NCT03495609

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

Completed Phase 4 Last updated 7 September 2023

What this trial tests

Phase 4 trial testing Ovitrelle in hCG in 33 participants. Completed in 18 December 2018.

Timeline

17 February 2016

Primary endpoint
18 December 2018

18 December 2018

Quick facts

Lead sponsor	University Hospital, Ghent
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	33
Start date	17 February 2016
Primary completion	18 December 2018
Estimated completion	18 December 2018
Sites	1 location across Belgium

Drugs / interventions tested

• Ovitrelle — full drug profile →

Conditions studied

• hCG — all drugs for hCG →
• BRCA1 Mutation — all drugs for BRCA1 Mutation →
• BRCA2 Mutation — all drugs for BRCA2 Mutation →

Sponsor

University Hospital, Ghent

Who can join

Adults 18 to 30, female only, with hCG or BRCA1 Mutation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Women's cancers: how the discovery of BRCA genes is driving current concepts of cancer biology and therapeutics.
   Murthy P, Muggia F. · · 2019 · cited 10× · PMID 30915162 · DOI 10.3332/ecancer.2019.904