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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-22

Study Completion Date

2024-05-13

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.

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Detailed Description

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Conditions

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Atrophic Vaginitis Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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vaginal 17β-estradiol, questionnaire , symptom checklist

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.

Group Type EXPERIMENTAL

Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklist

Intervention Type DRUG

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.

Interventions

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Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklist

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.

Intervention Type DRUG

Other Intervention Names

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The bloodwork will take less than one hour to perform and will be drawn +/- 72hrs from the date the patient is due for bloodwork.Baseline bloodwork will be drawn within 14 days of study enrollment prior to the initiation of vaginal 25μg 17- β estradiol. Patients will be encouraged to come for their research bloodwork 12-24 hours after the insertion of the vaginal 25μg 17- β estradiol tablets. Patients will record in their diary the time of their last vaginal 10μg 17- β estradiol tablet insertion. Since we do not know the clinical significance of transient estradiol elevation in these patients, both the patients and the investigators will be blinded to the results of these assays for the 24 weeks of study therapy. We will administer the FSFI survey questionnaire and menopause symptom checklist at baseline, week 12 and week 24.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No