IBCSG 67-22 / PREcoopERA

  • A Window-of-Opportunity trial of giredestrant +/- triptorelin vs. anastrozole + triptorelin in premenopausal patients with ER-positive/HER2-negative early breast cancer.

     
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A Window-of-Opportunity trial of giredestrant +/- triptorelin vs. anastrozole + triptorelin in premenopausal patients with ER-positive/HER2-negative early breast cancer.
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A Window-of-Opportunity trial of giredestrant +/- triptorelin vs. anastrozole + triptorelin in premenopausal patients with ER-positive/HER2-negative early breast cancer.
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  • Instructional video on how to take a core needle biopsy of a breast tumor specimen
    Dr. Peter Dubsky, surgeon at the Breast Center of the Hirslanden Klinik St. Anna in Lucerne and co-chair of the PREcoopERA study, demonstrates in this instructional video how to take a core needle biopsy (CNB) of the post-treatment breast cancer specimen.
    As PREcoopERA is a window-of-opportunity study with a translational primary endpoint, which is the change in Ki-67 expression in a pre-treatment versus post-treatment biopsy, the availability of these tumor biopsies is critical.
    We hope that this instructional video will provide useful guidance on how to obtain this important post-treatment sample.
"
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Protocol<\/h2>\r\n
IBCSG 67-22 PREcoopERA Protocol v1.1<\/a> (November 1, 2023)<\/p>\r\n
PREcoopERA Protocol v1.1 PI Signature Page <\/a>(November 1, 2023)<\/p>\r\n
IBCSG PREcoopERA Protocol APPENDIX 1 v1.1<\/a> (November 1, 2023)<\/p>\r\n
IBCSG 67-22 PREcoopERA Protocol v1.0<\/a> (April 4, 2023)<\/p>\r\n
PREcoopERA Protocol v1.0 PI Signature Page<\/a> (April 4, 2023)<\/p>\r\n
Protocol_synopsis_ENG_2022-503013-32 v.1.0<\/a> (April 4, 2023)<\/p>\r\n
IBCSG PREcoopERA Protocol APPENDIX 1 <\/a>v1.0 (April 4, 2023)<\/p>\r\n
 <\/p>\r\n
Appendices <\/h2>","field53":"72"},"row1":{"field51":"Current Status","field52":"
- Current Accrual<\/strong><\/p>\r\n

  • Instructional video on how to take a core needle biopsy of a breast tumor specimen

    Dr. Peter Dubsky, surgeon at the Breast Center of the Hirslanden Klinik St. Anna in Lucerne and co-chair of the PREcoopERA study, demonstrates in this instructional video how to take a core needle biopsy (CNB) of the post-treatment breast cancer specimen.
    As PREcoopERA is a window-of-opportunity study with a translational primary endpoint, which is the change in Ki-67 expression in a pre-treatment versus post-treatment biopsy, the availability of these tumor biopsies is critical.
    We hope that this instructional video will provide useful guidance on how to obtain this important post-treatment sample.

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Study Chair
Dr. Elisabetta Munzone


Statistician
Meredith M. Regan, ScD, Dr. Ruichao Shi 


Trial Coordinator
Dorene Polizzi, Poonam Jani


Data Manager
Monica Greco, Poonam Jani


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.


Monitoring
ETOP IBCSG Partners Foundation
Coordinating Center, Bern, Switzerland
Phone: +41 31 511 94 00
Fax: +41 31 511 94 01
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.


Targeted Accrual
220


Protocol Release Date 
May 30, 2023


Trial Activation Date 
October 9, 2023


First Patient In 
January 25, 2024


Accrual Closure Date
August 15, 2025


Final Accrual
231


Global completion date
18 Sept 2025
"
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Study Chair
Dr. Elisabetta Munzone


Statistician
Meredith M. Regan, ScD, Dr. Ruichao Shi 


Trial Coordinator
Dorene Polizzi, Poonam Jani


Data Manager
Monica Greco, Poonam Jani


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: ibcsg67_precoopera@frontierscience.org


Monitoring
ETOP IBCSG Partners Foundation
Coordinating Center, Bern, Switzerland
Phone: +41 31 511 94 00
Fax: +41 31 511 94 01
Email: PREcoopERA-Monitoring@etop.ibcsg.org


Targeted Accrual
220


Protocol Release Date 
May 30, 2023


Trial Activation Date 
October 9, 2023


First Patient In 
January 25, 2024


Accrual Closure Date
August 15, 2025


Final Accrual
231


Global completion date
18 Sept 2025
"
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  • Study Chair
    Dr. Elisabetta Munzone

    Statistician
    Meredith M. Regan, ScD, Dr. Ruichao Shi 

    Trial Coordinator
    Dorene Polizzi, Poonam Jani

    Data Manager
    Monica Greco, Poonam Jani

    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.

    Monitoring
    ETOP IBCSG Partners Foundation
    Coordinating Center, Bern, Switzerland
    Phone: +41 31 511 94 00
    Fax: +41 31 511 94 01
    Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

    Targeted Accrual
    220

    Protocol Release Date 
    May 30, 2023

    Trial Activation Date 
    October 9, 2023

    First Patient In 
    January 25, 2024

    Accrual Closure Date
    August 15, 2025

    Final Accrual
    231

    Global completion date
    18 Sept 2025

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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