Brain Function in Premenopausal Women Receiving Tamoxifen With or Without Ovarian Function Suppression for Early-Stage Breast Cancer on Clinical Trial IBCSG 24-02
NCT ID: NCT00659373
Last Updated: 2016-07-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
86 participants
INTERVENTIONAL
2007-12-31
2016-04-30
Brief Summary
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PURPOSE: This study is looking at brain function in premenopausal women who are receiving adjuvant tamoxifen (T) alone against those receive adjuvant tamoxifen (T+OFS) or exemestane (E+OFS) with ovarian function suppression (OFS) for early-stage breast cancer on clinical trial IBCSG-2402.
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Detailed Description
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Primary:
\* To evaluate and compare the changes in cognitive function over one year in premenopausal breast cancer patients who receive adjuvant tamoxifen (T) alone against those receive adjuvant tamoxifen (T+OFS) or exemestane (E+OFS) with ovarian function suppression (OFS).
OUTLINE: This is a multicenter study.
Objective cognitive function was measured with the CogState computerized test battery. The CogState battery consists of seven tasks: Detection, Identification, Monitoring, Memory, Learning, International Shopping List Task (ISLT), and ISLT-Delayed Recall. Performance speed is measured for the Detection, Identification and Monitoring tasks and performance accuracy is measured for the Memory, Learning, ISLT, and ISLT-Delayed Recall. Measures of performance speed are normalized using measures of performance accuracy (%) are normalized using arcsine transformation. The main outcome measure is a composite score which is the average of these task scores (after transformation and standardization by age-specific norms). Patients complete these assessments at baseline (i.e. before start of protocol hormonal therapy) and approximately one year after randomization to the parent IBCSG 24-02 (SOFT) study.
Data were collected separately for the T+OFS and E+OFS participants in the parent study, IBCSG 24-02 (SOFT). The sample size for this Co-SOFT substudy was small, so the analysis plan was revised to pre-specify collective analysis for all patients receiving OFS.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Tamoxifen
Tamoxifen 20mg orally daily for 5 years
Tamoxifen
T+OFS
Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
Tamoxifen
triptorelin
E+OFS
Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
triptorelin
Exemestane
Interventions
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Tamoxifen
triptorelin
Exemestane
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed breast cancer
* Completely resected disease
* Registered for clinical trial IBCSG-2402, but not yet started protocol hormonal therapy
* Has not yet received any of the following adjuvant endocrine therapy, either before or after registration on IBCSG-2402:
* Tamoxifen, exemestane, or gonadotropin-releasing hormone (GnRH) agonist
* Ovarian irradiation
* Bilateral oophorectomy
* Hormone receptor status:
* Estrogen and/or progesterone receptor positive
* Each tumor must be hormone receptor positive
PATIENT CHARACTERISTICS:
* Premenopausal
* Can speak and read the local language(s) fluently
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
120 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Breast Cancer Trials, Australia and New Zealand
OTHER
Cancer and Leukemia Group B
NETWORK
ETOP IBCSG Partners Foundation
NETWORK
Responsible Party
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Principal Investigators
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Juerg Bernhard, PhD
Role: STUDY_CHAIR
ETOP IBCSG Partners Foundation
Kelly-Anne Phillips
Role: STUDY_CHAIR
Peter MacCallum Cancer Centre, Australia
Timothy Ahles, MD
Role: STUDY_CHAIR
Cancer and Leukemia Group B
Locations
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Mercy General Hospital
Sacramento, California, United States
Front Range Cancer Specialists
Fort Collins, Colorado, United States
Norwalk Hospital
Norwalk, Connecticut, United States
Piedmont Hospital
Atlanta, Georgia, United States
Northside Hospital Cancer Center
Atlanta, Georgia, United States
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States
CCOP - Atlanta Regional
Atlanta, Georgia, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
Concord, New Hampshire, United States
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Manhasset, New York, United States
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States
Batte Cancer Center at Northeast Medical Center
Concord, North Carolina, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada
Countries
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References
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Phillips KA, Regan MM, Ribi K, Francis PA, Puglisi F, Bellet M, Spazzapan S, Karlsson P, Budman DR, Zaman K, Abdi EA, Domchek SM, Feng Y, Price KN, Coates AS, Gelber RD, Maruff P, Boyle F, Forbes JF, Ahles T, Fleming GF, Bernhard J. Adjuvant ovarian function suppression and cognitive function in women with breast cancer. Br J Cancer. 2016 Apr 26;114(9):956-64. doi: 10.1038/bjc.2016.71. Epub 2016 Apr 19.
Other Identifiers
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IBCSG-24-02-ANZ0701
Identifier Type: -
Identifier Source: secondary_id
ANZ0701
Identifier Type: -
Identifier Source: secondary_id
CALGB-IBCSG-24-02-ANZ0701
Identifier Type: -
Identifier Source: secondary_id
CDR0000594003
Identifier Type: -
Identifier Source: org_study_id
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