Chemoprevention Trial - Anastrozole in Ductal Carcinoma In Situ (DCIS) in Postmenopausal Women
Condition: DCIS
Intervention: Anastrozole
Intervention description: 1 mg. oral every day for 2 - 4 weeks
Intervention MeSH terms: Anastrozole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Breast cancer is one of the most common cancers seriously afflicting women in the United
      States. Of the one million incident cases that are reported annually there are approximately
      193,000 new cases of breast cancer (Greenlee, 2001). Although significant advances have been
      made both in early detection and treatment of breast cancer, the impact of these on reduction
      in mortality has been modest (Peta, 2000). Furthermore, despite data implicating diet and
      other environmental risk factors, no lifestyle changes have yet been shown to significantly
      reduce the risk of breast cancer. Therefore, chemoprevention of breast cancer is a worthwhile
      approach to reduce the incidence of breast cancer.

      There is every reason to believe that a detailed understanding of the initiation, promotion
      and growth of breast cancer will ultimately provide a rational strategy upon which to base
      prevention strategies. While the pathways of breast cancer development are not yet fully
      understood, a role for estrogens in breast cancer etiology has been well established.

      While many pathways are involved in breast cancer etiology, including loss of tumor
      suppressor function by p53 or BRCA1 and gain of HER2 oncogene expression, their exact role in
      an individual patient's cancer development may vary.

      Therefore, it may be advantageous to focus on a chemoprevention strategy that may have a more
      uniform impact on breast cancer development, such as estrogen exposure. Estrogen and its
      metabolites, both in the circulation and locally synthesized in the breast, are important in
      the pathogenesis of breast cancer. High levels of circulating estrogen in postmenopausal
      women have been associated with an increased risk of breast cancer (Clemons, 2001).
      Furthermore, local estrogen synthesis, i.e. aromatase activity, in the breast may also be
      important in the development of breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have suspicion of DCIS or early invasive breast cancer on mammography.

          -  Patients must have histologically confirmed diagnosis of DCIS or early invasive breast
             cancer on core biopsy for final registration.

          -  Patients must be over 18 years of age

          -  "Patients must be postmenopausal as defined by one of the following criteria:

               1. Prior bilateral oophorectomy OR

               2. > 12 months since LMP with no prior hysterectomy OR

               3. a & b not applicable AND age >=50

          -  Patients must be positive for either ER or PR or both

          -  Patients must be informed of the investigational nature of this study and must sign
             and give written informed consent in accordance with institutional and federal
             guidelines.

        Exclusion Criteria:

          -  Patients must not have diagnosis of osteoporosis (T-score -2.5 according to the WHO)