Estradiol Levels in Patients Treated With Estring
Condition: Estrogen Levels Among Breast Cancer Patients
MeSH terms: Breast Neoplasms
Intervention: Estradiol
Intervention MeSH terms: Estradiol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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