Trial Outcomes & Findings for Examination of Breast Cancer Cells of Pre-menopausal and Post-menopausal Women Before and After Exposure to Tamoxifen or Fulvestrant. (NCT NCT02936206)
NCT ID: NCT02936206
Last Updated: 2021-05-19
Results Overview
The change in proliferation index as measured by the percentage of cells staining for Ki67 at 2 weeks as compared on baseline.
TERMINATED
PHASE1
2 participants
baseline and 2 weeks
2021-05-19
Participant Flow
Participant milestones
| Measure |
Fulvestrant
750 mg injection in 3 divided doses
Fulvestrant: fulvestrant 750 mg (three 5 ml injections slowly over 1-2 mn per injection in the buttocks) on day 1 only
|
Tamoxifen
20mg orally
Tamoxifen: 14 days of treatment with tamoxifen 20mg orally each day
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
2
|
|
Overall Study
COMPLETED
|
0
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Examination of Breast Cancer Cells of Pre-menopausal and Post-menopausal Women Before and After Exposure to Tamoxifen or Fulvestrant.
Baseline characteristics by cohort
| Measure |
Fulvestrant
750 mg injection in 3 divided doses
Fulvestrant: fulvestrant 750 mg (three 5 ml injections slowly over 1-2 mn per injection in the buttocks) on day 1 only
|
Tamoxifen
n=2 Participants
20mg orally
Tamoxifen: 14 days of treatment with tamoxifen 20mg orally each day
|
Total
n=2 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
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 2 weeksPopulation: With the 2 patients enrolled on the trial, the data collected was insufficient and not evaluable.
The change in proliferation index as measured by the percentage of cells staining for Ki67 at 2 weeks as compared on baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline and 2 weeksPopulation: With the 2 patients enrolled on the trial, the data collected was insufficient and not evaluable.
The change in estrogen receptor level at 2 weeks as compared to baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline and 2 weeksPopulation: With the 2 patients enrolled on the trial, the data collected was insufficient and not evaluable.
The change in progesterone receptor level at 2 weeks as compared to baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeksPopulation: With the 2 patients enrolled on the trial, the data collected was insufficient and not evaluable.
Number of tamoxifen-resistance gene expression signature observed in patients with cyclinD1 overexpressing breast cancers.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeksPopulation: With the 2 patients enrolled on the trial, the data collected was insufficient and not evaluable.
Number of fulvestrant-sensitivity gene expression signature observed in patients with cyclinD1 overexpressing breast cancers.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeksPopulation: With the 2 patients enrolled on the trial, the data collected was insufficient and not evaluable.
For samples that are available for culture in vivo, proliferation assay to test whether the cells derived from individual patients respond the same as the tumor in vivo in the same patient.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeksPopulation: With the 2 patients enrolled on the trial, the data collected was insufficient and not evaluable.
Differential treatment effect for pre and post menopausal subjects assessed by the mean change in levels (expressed as a percentage of cells staining positive within the breast tumor) of ER (and PR) between pre-treatment and post-treatment stratified by menopausal status.
Outcome measures
Outcome data not reported
Adverse Events
Fulvestrant
Tamoxifen
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Amy Tiersten
Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place