Status:
COMPLETED
Brain Function in Premenopausal Women Receiving Tamoxifen With or Without Ovarian Function Suppression for Early-Stage Breast Cancer on Clinical Trial IBCSG 24-02
Lead Sponsor:
ETOP IBCSG Partners Foundation
Collaborating Sponsors:
National Cancer Institute (NCI)
Breast Cancer Trials, Australia and New Zealand
Conditions:
Breast Cancer
Fatigue
Eligibility:
FEMALE
Up to 120 years
Phase:
PHASE3
Brief Summary
RATIONALE: Learning about the long-term effects of adjuvant tamoxifen (T), adjuvant tamoxifen with ovarian function suppression (T+OFS), and exemestane with ovarian function suppression (E+ OFS) on br...
Detailed Description
OBJECTIVES: 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...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00659373
Start Date
December 1 2007
End Date
April 1 2016
Last Update
July 25 2016
Active Locations (15)
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1
Mercy General Hospital
Sacramento, California, United States, 95819
2
Front Range Cancer Specialists
Fort Collins, Colorado, United States, 80528
3
Norwalk Hospital
Norwalk, Connecticut, United States, 06856
4
Piedmont Hospital
Atlanta, Georgia, United States, 30309