Trial Information

The Effect of Chemotherapy on Aging in Older Women With Breast Cancer as Measured by Expression of p16INK4a

OBJECTIVES:

Primary

- To measure and compare normalized p16^INK4a gene expression in women ≥ 65 years of age
with stage I-III breast cancer who have completed primary therapy comprising surgery
with or without radiotherapy followed by endocrine therapy (cohort 2) versus surgery
with or without radiotherapy followed by chemotherapy and with or without endocrine
therapy (cohort 3) .

- To measure and compare normalized p16^INK4a gene expression in women ≥ 65 years of age
with stage I-III breast cancer who have completed primary therapy comprising surgery
with or without radiotherapy (cohort 1) versus women treated in cohort 2.

- To compare normalized p16^INK4a gene expression between cohorts 1, 2, and 3 versus an
age-matched contemporaneous control group of healthy volunteers accrued from a separate
study (cohort 4).

Secondary

- To access functional status (ability to live independently at home and in the
community), co-morbid medical conditions, cognition, psychological status, social
functioning and support, medication review, nutritional status, and health-behavior
status of these patients.

Tertiary (exploratory)

- To compare methodologies of p16 ^INK4a gene expression measurement in 50 patients in
order to develop a batchable and analytically validated assay that eliminates the need
for rapid sample processing.

- To explore any association between p16^INK4a expression and amount of vigorous physical
activity, smoking habits, and/or weekly alcohol consumption.

- To explore any association between p16^INK4a expression and type of chemotherapy
received, co-morbidities, concomitant medications, and/or tumor characteristics.

- To correlate p16^INK4a expression with scores from selected domains of the Geriatric
Assessment (i.e., cognitive function, activities of daily living (ADL), and the
instrumental ADL.

OUTLINE: Breast cancer survivors and healthy volunteers undergo blood collection for
p16^INK4a gene expression analysis by Taqman RT-PCR.

Breast cancer survivors complete the Health Behavior and the Geriatric Assessment
Questionnaires. They also complete a Timed Up and Go test to determine physical mobility.

Medical charts are reviewed to record information about diagnosis and treatment.