Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer, Vaginitis |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/14/2018 |
| Start Date: | September 2009 |
| End Date: | September 2019 |
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.
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.
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
We found this trial at
5
sites
1000 N Village Ave
Rockville Centre, New York 11570
Rockville Centre, New York 11570
(516) 256-3600
Memorial Sloan-Kettering at Mercy Medical Center Memorial Sloan Kettering Cancer Center Rockville Centre provides state-of-the-art...
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