Aromatase Inhibitors in Premenopausal Breast Cancer Patients With Chemotherapy-Induced Ovarian Failure
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: anastrozole
Intervention description: 1 mg tablet by mouth once a day
Intervention MeSH terms: Anastrozole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: Female
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: premenopausal breast cancer with chemotherapy-induced ovarian failure

Summary:

      Women with hormone-receptor positive breast cancer are typically treated with hormone therapy
      as part of their treatment after surgery. In the past few years it has been found that
      treatment with aromatase inhibitors is superior to tamoxifen in postmenopausal women.
      Tamoxifen is still used for premenopausal women, however, because aromatase inhibitors are
      not effective in women who have functioning ovaries. Some women are premenopausal at the time
      they are diagnosed with breast cancer, but then stop having menstrual periods when they are
      treated with chemotherapy. It is unclear if these women can also be treated safely with
      aromatase inhibitors.

      In this clinical trial the researchers will try to answer this question. Women with hormone
      receptor positive breast cancer who become postmenopausal with chemotherapy will be invited
      to participate in this study. Each woman will be treated with one of the aromatase
      inhibitors, anastrozole (Arimidex), and then carefully monitored to ensure that her ovaries
      do not start making estrogen. If her estrogen level remains low, then she will continued to
      be followed for 18 months. If the level increases to the level typically seen in
      premenopausal women, however, then she will stop taking part in this study.

      The study will also evaluate multiple factors that may help doctors predict who will tolerate
      the therapy without having their ovaries start making estrogen again. Some of the factors to
      be evaluated include other hormone levels (blood tests) as well as family history of early
      menopause (mother, sisters). In addition, changes in certain genes that affect how patients'
      bodies handle chemotherapy drugs will be tested to see if they affect whether or not patients
      recover ovarian function. Overall, the purpose of the study is to determine which patients
      who become postmenopausal from chemotherapy are likely to tolerate aromatase inhibitor
      treatment safely, and how often the patients' ovarian function needs to be tested during
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

        To be eligible for this study:

          1. You must be at least 18 years of age and not older than 60 years of age

          2. You have breast cancer which was confined to the breast and lymph nodes under the arm,
             and have no evidence of cancer elsewhere

          3. You must have had surgical removal of your tumor, and if indicated, radiation therapy
             must have been completed or planned

          4. Your tumor must express estrogen and/or progesterone receptors

          5. You must have had a menstrual period within 6 months before starting chemotherapy for
             your breast cancer.

          6. You must have been treated with a chemotherapy regimen that includes cyclophosphamide
             (Cytoxan). Your menstrual periods must have stopped for at least 8 weeks starting
             during or after chemotherapy.

        Exclusion Criteria:

        You are not eligible to participate in this study if:

        1. Your ovaries have been surgically removed, treated with radiation therapy, or if you are
        taking medications (Zoladex™ or Lupron™) to block the function of your ovaries.