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Trial record 3 of 31 for:    "Breast Ductal Carcinoma" | "Bone Density Conservation Agents"

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

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ClinicalTrials.gov Identifier: NCT00183963
Recruitment Status : Terminated (Insufficient accrual)
First Posted : September 16, 2005
Results First Posted : December 6, 2012
Last Update Posted : May 22, 2014
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
University of Southern California

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Carcinoma
Interventions Drug: Tamoxifen
Drug: Fulvestrant
Enrollment 4
Recruitment Details Participants were recruited from the USC+LAC General Hospital between August 2006 to April 2008.
Pre-assignment Details The study had no pre-assignment criteria.
Arm/Group Title Arm 1: Control Group Arm 2: Tamoxifen Group Arm 3: Low Dose Fulvestrant Arm 4: High Dose Fulvestrant
Hide Arm/Group Description Placebo

Tamoxifen 20 mg

Tamoxifen : 20mg daily, by mouth x 21 days

Fulvestrant 250mg

Fulvestrant : 250mg given on day 1, administered by IM Injection

Fulvestrant 500mg

Fulvestrant : 500mg given on day 1, administered by IM Injection

Period Title: Overall Study
Started 1 1 1 1
Completed 0 0 0 0
Not Completed 1 1 1 1
Arm/Group Title Arm 1: Control Group Arm 2: Tamoxifen Group Arm 3: Low Dose Fulvestrant Arm 4: High Dose Fulvestrant Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 1 1 1 1 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 1 participants 1 participants 4 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
4
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 1 participants 1 participants 4 participants
Female
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
4
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 1 participants 1 participants 4 participants
Hispanic or Latino
1
 100.0%
0
   0.0%
1
 100.0%
1
 100.0%
3
  75.0%
Not Hispanic or Latino
0
   0.0%
1
 100.0%
0
   0.0%
0
   0.0%
1
  25.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 1 participants 1 participants 4 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
1
 100.0%
0
   0.0%
0
   0.0%
1
  25.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
 100.0%
0
   0.0%
1
 100.0%
1
 100.0%
3
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 1 participants 1 participants 1 participants 4 participants
1 1 1 1 4
1.Primary Outcome
Title Number of Participants With Molecular Changes in Markers of Cell Proliferation and Apoptosis Associated With Treatment
Hide Description 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.
Time Frame 6 months after treatment of last patient enrolled
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not conducted since there was only 1 subject randomized on to each of the treatment arms.
Arm/Group Title Arm 1: Control Group Arm 2: Tamoxifen Group Arm 3: Low Dose Fulvestrant Arm 4: High Dose Fulvestrant
Hide Arm/Group Description:
Placebo
20 mg given by mouth daily for 21 days
250 mg given on day 1, administered by IM Injection
500 mg given on day 1, administered by IM Injection
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Number of Participants With Changes in Mammographic Density
Hide Description The mammograms will be scanned and a validated computer based threshold method will be used to determine the mammographic densities.
Time Frame 6 months after treatment of last patient enrolled
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not conducted since there was only 1 subject accrued on to each of the treatment arms.
Arm/Group Title Arm 1: Control Group Arm 2: Tamoxifen Group Arm 3: Low Dose Fulvestrant Arm 4: High Dose Fulvestrant
Hide Arm/Group Description:
Placebo

Tamoxifen 20 mg

Tamoxifen : 20mg daily, by mouth x 21 days

Fulvestrant 250mg

Fulvestrant : 250mg given on day 1, administered by IM Injection

Fulvestrant 500mg

Fulvestrant : 500mg given on day 1, administered by IM Injection

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 4 weeks after treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1: Control Group Arm 2: Tamoxifen Group Arm 3: Low Dose Fulvestrant Arm 4: High Dose Fulvestrant
Hide Arm/Group Description Placebo

Tamoxifen 20 mg

Tamoxifen : 20mg daily, by mouth x 21 days

Fulvestrant 250mg

Fulvestrant : 250mg given on day 1, administered by IM Injection

Fulvestrant 500mg

Fulvestrant : 500mg given on day 1, administered by IM Injection

All-Cause Mortality
Arm 1: Control Group Arm 2: Tamoxifen Group Arm 3: Low Dose Fulvestrant Arm 4: High Dose Fulvestrant
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1: Control Group Arm 2: Tamoxifen Group Arm 3: Low Dose Fulvestrant Arm 4: High Dose Fulvestrant
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/1 (0.00%)      0/1 (0.00%)      0/1 (0.00%)      0/1 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1: Control Group Arm 2: Tamoxifen Group Arm 3: Low Dose Fulvestrant Arm 4: High Dose Fulvestrant
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/1 (0.00%)      1/1 (100.00%)      0/1 (0.00%)      1/1 (100.00%)    
Gastrointestinal disorders         
Vomiting * 1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1
General disorders         
Injection site reaction/extravasation changes  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1
Nervous system disorders         
Headache * 1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1
Skin and subcutaneous tissue disorders         
Sweating (diaphoresis) * 1  0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0
Vascular disorders         
Hot flashes * 1  0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Due to insufficient accrual, analysis was not conducted.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Victoria Soto, Project Specialist, Clinical Investigations Support Office
Organization: USC Norris Comprehensive Cancer Center
Phone: 323-226-6384
EMail: Victoria.Soto@med.usc.edu
Layout table for additonal information
Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00183963     History of Changes
Other Study ID Numbers: 1B-03-7
First Submitted: September 12, 2005
First Posted: September 16, 2005
Results First Submitted: November 9, 2012
Results First Posted: December 6, 2012
Last Update Posted: May 22, 2014