A Phase II Study of Vaginal Testosterone Cream vs. the ESTRING for Vaginal Dryness or Decreased Libido in Early Breast Cancer Patients Treated With Aromatase Inhibitors

Inclusion Criteria:

1. Histologically or cytologically confirmed Stage I-III breast cancer who are taking an
aromatase inhibitor as adjuvant hormonal therapy. Patient must have started the
aromatase inhibitor at least 60 days prior to enrolling.

2. Postmenopausal estradiol levels at baseline as measured by standard laboratory
analysis.

- Patient may be rendered postmenopausal through the use of a GnRH agonist, but
must have confirmed post-menopausal levels of serum estradiol on two lab tests
at least one month apart.

- If patient has been rendered post-menopausal by adjuvant chemotherapy but has
had a period within the past 12 months, post-menopausal levels of serum
estradiol must be documented on two lab tests at least 3 months apart.

3. Age ≥18 and ≤80 years old.

4. ECOG ≤1

5. Adequate hematologic, hepatic, and renal function as defined by:

- Hgb ≥9 g/dL

- Absolute neutrophil count (ANC)/absolute granulocyte count (AGC) ≥1500 cells/mm3

- Platelet count ≥100,000/mm3

- Serum creatinine ≤1.5 mg/dL

- Total bilirubin ≤1.5 times the ULN; and aspartate aminotransferase ≤3 times the
ULN

6. Normal thyroid function tested within the past 6 months (Patients with a diagnosis of
hypothyroidism and on thyroid supplementation must have had thyroid function tests in
the normal range within the past 3 months)

7. Patient must have recovered from the side effects of previous chemotherapy, surgery,
or radiation therapy for early breast cancer.

Exclusion Criteria:

1. History of radiation to the vaginal area

2. Concurrent treatment with any type of oral, injectable or topical form of estrogen or
androgen therapy including natural supplements marketed as hormone replacement
products

3. Initiation of topical moisturizers (for example, Replens), or herbal or alternative
medicines to manage the symptoms of vaginal dryness while on study. Patients who were
previously using these products may continue them with the same usage pattern while
on study.

4. Use of vaginal hormonal products (rings, inserts, creams, gels) containing estrogens
or androgens within the past 30 days.

5. History of an abnormal pap smear within the last 12 months

6. History of endometrial or ovarian cancer

7. Any episode of vaginal bleeding in the past 6 months that has not been evaluated by a
gynecological exam and/or pelvic ultrasound

8. History of sexual dysfunction prior to diagnosis of breast cancer ( Sexual
dysfunction will be defined as loss of libido or inability to achieve orgasm for
which patient sought medical attention or which patient felt significantly interfered
with quality of life.)

9. Moderate or severe depression for which the patient is receiving ongoing
psychological counseling and/or taking antidepressants, and for whom, in the
investigators opinion may be interfering in the patients sexual function independent
of the side effects of breast cancer and aromatase inhibitor use.

10. Use of any investigational agent for breast cancer within 3 weeks of study entry.