A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant in Breast Ductal Carcinoma in Situ (DCIS)
Condition: Breast Carcinoma
MeSH terms: Carcinoma; Breast Neoplasms; Carcinoma in Situ; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating; Carcinoma, Ductal, Breast
Intervention: Tamoxifen; Fulvestrant; Fulvestrant
Intervention description: 20mg; 250mg; 500 mg IM
Intervention MeSH terms: Tamoxifen; Fulvestrant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The subjects in this trial have been diagnosed as having a pre-cancerous disease of the
      breast called ductal carcinoma in situ (DCIS). This condition is associated with the
      development of breast cancer in up to 50% of cases.

      The subjects are being asked to participate in this research study. They are being offered
      voluntary admission to this study to test the effects of a new investigational drug called
      Fulvestrant (Faslodex). This drug is approved by the United States Food and Drug
      Administration (FDA) for the treatment of advanced breast cancer but has not been approved
      for the treatment of DCIS. However, the FDA has given permission for the drug to be tested in
      this study. The purpose of this study is to find out if Fulvestrant has any effect on the
      subject's precancerous changes by comparing samples taken before and after receiving
      Fulvestrant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women with newly diagnosed DCIS. Women will be considered to be in
             menopause if they fall into one of the following groups:

               -  Age > 60

               -  Age > 45 with amenorrhea > 1 year with intact uterus

               -  Status post bilateral oophorectomies

               -  FSH/estradiol levels in postmenopausal range for the institution

          -  DCIS must have been diagnosed with a minimally invasive biopsy technique, such as a
             vacuum-assisted large core tool (Mammotome) or an equivalent method.

          -  There must be available tissue from the diagnostic biopsy to perform molecular
             markers.

          -  Baseline mammogram within 8 weeks of study entry.

          -  Serum creatinine less than or equal to 2.0 mg/dl.

          -  Total bilirubin less than or equal to 2.0 upper limit of normal (ULN), transaminases
             (SGOT and/or SGPT) and alkaline phosphatase may be up to 2.5 x institutional upper
             limit of normal (ULN), AGC greater than or equal to 1500, platelets greater than or
             equal to 100,000, Hemoglobin greater than or equal to 8.0 g/dl

          -  Peripheral neuropathy grade 0-1.

          -  No prior therapy for DCIS.

          -  SWOG performance status of less than or equal to 1

          -  All patients must provide informed written consent

        Exclusion Criteria:

          -  Prior hormonal therapy (antiestrogens, estrogen, SERM's, progestins, or aromatase
             inhibitors) within 6 months of study entry.

          -  Underlying medical, psychiatric or social conditions that would preclude patient from
             receiving treatment.

          -  History of DVT or Pulmonary Embolism