Breast Cancer Clinical Trial
Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen
Summary
The purpose of this study is to see if Vagifem® 10mcg is safe for women who have had breast cancer. Vagifem is an estrogen product. It is a tiny tablet that is inserted into the vagina. It relieves vaginal dryness. Women who have had breast cancer are usually told not to take estrogen. This is because estrogen use can lead to a breast cancer recurrence or a new primary breast cancer. It is unclear if the estrogen in Vagifem is only absorbed in the vagina. It may be absorbed into the blood stream for a short time and may cause a brief rise in your estrogen level. However, there is no clear evidence that this would cause any bad effects in patients with breast cancer. How much, if any, of these topical estrogens are absorbed through the vagina is not known. We also do not know what the impact is of low dose estrogen absorption on breast cancer outcomes. Also, the absorption should decrease as the mucus membranes are restored after estrogen exposure.
Eligibility Criteria
Inclusion Criteria:
History of breast cancer, stages I-III with pathology confirmed at MSKCC
Women who have completed all of their primary treatment (surgery, radiation therapy, adjuvant chemotherapy) with the exception of endocrine therapy and currently have no clinical evidence of disease.
Women who are currently on aromatase inhibitors for at least three months--either letrozole or anastrozole
Women with symptomatic urogenital atrophy: vaginal dryness, irritation, pruritus, dyspareunia, urinary frequency and/or urinary incontinence
Menopausal at study entry defined as:
Bilateral salpingo-oophorectomy independent of age
If natural menopause, age ≥ 50 with cessation of menses for at least 12 months
If menopause induced by chemotherapy, age ≥ 50 with no menstrual period at least 12 months after chemotherapy finished
At least 18 years of age
Able to participate in the informed consent process
Gynecology examination within six months
Able to read/speak English
Exclusion Criteria:
Inability to give informed consent
Vaginal bleeding of unknown etiology within 12 months of study entry
History of prior vaginal 17-β estradiol or other topical estrogen use within the past six months
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There are 2 Locations for this study
Basking Ridge New Jersey, , United States
Commack New York, 11725, United States
New York New York, 10065, United States
Rockville Centre New York, , United States
Sleepy Hollow New York, , United States
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