Trial Information

Investigating Cognitive Function for Patients Participating in the SOFT Trial in Selected Centers

OBJECTIVES:

Primary:

- To evaluate and compare changes in cognitive function over 1 year in premenopausal
breast cancer patients who receive adjuvant tamoxifen with or without ovarian function
suppression (OFS).

Secondary:

- To compare the effect of tamoxifen with OFS versus exemestane with OFS on cognitive
function over 1 year.

- To compare the effect of tamoxifen alone versus exemestane with OFS on cognitive
function over 1 year.

- To evaluate and compare changes in cognitive function over 5 years and 6 years between
the 3 treatment groups (pending funding becoming available for the year 5 and 6
measures) on clinical trial IBCSG-2402.

- To explore the impact of receiving or not receiving prior chemotherapy on changes in
cognitive function.

- To explore the relationship between subjective and objective cognitive function.

- To explore the relationship between cognitive function, psychological distress,
fatigue, insomnia, and quality of life.

OUTLINE: This is a multicenter study.

Patients undergo objective cognitive function assessment over 20-25 minutes, using the
CogState computerized test battery, which consists of five tasks that measure the speed of
psychomotor function, visual attention, working memory and the accuracy of working memory,
learning and memory and executive function (all non-verbal). They undergo subjective
cognitive function assessment, using the Cognitive Failures Questionnaire (CFQ), a 25-item
self-report measure that assesses a person's failures in memory, perception, and motor
function over the past 6 months. Patients also complete General Health Questionnaire -12
(measuring psychologic distress), Brief Fatigue Inventory, NCI Common Terminology Criteria
for Adverse Events, and a patient-rated linear analogue self-assessment (LASA) scale
measuring insomnia. Patients complete these assessments at baseline (after registration to
clinical trial IBCSG-2402, but before beginning protocol therapy) and at 1, 5, and 6 years
after randomization on IBCSG-2402.

Relevant clinical factors, such as age, adjuvant chemotherapy, co-morbidity and concomitant
medications are assessed. In addition, language, education, psychiatric and neurological
history, alcohol consumption and right/left handedness are also assessed.