Breast Cancer Clinical Trial
Official title:
Investigating Cognitive Function for Patients Participating in the BIG Trial 1-98 in Select Centers
RATIONALE: Studying cognitive function, such as thinking, attention, concentration, and
memory, in postmenopausal women receiving hormone therapy for breast cancer may help improve
quality of life and the ability to plan treatment for cancer.
PURPOSE: This phase III trial is studying cognitive function in postmenopausal women with
breast cancer receiving hormone therapy on clinical trial IBCSG-1-98.
OBJECTIVES:
Primary
- Compare cognitive function in postmenopausal women with breast cancer who have received
5 years of adjuvant tamoxifen vs letrozole on protocol IBCSG-1-98.
Secondary
- Compare cognitive function in patients who have received a single hormonal therapy for
5 years vs those who have received that same hormonal therapy for 3 years, having
previously received an alternate hormonal therapy for 2 years.
- Compare improvement in cognitive function 1 year after cessation of adjuvant hormonal
therapy.
- Compare changes in cognitive function in patients who have received prior adjuvant
chemotherapy vs those who have not received adjuvant chemotherapy.
- Assess the relationship between objective and subjective measures of cognitive
function, including specific cognitive domains.
- Assess the relationship between cognitive function and psychological distress, fatigue,
and quality of life.
OUTLINE: This is a longitudinal, multicenter study.
Patients undergo cognitive function testing and complete self-reported questionnaires
regarding cognitive ability, quality of life, fatigue, and psychosocial status during the
fifth year of adjuvant hormonal therapy on protocol IBCSG-1-98 and then during the sixth
year* (post randomization on protocol IBCSG-1-98) (i.e., after completion of adjuvant
hormonal therapy).
NOTE: *Patients who receive extended letrozole, hormone replacement therapy, or other
endocrine therapy beyond 5 years do not undergo the 6-year assessment.
PROJECTED ACCRUAL: A total of 148 patients will be accrued for this study.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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