RATIONALE: Gathering information about the frequency and intensity of hot flashes in
patients with breast cancer and in patients who have a high risk of developing breast cancer
may help doctors learn more about menopausal symptoms.
PURPOSE: This clinical trial is looking at menopausal symptoms in women with breast cancer
or at high risk of breast cancer who received treatment on another clinical trial.
- Retrieve data from an archived database of a closed clinical trial that involved
treatment with sertraline hydrochloride or a placebo for the management of hot flashes
or other menopausal symptoms in women with breast cancer or at high risk of breast
- Analyze the results of this closed clinical trial so that they can be published.
OUTLINE: Data from an archived database of a closed clinical trial is retrieved. Descriptive
analyses of outcome variables (e.g., menopausal symptoms, including number and intensity of
hot flashes, and psychosocial and quality of life scales) are conducted to gain insight into
their distributional aspects. Data is analyzed using ANOVA with repeated measures to account
for the changes within a patient over time as a function of treatment assignment. Summary
scores from the psychosocial scales that are reasonably complete (i.e., FACT-B and POMS) are
examined using mixed linear models to account for patient-specific differences, treatment
effects, and variable patterns of completeness.
- Personal or family history of carcinoma in situ of the breast or invasive breast
- Treated with sertraline hydrochloride or a placebo on a clinical trial (that is now
closed) at the Baylor College of Medicine-The Methodist Hospital Breast Cancer Center
- Reported hot flashes with a hot flash rating of > 15 (frequency and severity) for 1
week (before starting treatment with sertraline hydrochloride or a placebo)
- No progressive metastatic breast cancer
- Hormone receptor status not specified
- Menopausal status not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Lois C. Friedman, PhD
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center