A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant in Breast Ductal Carcinoma in Situ (DCIS)

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