Trial Outcomes & Findings for A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant in Breast Ductal Carcinoma in Situ (DCIS) (NCT NCT00183963)
NCT ID: NCT00183963
Last Updated: 2014-05-22
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
6 months after treatment of last patient enrolled
Results posted on
2014-05-22
Participant Flow
Participants were recruited from the USC+LAC General Hospital between August 2006 to April 2008.
The study had no pre-assignment criteria.
Participant milestones
| Measure |
Arm 1: Control Group
Placebo
|
Arm 2: Tamoxifen Group
Tamoxifen 20 mg
Tamoxifen : 20mg daily, by mouth x 21 days
|
Arm 3: Low Dose Fulvestrant
Fulvestrant 250mg
Fulvestrant : 250mg given on day 1, administered by IM Injection
|
Arm 4: High Dose Fulvestrant
Fulvestrant 500mg
Fulvestrant : 500mg given on day 1, administered by IM Injection
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant in Breast Ductal Carcinoma in Situ (DCIS)
Baseline characteristics by cohort
| Measure |
Arm 1: Control Group
n=1 Participants
|
Arm 2: Tamoxifen Group
n=1 Participants
|
Arm 3: Low Dose Fulvestrant
n=1 Participants
|
Arm 4: High Dose Fulvestrant
n=1 Participants
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
4 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 months after treatment of last patient enrolledPopulation: Analysis was not conducted since there was only 1 subject randomized on to each of the treatment arms.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months after treatment of last patient enrolledPopulation: Analysis was not conducted since there was only 1 subject accrued on to each of the treatment arms.
The mammograms will be scanned and a validated computer based threshold method will be used to determine the mammographic densities.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1: Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2: Tamoxifen Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm 3: Low Dose Fulvestrant
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 4: High Dose Fulvestrant
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1: Control Group
n=1 participants at risk
Placebo
|
Arm 2: Tamoxifen Group
n=1 participants at risk
Tamoxifen 20 mg
Tamoxifen : 20mg daily, by mouth x 21 days
|
Arm 3: Low Dose Fulvestrant
n=1 participants at risk
Fulvestrant 250mg
Fulvestrant : 250mg given on day 1, administered by IM Injection
|
Arm 4: High Dose Fulvestrant
n=1 participants at risk
Fulvestrant 500mg
Fulvestrant : 500mg given on day 1, administered by IM Injection
|
|---|---|---|---|---|
|
Vascular disorders
Hot flashes
|
0.00%
0/1 • 4 weeks after treatment
|
100.0%
1/1 • Number of events 1 • 4 weeks after treatment
|
0.00%
0/1 • 4 weeks after treatment
|
0.00%
0/1 • 4 weeks after treatment
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
0.00%
0/1 • 4 weeks after treatment
|
100.0%
1/1 • Number of events 1 • 4 weeks after treatment
|
0.00%
0/1 • 4 weeks after treatment
|
0.00%
0/1 • 4 weeks after treatment
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • 4 weeks after treatment
|
0.00%
0/1 • 4 weeks after treatment
|
0.00%
0/1 • 4 weeks after treatment
|
100.0%
1/1 • Number of events 1 • 4 weeks after treatment
|
|
General disorders
Injection site reaction/extravasation changes
|
0.00%
0/1 • 4 weeks after treatment
|
0.00%
0/1 • 4 weeks after treatment
|
0.00%
0/1 • 4 weeks after treatment
|
100.0%
1/1 • Number of events 1 • 4 weeks after treatment
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • 4 weeks after treatment
|
0.00%
0/1 • 4 weeks after treatment
|
0.00%
0/1 • 4 weeks after treatment
|
100.0%
1/1 • Number of events 1 • 4 weeks after treatment
|
Additional Information
Victoria Soto, Project Specialist, Clinical Investigations Support Office
USC Norris Comprehensive Cancer Center
Phone: 323-226-6384
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place