Clinical trial · Interventional
Recombinant Human Chorionic Gonadotropin in Preventing Breast Cancer in Premenopausal Women With BRCA1 Mutations
Genomic Markers of Breast Cancer Prevention Induced by HCG in Women at High Risk
NCT00700778CI-TRIAL-00049590terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unable to recruit volunteers
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRCA1 Mutation | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| microarray analysis | Genetic | — | UNRESOLVED |
| needle biopsy | Procedure | — | UNRESOLVED |
| recombinant human chorionic gonadotropin | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Recombinant human chorionic gonadotropin
- description
- Patients receive recombinant human chorionic gonadotropin subcutaneously three times weekly. Treatment continues weekly for 90 days in the absence of unacceptable toxicity.
- interventionNames
- Biological: recombinant human chorionic gonadotropin
- Genetic: microarray analysis
- Other: immunohistochemistry staining method
- Other: laboratory biomarker analysis
- Procedure: needle biopsy
Primary outcomes (1)
- measure
- 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
- timeFrame
- 90 days and 270 days from baseline
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 40 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Asymptomatic women who have a deleterious mutation on the BRCA1 gene * Normal, no complaints, no evidence of disease * Nulliparous, never pregnant (G0P0) * No previous diagnosis of breast or ovarian cancer * No known brain metastases * Hormone receptor status not specified PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-1 OR Karnofsky PS 90-100% * Premenopausal with normal menstrual cycles and intact ovaries * Normal ovarian size report from pelvic ultrasound * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to human chorionic gonadotropin preparations or one of its excipients * No uncontrolled intercurrent illness including any of the following: * Ovarian enlargement of undetermined origin * Ovarian cysts \> 2 cm * Microcystic ovaries, which might predispose to the development of ovarian hyperstimulation syndrome * History of prior cancer other than non-melanoma skin cancer * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Severe cognitive deficit or psychiatric illness/social situations that would make her unable to give informed consent or would limit compliance with study requirements PRIOR CONCURRENT THERAPY: * At least 6 weeks since prior and no concurrent oral contraceptives or hormone-replacement therapy * No concurrent tamoxifen for chemoprevention * No concurrent participation in another chemopreventive trial for breast cancer * No concurrent medication that could interfere with this study including any of the following: * Hormonal contraceptives * Androgens * Prednisone * Thyroid hormones * Insulin * No other concurrent investigational agents * No recent treatment with follicle-stimulating hormone for assisted reproduction * No HIV-positive patients on concurrent combination antiretroviral therapy
References
Publications (0)
Data not yet available
No reference posted for this study.