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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00984399
• Other study ID #: 09-110
• Status: Completed
• Phase: N/A
• Start date: September 22, 2009
• Est. completion date: May 13, 2024

Study information

• Verified date: May 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 13, 2024
• Est. primary completion date: May 13, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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-ß estradiol or other topical estrogen use within the past six months

Related Conditions & MeSH terms

• Atrophic Vaginitis
• Breast Cancer
• Breast Neoplasms
• Vaginitis

Intervention

Drug:
• Vagifem® (vaginal 17ß-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-ß 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-ß estradiol.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Cancer Center @ Suffolk	Commack	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering at Mercy Medical Center	Rockville Centre	New York
United States	Memorial Sloan Kettering Cancer Center@Phelps Memorial Hospital	Sleepy Hollow	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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- ß estradiol.		2 years
Secondary	To compare the rise in estradiol in women on letrozole vs. anastrozole during treatment with low dose vaginal 10 µg 17- ß estradiol to see if there are differences between aromatase inhibitors.		2 years
Secondary	To describe patterns of estradiol and FSH levels over the twenty-four week study period.		24 weeks
Secondary	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

External Links

•   Memorial Sloan Kettering Cancer Center