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

NCT03495609 | Completed Phase 4

• 1 other identifier: 2015-001720-36
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Does Ovitrelle result in early prevention of breast cancer in BRCA1 and BRCA2 carriers?

  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.

  48 weeks

Secondary Outcomes (1)

• Does Ovitrelle result in early prevention of breast cancer in BRCA1 and BRCA2 carriers?

  60 weeks

Study Arms (1)

Ovitrelle

EXPERIMENTAL

Drug: Ovitrelle

Interventions

Ovitrelle DRUG

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.

Ovitrelle

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: Only females who are BRCA1 or BRCA2 carriers and who are premenopausal will be included
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• premenopausal women
• BRCA1 carrier

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Fox Chase Cancer Center: collaborator
• Ziekenhuis Oost-Limburg: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, East-Flanders, 9000, Belgium

Location

MeSH Terms

Interventions

Chorionic Gonadotropin

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins

Study Officials

• Jose Russo, Prof.

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: April 12, 2018
• Study Start: February 17, 2016
• Primary Completion: December 18, 2018
• Study Completion: December 18, 2018
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)