A Prospective Trial to Assess Breast Cancer Survivors and Vaginal Atrophy Treatment Outcomes

Breast cancers that are hormone sensitive require estrogen suppression as a part of
multimodal treatment. Estrogen suppression also reduces the likelihood of a breast cancer
recurrence. Therefore, breast cancer survivors with estrogen sensitive tumors are placed on
hormone suppression therapy with either selective estrogen receptor modulators like tamoxifen
or aromatase inhibitors like anastrazole. This therapy typically is administered for five
years after a cancer diagnosis. Regardless of age or pre-existing menopausal status, the
hormone suppression reduces estrogen levels and can either exacerbate existing menopausal
symptoms or induce medical menopause in otherwise premenopausal women. This study will
evaluate the patient's perspective of vaginal therapy using the Viveve® device in breast
cancer patients.

Key Inclusion Criteria:

- 18 years or older

- Breast cancer survivors defined as women with a history of hormone sensitive breast
cancer on tamoxifen

- Self-reported vaginal laxity

- Meet diagnosis of sexual dysfunction

- Patients must be able to understand and willing to sign a written informed consent
document and be willing to complete the patient reported outcome tools at the
scheduled time points

Exclusion Criteria:

- Cognitive impairment

- Women currently on chemotherapy and/or radiation or who have had their last
chemotherapy within 6 months of the intervention

- Women with active breast cancer disease

- Women currently on hormone therapy or who are pregnant

- Women who have had vaginal or pelvic surgery involving the genitalia