Intervention: Fluocinonide
Trial phase: Phase 2
ATC code: C05AA11 | D07AC08 | D07CC05
SMILES: [H][C@@]12C[C@@]3([H])OC(C)(C)O[C@@]3(C(=O)COC(C)=O)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.

All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
Eligibility criteria:
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