Fluocinonide Cream in Treating Symptoms of Vaginal Dryness and Painful Sexual Intercourse In Patients With Breast Cancer Undergoing Hormone Therapy

PRIMARY OBJECTIVES:

I. To estimate the decrease in symptoms of vaginal dryness and dyspareunia with the use of
fluocinonide 0.05% cream in breast cancer subjects and subjects at increased risk for breast
cancer on endocrine therapy. Estimates of decrease will be obtained utilizing patient survey
instruments.

SECONDARY OBJECTIVES:

I. To estimate the decrease in symptoms of vaginal itching and the total vaginal index score
with the use of fluocinonide 0.05% cream in breast cancer subjects and subjects at increased
risk for breast cancer on endocrine therapy. Estimates of decrease will be obtained utilizing
patient survey instruments.

II. To explore toxicities reported by subjects using fluocinonide 0.05% cream via vaginal
application.

III. To explore correlation between subject reported compliance, as well as compliance via
measurement of the amount of fluocinonide 0.05% cream used, and response rates with the use
of fluocinonide 0.05% cream.

IV. To explore the correlations between patient characteristics and response rates with the
use of fluocinonide 0.05% cream.

OUTLINE:

Patients apply topical fluocinonide cream twice daily (BID) in weeks 1-2 and once daily (QD)
in weeks 3-4.

Inclusion Criteria:

- Adult women (both pre-menopausal and post-menopausal women are eligible) and with a
history of breast cancer or with an increased risk for breast cancer on current
treatment with tamoxifen or an aromatase inhibitor with the presence of vaginal
dryness or dyspareunia of sufficient severity to make the subject patient desire
therapeutic intervention

- Vaginal dryness or dyspareunia must be present for at least two months prior to study
entry

- Subjects must be on current treatment with tamoxifen or an aromatase inhibitor for at
least two months prior to study enrollment (defined as the date of consent) and should
not be planning to discontinue treatment or to change dose or type of endocrine
treatment during the duration of the study

- Subjects must agree to not use any over-the-counter or prescription vaginal
preparations (lubricants, creams, gels, ointments, solutions) during the four weeks of
treatment with topical fluocinonide cream

- Subjects must agree to not use any medications, products, or preparations known to
contain estrogen during the four weeks of treatment with topical fluocinonide cream

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2

- Subjects must have ability to read, comprehend, and complete patient questionnaires
independently or with assistance

- Subjects must sign informed consent

- Subjects must agree to read patient instructions regarding use of barrier
contraceptive devices while on treatment with fluocinonide cream in the informed
consent

Exclusion Criteria:

- Use of any vaginal preparations within one week prior to study enrollment (exception:
subjects currently using a vaginal preparation can enroll after discontinuing
treatment for 7 days)

- Use of any estrogen containing medications, products, or preparations

- Use of any systemic oral or parenteral steroid containing medications is not
permitted; use of "High Daily Dose" inhaled/intranasal corticosteroids is not
permitted; use inhaled/intranasal corticosteroid preparations at dosing levels less
than "High Daily Dose" is permitted

- Current or past treatment with fluocinonide cream for vaginal dryness, itching, or
dyspareunia

- Subject reported symptoms of vaginal infection with significant vaginal discharge or
odor

- Known current vaginal infection

- Known vaginal pathology other than vaginal atrophy that could explain vaginal symptoms

- Known intolerance of topical steroid preparations

- Pregnant or lactating women (to be obtained via subject report only)

- Known diagnoses of diabetes mellitus, adrenal insufficiency (Addison's disease), or
Cushing's syndrome

- No prior chemotherapeutic treatment for any malignancy other than breast cancer