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IBCSG 24-02 / BIG 2-02 (SOFT) 

A phase III trial evaluating the role of ovarian function suppression and the role of exemestane as adjuvant therapies for premenopausal women with endocrine responsive breast cancer

Suppression of Ovarian Function Trial (SOFT)


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Co-SOFT Substudy

The Cognitive Function Substudy is investigating cognitive function for patients participating in the SOFT trial in selected centers.

SOFT-EST Substudy

The SOFT-EST Substudy investigates estrogen levels at different timepoints during the first 4 years of protocol treatment among patients receiving triptorelin plus either tamoxifen (arm B) or exemestane (arm C).

Results & Publications


Study Chairs
BIG: Dr. Prue Francis - Melbourne, Australia
US Intergroup: Dr. Gini Fleming - Chicago, USA

Dr. Meredith Regan, Dr. Weixiu Luo, Dr. P. Kathryn Gray

Lead Trial Coordinator
Holly Shaw

Data Managers
Karolyn Scott, Monica Greco, Adriana Mora de Karausch, Patricia Gonzalez

IBCSG Data Management Center/FSTRF
4033 Maple Road
Amherst, New York 14226 USA
Phone: +1 716 834 0900
Fax: +1 716 833 3990
Email: ibcsg24-26_STP@fstrf.org

Date of Activation
August 4, 2003

Date of Closure
January 31, 2011

Targeted Accrual
3000 patients

Final Accrual
3066 patients

Substudies Co-SOFT Substudy
Results Publications Results & Publications
Other Pathology


Clinical Trials

New publications are available 

BIG Time for Baby - the Storks spread their wings

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