (HR+) early breast cancer. We investigated the prognostic and predictive value of centrally assessed levels of estrogen receptor (ER), progesterone receptor (PgR), and Ki-67 expression in women with HER2-negative disease. Of 5707 women enrolled, 4115 with HER2-negative (HR+/HER2-) disease had ER, PgR, and Ki-67 centrally assessed by immunohistochemistry. Breast cancer-free interval (BCFI) was defined from randomization to first invasive local, regional, or distant recurrence or contralateral breast cancer. The prognostic and predictive values of ER, P..

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Awarded by US National Cancer Institute (NCI)

Awarded by Susan G. Komen for the Cure Promise Grant

Awarded by NHMRC

Awarded by US NIH

Awarded by CRUK


Funding Acknowledgements

We thank many pathologists who submitted tumor blocks and slides, and the patients, physicians, nurses and data managers who participated in the TEXT and SOFT clinical trials. We thank Stefania Andrighetto and Elvira Bianca Benini of the IBCSG Central Pathology Office and Wilbur Helfer of the IBCSG Coordinating Center. TEXT and SOFT received financial support for trial conduct from Pfizer, the International Breast Cancer Study Group, and the US National Cancer Institute. Pfizer and Ipsen provided drug supply. Support for the coordinating group, IBCSG: Frontier Science and Technology Research Foundation, Swiss Group for Clinical Cancer Research (SAKK), Cancer Research Switzerland/Oncosuisse, the Foundation for Clinical Cancer Research of Eastern Switzerland (OSKK), US National Cancer Institute (NCI) (US NIH CA75362), Susan G. Komen for the Cure Promise Grant (KG080081), Breast Cancer Research Foundation. Grant support of cooperative groups: Australia and New Zealand Breast Cancer Trials Group (NHMRC 351161 and 510788); SWOG (US NIH CA32102); Alliance/CALGB (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-CTG (US NIH CA077202 and CCSRI 015469 and 021039); ICR-CTSU on behalf of the National Cancer Research Institute (NCRI) Breast Clinical Studies Group United Kingdom (NCRI-BCSG-ICR-CTSU Partnership) was supported by CRUK, CRUKE/03/022, CRUKE/03/023, A15955, NIHR RM/ICR Biomedical Research Centre, and by NIHR Cambridge Biomedical Research Centre.