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)

  • Biological Material / Translational Research

  • Substudies Info

    Co-SOFT Substudy

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

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    SOFT-EST Substudy

    This 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). The substudy is open for selected centers.

  • Results & Publications

    Publications

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

    Statistician
    Dr. Meredith Regan

    Trial Coordinator
    Meredith Kissel, Dorene Polizzi

    Data Managers
    Monica Greco, Adriana Mora de Karausch

    IBCSG Data Management Center/Frontier Science Foundation
    4033 Maple Road
    Amherst, New York 14226 USA
    Phone: +1 716 834 0900
    Fax: +1 716 833 3990
    Email:  This email address is being protected from spambots. You need JavaScript enabled to view it.


    Date of Activation
    August 4, 2003

    Date of Closure
    January 31, 2011

    Targeted Accrual
    3000 patients

    Final Accrual
    3066 patients

     

    Global completion dates 
    November 6, 2024

ETOP IBCSG Partners Foundation
Effingerstrasse 33
3008 Bern, Switzerland

Contact
Phone: +41 31 511 94 00
E-mail: contact@etop.ibcsg.org

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