Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen

Study Overview
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Brief Summary
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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.

Official Title
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Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen

Conditions
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Atrophic Vaginitis, Breast Cancer

Intervention / Treatment
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* Drug: Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklist


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vaginal 17β-estradiol, questionnaire , symptom checklist<br>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. | Drug: Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklist<br>* The goal is to have 30 patients on letrozole and 30 on anastrozole who are initiated on vaginal estrogen for symptoms of urogenital atrophy. All subjects will receive 10mcg vaginal 17-β estradiol tablets. Each subject will serve as her own control. We will monitor serum estradiol and follicle stimulating hormone (FSH) levels closely from 0-24 weeks. We will measure serum estradiol and FSH levels at baseline, and subsequently at weeks 2, 7, 12, 18 and 24 after commencing therapy with 10mcg vaginal 17-β estradiol.<br>* Other names: checklist at baseline, week 12 and week 24.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the change in estradiol and follicle stimulating hormone (FSH) from baseline to twelve weeks in postmenopausal women receiving adjuvant aromatase inhibitors during treatment with low dose vaginal 10 µg 17- β estradiol. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the rise in estradiol in women on letrozole vs. anastrozole during treatment with low dose vaginal 10 µg 17- β estradiol to see if there are differences between aromatase inhibitors. |  | 2 years | 
| To describe patterns of estradiol and FSH levels over the twenty-four week study period. |  | 24 weeks | 
| To compare the patient's Female Sexual Function Index (FSFI) scores and menopause quality of life questionnaire at baseline, week 12 and week 24. |  | Week 12 and week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaginitis, Postmenopausal, 17-β estradiol, 09-110