SWOG clinical trial number
CTSU/A011106
ALTernate Approaches for Clinical Stage II and III Estrogen Receptor Positive Breast Cancer NeoAdjuvant TrEatment (ALTERNATE) in Postmenopausal Women: A Phase III Study
Closed
Phase
Abbreviated Title
ALTERNATE
Status Notes
Permanently closed to accrual effective 07/15/19.
Effective May 9, 2019, A011106 was temporarily closed to accrual.
Effective Friday, November 30, 2018, A011106 was re-activated to new patient enrollment to Arm 1 (Anastrozole) only. IRB approval of Update #07 (released 11/30/2018) must be obtained prior to consenting or enrollment of any new patients.
Effective November 1, 2018 at 4:30 PM ET, A011106 will be temporarily closed to new patient registration to Arm 1, Arm 2 and Arm 3. Registration to Arm 1 will be reopened once Update #07 has been distributed.
An amendment is currently under review to revise the study documents to only allow future registrations to Arm 1 (Anastrozole), as Arm 1 has not yet met its accrual goal. A separate broadcast notice will be issued at that time to notify sites of the reactivation of Arm 1. Questions concerning this notice may be directed to the Alliance Protocol Coordinator, Ms. Laura Hoffman, at 773-834-2546 or hoffma12@uchicago.edu
Effective May 9, 2019, A011106 was temporarily closed to accrual.
Effective Friday, November 30, 2018, A011106 was re-activated to new patient enrollment to Arm 1 (Anastrozole) only. IRB approval of Update #07 (released 11/30/2018) must be obtained prior to consenting or enrollment of any new patients.
Effective November 1, 2018 at 4:30 PM ET, A011106 will be temporarily closed to new patient registration to Arm 1, Arm 2 and Arm 3. Registration to Arm 1 will be reopened once Update #07 has been distributed.
An amendment is currently under review to revise the study documents to only allow future registrations to Arm 1 (Anastrozole), as Arm 1 has not yet met its accrual goal. A separate broadcast notice will be issued at that time to notify sites of the reactivation of Arm 1. Questions concerning this notice may be directed to the Alliance Protocol Coordinator, Ms. Laura Hoffman, at 773-834-2546 or hoffma12@uchicago.edu
Activated
02/15/2014
Closed
07/15/2019
Participants
ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE
Research committees
Breast Cancer
Treatment
Paclitaxel
Anastrozole
Fulvestrant
Eligibility Criteria Expand/Collapse
SWOG is participating in this study through the Cancer Trials Support Unit (CTSU) of the National Cancer Institute.
Please contact the CTSU directly by phone (888/823-5923) or on the CTSU website (http://www.ctsu.org/) for more information and registration procedures.
Please contact the CTSU directly by phone (888/823-5923) or on the CTSU website (http://www.ctsu.org/) for more information and registration procedures.
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