Clinical trial · Interventional
Use of Recombinant hCG to Prevent Breast Cancer in BRCA1 and BRCA2 Carriers
The Use of Recombinant hCG to Prevent Breast Cancer in BRCA1 and BRCA2 Carriers
NCT03495609CI-TRIAL-00069406completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Specific aim: To establish the proof of principle that treatment of "high breast cancer risk" women with recombinant human chorionic gonadotropin (r-hCG) will change their breast epithelium's high risk genomic profile to one similar to that identified in women with a history of early full first term pregnancy.
Conditions
Conditions (3)
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 | — |
| BRCA2 Mutation | — | UNRESOLVED | — |
| hCG | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ovitrelle | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ovitrelle
- interventionNames
- Drug: Ovitrelle
Primary outcomes (1)
- measure
- Does Ovitrelle result in early prevention of breast cancer in BRCA1 and BRCA2 carriers?
- timeFrame
- 48 weeks
- description
- The investigators are expecting that r-hCG is inducing genomic signature of protection in the breast. Participants will receive a subcutaneous injection of recombinant hCG three times a week for 12 (or 16) weeks. Normal breast tissue specimens will be collected by Spirotome at the beginning of treatment (day 0), at the end of treatment (week 13) and at 36 weeks. The specimens will be primarily utilized for analysis of genomic expression by cDNA microarray, RNA sequencing and epigenomic studies. In addition, a series of surrogate intermediate markers such as cytomorphologic evaluation and cell proliferation index will be analyzed. The primary objective is to compare the gene expression, and epigenomic profiles of sampled breast epithelial cells across the three time points and identify differentially expressed or silenced genes.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * premenopausal women * BRCA1 carrier Exclusion Criteria: * History of allergic reaction to compounds of similar chemical or biologic composition to hCG * receiving medication that could interfere with the study protocol objectives (hormonal contraceptives, androgens, prednisone, thyroid hormones, insulin) * previous treatment with follicle stimulating hormone for assisted reproduction * uncontrolled intercurrent illness * Heart disease * Severe cognitive decline * Psychiatric desease * HIV positive * Hepatitis B or C infection
References
Publications (0)
Data not yet available
No reference posted for this study.