MedTrace Logo

Use of Recombinant hCG to Prevent Breast Cancer in BRCA1 and BRCA2 Carriers

NCT03495609 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2023-09-07

No results posted yet for this study

Summary

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

  • hCG
  • BRCA1 Mutation
  • BRCA2 Mutation

Interventions

DRUG

Ovitrelle

Ovitrelle will be injected in 35 asymptomatic women with BRCA1 or BRCA2 mutation during 90 days (an extra 4 weeks in a subgroup). The gene expression of the breast epithelial cells will be characterized and compared to the gene expression of the breast epithelial cells before ovitrelle injection.

Sponsors & Collaborators

  • Fox Chase Cancer Center

    collaborator OTHER

  • Ziekenhuis Oost-Limburg

    collaborator OTHER

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Jose Russo, Prof. · Fox Chase Cancer Center

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-17
Primary Completion
2018-12-18
Completion
2018-12-18

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03495609 on ClinicalTrials.gov