Trial Information

Investigating Cognitive Function for Patients Participating in the BIG Trial 1-98 in Select Centers

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.