Investigating Cognitive Function for Patients Participating in the BIG Trial 1-98 in Select Centers
- Compare cognitive function in postmenopausal women with breast cancer who have received
5 years of adjuvant tamoxifen vs letrozole on protocol IBCSG-1-98.
- 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
- 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
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
Objective cognitive function as measured by the CogState battery
6 years after randomization
Peter MacCallum Cancer Centre, Australia
United States: Federal Government