A Pre-Surgical PK Study of IM and Intraductally Delivered Fulvestrant

Inclusion Criteria

• Female
• 18 years of age or older
• Scheduled to undergo non-nipple sparing mastectomy for Invasive Breast Cancer or DCIS
• Pathological diagnosis of Invasive Ductal Breast Cancer or Ductal Carcinoma in Situ requiring mastectomy or lumpectomy
• Estrogen Receptor-positive pathology
• ECOG performance scale of 0-1
• Adequate organ function as defined by the following criteria:
• Absolute neutrophil count (ANC) ≥ 1500/μl
• Platelets ≥ 100,000/μl
• Hemoglobin ≥ 9.0 g/dl
• Creatinine ≤ 2 times upper limit of normal
• Bilirubin ≤ 2 times upper limit of normal
• Transaminases (AST/SGOT and ALT/SGPT) ≤ 2.5 times upper limit of normal
• Able to sign informed consent
• Willing to use effective contraception for at least 100 days post study drug administration.

Exclusion Criteria

• Concurrent treatment with another anti-estrogen
• Presence of an active infection requiring systemic therapy
• The following conditions contra-indicating fulvestrant administration:
• Subjects with bleeding diatheses, thrombocytopenia or current anticoagulant use (excluding aspirin and anti-inflammatories)
• Subjects with a known hypersensitivity to fulvestrant or any of its formulation components including castor oil, alcohol, benzyl alcohol, and benzyl benzoate.
• Severe hepatic impairment.
• Prior surgery on the ipsilateral breast which interrupts communication of the ductal systems with the nipple
• Prior radiation to the breast
• Pregnant or lactating
• Impaired cardiac function or history of cardiac problems of NYHA Class 111 and IV
• Poor nutritional state as indicated by a BMI below 20.
• Presence of serious infection not controlled with systemic therapy
• History of allergies to Lidocaine or Novocain
• Concurrent participation in an experimental drug study