Conditions: Breast Carcinoma
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 4
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: Tamoxifen 20 mg arm 3: Fulvestrant 250mg arm 4: Fulvestrant 500mg IM

Interventions: intervention 1: Tamoxifen intervention 2: Fulvestrant intervention 3: Fulvestrant
Intervention descriptions: intervention 1: 20mg intervention 2: 250mg intervention 3: 500 mg IM

Protocol document: