Trial Outcomes & Findings for Recombinant Human Chorionic Gonadotropin in Preventing Breast Cancer in Premenopausal Women With BRCA1 Mutations (NCT NCT00700778)
NCT ID: NCT00700778
Last Updated: 2021-01-25
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
2 participants
Primary outcome timeframe
90 days and 270 days from baseline
Results posted on
2021-01-25
Participant Flow
Participant milestones
| Measure |
Recombinant Human Chorionic Gonadotropin
Patients receive recombinant human chorionic gonadotropin subcutaneously three times weekly. Treatment continues weekly for 90 days in the absence of unacceptable toxicity.
recombinant human chorionic gonadotropin
microarray analysis
immunohistochemistry staining method
laboratory biomarker analysis
needle biopsy
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Recombinant Human Chorionic Gonadotropin
Patients receive recombinant human chorionic gonadotropin subcutaneously three times weekly. Treatment continues weekly for 90 days in the absence of unacceptable toxicity.
recombinant human chorionic gonadotropin
microarray analysis
immunohistochemistry staining method
laboratory biomarker analysis
needle biopsy
|
|---|---|
|
Overall Study
Inconclusive data due to inadequate sample collection
|
2
|
Baseline Characteristics
Recombinant Human Chorionic Gonadotropin in Preventing Breast Cancer in Premenopausal Women With BRCA1 Mutations
Baseline characteristics by cohort
| Measure |
Recombinant Human Chorionic Gonadotropin
n=2 Participants
Patients receive recombinant human chorionic gonadotropin subcutaneously three times weekly. Treatment continues weekly for 90 days in the absence of unacceptable toxicity.
recombinant human chorionic gonadotropin
microarray analysis
immunohistochemistry staining method
laboratory biomarker analysis
needle biopsy
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 90 days and 270 days from baselinePopulation: No results were obtained
Outcome measures
Outcome data not reported
Adverse Events
Recombinant Human Chorionic Gonadotropin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place