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Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium — WE-FiERCE  

Endometrial Cancer Clinical Trial

Official title:
Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium (WE-FiERCE)

Clinical Trial Summary

The incidence of endometrial cancer is increasing at an alarming rate. This trend parallels the rising rate of obesity, the most significant risk factor for endometrial cancer. Young women with obesity and endometrial cancer or atypical hyperplasia who want to maintain their fertility are treated with progestin therapy, such as progestin intra-uterine device (pIUD), which is associated with a mediocre response rate and high recurrence rate, and does not address the underlying cause, obesity. Therefore, the investigators want to assess whether the addition of a weight-loss drug to pIUD will improve their oncologic, reproductive and metabolic outcomes.

Clinical Trial Description

The research aims to answer the question: "Does the addition of Glucagon-like Peptide-1 (GLP-1) agonist to standard progestin treatment lead to a higher complete response rate compared to historical response rates using progestin alone in young patients with endometrial cancer/atypical hyperplasia who wish to preserve their fertility?". This is a multicentre single arm, historically controlled, open-label phase 2 study to assess the safety and efficacy of the combination of semaglutide (GLP-1) and pIUD. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06073184
Study type Interventional
Source University Health Network, Toronto
Contact Vanessa Ballin
Phone 416-946-4501
Email vanessa.ballin@uhn.ca
Status Not yet recruiting
Phase Phase 2
Start date September 2024
Completion date September 2031
View Details
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