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Insufficient accrual
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | No Intervention | ||
| 2 | Active Comparator | Tamoxifen 20 mg |
|
| 3 | Active Comparator | Fulvestrant 250mg |
|
| 4 | Active Comparator | Fulvestrant 500mg IM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamoxifen | Drug | 20mg |
| |
| Fulvestrant |
| 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 |
| 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 |
Not provided
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Holmes | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
The study had no pre-assignment criteria.
Participants were recruited from the USC+LAC General Hospital between August 2006 to April 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Control Group | Placebo |
| FG001 | Arm 2: Tamoxifen Group | Tamoxifen 20 mg Tamoxifen : 20mg daily, by mouth x 21 days |
| FG002 | Arm 3: Low Dose Fulvestrant | Fulvestrant 250mg Fulvestrant : 250mg given on day 1, administered by IM Injection |
| FG003 | Arm 4: High Dose Fulvestrant | Fulvestrant 500mg Fulvestrant : 500mg given on day 1, administered by IM Injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Control Group | |
| BG001 | Arm 2: Tamoxifen Group | |
| BG002 | Arm 3: Low Dose Fulvestrant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis was not conducted since there was only 1 subject randomized on to each of the treatment arms. | Posted | 6 months after treatment of last patient enrolled |
|
4 weeks after treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Control Group | Placebo |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hot flashes | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
Due to insufficient accrual, analysis was not conducted.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Victoria Soto, Project Specialist, Clinical Investigations Support Office | USC Norris Comprehensive Cancer Center | 323-226-6384 | Victoria.Soto@med.usc.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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| Drug |
250mg |
|
| Fulvestrant | Drug | 500 mg IM |
|
| BG003 | Arm 4: High Dose Fulvestrant |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 |
| Arm 3: Low Dose Fulvestrant |
250 mg given on day 1, administered by IM Injection |
| OG003 | Arm 4: High Dose Fulvestrant | 500 mg given on day 1, administered by IM Injection |
|
| Secondary | 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. | Analysis was not conducted since there was only 1 subject accrued on to each of the treatment arms. | Posted | 6 months after treatment of last patient enrolled |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Arm 2: Tamoxifen Group | Tamoxifen 20 mg Tamoxifen : 20mg daily, by mouth x 21 days | 0 | 1 | 1 | 1 |
| EG002 | Arm 3: Low Dose Fulvestrant | Fulvestrant 250mg Fulvestrant : 250mg given on day 1, administered by IM Injection | 0 | 1 | 0 | 1 |
| EG003 | Arm 4: High Dose Fulvestrant | Fulvestrant 500mg Fulvestrant : 500mg given on day 1, administered by IM Injection | 0 | 1 | 1 | 1 |
| Sweating (diaphoresis) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Injection site reaction/extravasation changes | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
Not provided
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| D017437 |
| Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |