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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Carcinoma

Intervention / Treatment
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* Drug: Tamoxifen
* Drug: Fulvestrant
* Drug: Fulvestrant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br> | |
| Active Comparator: 2<br>Tamoxifen 20 mg | Drug: Tamoxifen<br>* 20mg<br>|
| Active Comparator: 3<br>Fulvestrant 250mg | Drug: Fulvestrant<br>* 250mg<br>|
| Active Comparator: 4<br>Fulvestrant 500mg IM | Drug: Fulvestrant<br>* 500 mg IM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Molecular Changes in Markers of Cell Proliferation and Apoptosis Associated With Treatment | Molecular measures of effect will be measured in tissue obtained at baseline biopsy (paraffin specimen) and on surgical specimen obtained at end of 3 weeks of treatment. | 6 months after treatment of last patient enrolled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Changes in Mammographic Density | The mammograms will be scanned and a validated computer based threshold method will be used to determine the mammographic densities. | 6 months after treatment of last patient enrolled |