Vaginal Estrogen for Breast Cancer

Palo Alto (17 mi)

Overseen byShari Goldfarb, MD

Age: 18+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing if Vagifem, an estrogen tablet inserted into the vagina to relieve dryness, is safe for women who have had breast cancer. These women are usually told not to use estrogen because it might cause cancer to return. The study will check if the estrogen from Vagifem stays in the vagina or enters the bloodstream and if it has any bad effects. Vagifem is commonly used to treat vaginal dryness in postmenopausal women, aiming to avoid exposure to estrogens and its associated risks.

Eligibility Criteria

This trial is for postmenopausal women with a history of stages I-III breast cancer, currently on aromatase inhibitors and experiencing vaginal dryness or related symptoms. They must be at least 18, speak English, have had a gynecology exam within six months, completed primary treatment except endocrine therapy, and show no signs of active disease.

Inclusion Criteria

I had breast cancer stages I-III confirmed by MSKCC.

I have been taking aromatase inhibitors for at least three months.

I experience symptoms like vaginal dryness, irritation, or urinary issues.

I am 18 years old or older.

I am a woman who has finished all primary cancer treatments except hormone therapy and currently show no signs of the disease.

Exclusion Criteria

I am unable to understand and agree to the study's details.

Treatment Details

The study tests if Vagifem® (vaginal estrogen) is safe for women who've had breast cancer. It examines whether the estrogen from Vagifem®, meant to alleviate vaginal dryness, gets absorbed into the bloodstream and affects breast cancer outcomes.

1Treatment groups

Experimental Treatment

Group I: vaginal 17β-estradiol, questionnaire , symptom checklistExperimental Treatment1 Intervention

This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.