Estrogen Levels Among Breast Cancer Patients
Conditions
Brief summary
Estrogen receptor positive breast cancer is the most common type of breast cancer and anti-estrogen therapy has been shown to be very effective in preventing recurrence. Side effects of anti-estrogens are due to estrogen deprivation and include hot flashes, mood changes and vaginal dryness/pain. Vaginal symptoms including pain, dryness, itching, bleeding after intercourse and frequent urinary tract infections have been reported to cause significant morbidity in postmenopausal women and higher in breast cancer survivors on anti-estrogen therapy. Treatment options include vaginal lubricants, Replens etc but unfortunately many women continue to have persistent symptoms. Local estrogen has been shown to be effective in post menopausal women (Estring or Vagifem) for their vaginal symptoms. There is a concern of using this in women with breast cancer given it may increase their blood estrogen levels. Studies done so far show have shown controversial results but majority of them report that blood estrogen levels do not change significantly. The major drawback of the studies was the sample size and inadequate accrual. The most recent trial reported showed no significant change in blood estrogen levels in women with breast cancer treated with aromatase inhibitors (anti-estrogen therapy) and were on vagifem for their vaginal symptoms. The authors reported results in 26 patients and reported no significant change in blood estrogen level. We propose to study the change in blood estrogen level when postmenopausal women with breast cancer who are currently on aromatase inhibitors are treated with Estring for their vaginal symptoms.
Interventions
DRUGEstradiol
Sponsors
University of Arizona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Stage I-III estrogen receptor positive breast cancer (positive for estrogen receptor (ER)) with positivity defined as immunohistochemical staining in ≥ 10% of cells) on adjuvant hormonal therapy with aromatase inhibitors (anastrozole, letrozole or exemestane) * Adults over 18 years of age with a life expectancy of at least 3 months * Attained menopause as defined by World Health Organization Criteria (defined as permanent cessation of menstruation resulting from the loss of ovarian follicular activity. This is recognized to occur after 12 consecutive months of amenorrhea, for which there is no other obvious pathological or physiological cause.) * Persistent genitourinary symptoms causing discomfort for more than 2 weeks prior to the visit with the physician. * Tried at least 1 prior pharmacological/ non-pharmacological treatment for their genitourinary symptoms * Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to any study specific procedures * Be willing and able to comply with the treatment plan, scheduled clinic visits, laboratory tests and other study procedures
Exclusion criteria
* Patients with metastatic breast cancer * Have a concurrent active non-breast malignancy except for non-melanoma skin cancer * Patients with vaginal stenosis * Patients unable to apply Estring
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Serum Estradiol | Baseline, 16 weeks | To measure changes in serum estradiol level compared to their baseline in patients with breast cancer when treated with vaginal estrogen preparation, Estring |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Estradiol ESTRING® (estradiol vaginal ring) is a slightly opaque ring with a whitish core containing a drug reservoir of 2 mg estradiol. Estradiol, silicone polymers and barium sulfate are combined to form the ring. When placed in the vagina, ESTRING releases estradiol, approximately 7.5 mcg per 24 hours, in a consistent stable manner over 90 days. | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Estradiol |
|---|---|
| Age, Continuous | 55 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Changes in Serum Estradiol
To measure changes in serum estradiol level compared to their baseline in patients with breast cancer when treated with vaginal estrogen preparation, Estring
Time frame: Baseline, 16 weeks
Population: Eligible patients were 18 years or older, diagnosed with HR-positive breast cancer defined as \> 1% of tumor cells expressing estrogen or progesterone receptors, attained menopause as defined by the World Health Organization, and on adjuvant hormonal therapy with an aromatase inhibitor- anastrozole, letrozole, or exemestane. Patients with metastatic disease were excluded.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Estring Group | Changes in Serum Estradiol | 3.9 pg/mL |