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

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