A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant in Breast Ductal Carcinoma in Situ (DCIS)
Breast Carcinoma
About this trial
This is an interventional treatment trial for Breast Carcinoma
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
Sites / Locations
- Norris Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
No Intervention
Active Comparator
Active Comparator
Active Comparator
1
2
3
4
Tamoxifen 20 mg
Fulvestrant 250mg
Fulvestrant 500mg IM