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

Condition(s) targeted: Atrophic Vaginitis; Breast Cancer

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

Phase: N/A

Status: Recruiting

Sponsored by: Memorial Sloan-Kettering Cancer Center

Official(s) and/or principal investigator(s):
Mercedes Castiel, MD, Principal Investigator, Affiliation: Memorial Sloan-Kettering Cancer Center

Overall contact:
Mercedes Castiel, MD, Phone: 212-639-5060

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

Study design: Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome:

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.

To describe patterns of estradiol and FSH levels over the twenty-four week study period.

To compare the patient's Female Sexual Function Index (FSFI) scores and menopause quality of life questionnaire at baseline, week 12 and week 24.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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

Mercedes Castiel, MD, Phone: 212-639-5060

Memoral Sloan Kettering Cancer Center, Basking Ridge, New Jersey, United States; Recruiting
Mercedes Castiel, MD

Memorial Sloan-Kettering Cancer Center @ Suffolk, Commack, New York 11725, United States; Recruiting
Mercedes Castiel, MD

Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States; Recruiting
Mercedes Castiel, MD

Memorial Sloan-Kettering at Mercy Medical Center, Rockville Centre, New York, United States; Recruiting
Mercedes Castiel, MD

Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital, Sleepy Hollow, New York, United States; Recruiting
Mercedes Castiel, MD

Memorial Sloan-Kettering Cancer Center

Starting date: September 2009
Last updated: September 16, 2011