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

Not Applicable

Completed

• Conditions: Atrophic Vaginitis; Breast Cancer
• Interventions: Drug: Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklist

• Registration Number: NCT00984399
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-22
• Study First Submitted: 2009-09-24
• Study First Submitted QC: 2009-09-24
• Study First Posted: 2009-09-25
• Status Verified: 2024-05
• Primary Completion: 2024-05-13
• Study Completion: 2024-05-13
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vaginal 17β-estradiol, questionnaire , symptom checklist	Vagifem® (vaginal 17β-estradiol) questionnaire & menopause 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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
To describe patterns of estradiol and FSH levels over the twenty-four week study period.	24 weeks
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

Trial Locations

Locations (4)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Cancer Center@Phelps Memorial Hospital; 🇺🇸 Sleepy Hollow, New York, United States

Memorial Sloan Kettering Cancer Center @ Suffolk; 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering at Mercy Medical Center; 🇺🇸 Rockville Centre, New York, United States