An interventional study of recombinant human chorionic gonadotropin and microarray analysis in BRCA1 Mutation and Breast Cancer, sponsored by Fox Chase Cancer Center. Terminated at 3 sites in 2 countries. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2021-01-25.
Sponsored by Fox Chase Cancer Center · Not applicable, Interventional, and Prevention
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of recombinant human chorionic gonadotropin may prevent breast cancer in premenopausal women with BRCA1 mutations.
PURPOSE: This clinical trial is studying recombinant human chorionic gonadotropin in preventing breast cancer in premenopausal women with BRCA1 mutations.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive recombinant human chorionic gonadotropin subcutaneously three times weekly. Treatment continues weekly for 90 days in the absence of unacceptable toxicity.
Benign breast tissue specimens are collected by core needle biopsy at baseline, day 90, and day 270. Tissue samples are analyzed by cytopathology for epithelial normality, Ki67 immunohistochemical staining for cell proliferation, cDNA microarray for gene expression, and serum studies for hormone levels and biomarker determinations.
After completion of study treatment, patients are followed for 24 weeks.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 2 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Fox Chase Cancer Center is the lead sponsor of 211 studies on the registry; 30 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 8 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness including any of the following:
PRIOR CONCURRENT THERAPY:
No concurrent medication that could interfere with this study including any of the following:
Patients receive recombinant human chorionic gonadotropin subcutaneously three times weekly. Treatment continues weekly for 90 days in the absence of unacceptable toxicity.
Biological: recombinant human chorionic gonadotropin · Genetic: microarray analysis · Other: immunohistochemistry staining method · Other: laboratory biomarker analysis · Procedure: needle biopsy
Measurement of Gene Expression in Breast Epithelial Cells Obtained for Asymptomatic High Breast Cancer Risk Nulliparous Premenopausal Women at Baseline, After Treatment With r-hCG at 90 Days, and at 270 Days From Baseline
Time frame: 90 days and 270 days from baseline
| Milestone | Recombinant Human Chorionic Gonadotropin |
|---|---|
| Started | 2 |
| Completed | 0 |
| Not completed | 2 |
| Withdrew: Inconclusive data due to inadequate sample collection | 2 |
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Recombinant Human Chorionic Gonadotropin | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
No results were obtained
| Age, Categorical(Participants) | Recombinant Human Chorionic Gonadotropin |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 2 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Recombinant Human Chorionic Gonadotropin |
|---|---|
| Female | 1 |
| Male | 1 |
| Region of Enrollment(participants) | Recombinant Human Chorionic Gonadotropin |
|---|---|
| Austria | 1 |
This study is terminated, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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