A Pre-Operative Window Study of Tirzepatide in Obesity-Driven Endometrial Cancer
LCCC2415 examines the antiproliferative effect of tirzepatide on the endometrium of endometrial cancer (EC). This is a pre-operative window clinical study. Endometrial biopsy samples from patients before tirzepatide treatment will be compared to their post-intervention hysterectomy specimens. If archival tissue is unavailable, a fresh biopsy will be taken before tirzepatide treatment. Post-intervention tissue will be collected from the hysterectomy specimen. The hypothesis is that tirzepatide's anti-tumorigenic effects are due to both an improvement in the host's metabolic milieu (indirect effect) and a direct effect on the EC tumor microenvironment via the inter-related pathways of insulin, lipid, and mTOR signaling. Therefore, tirzepatide may be an innovative approach to effectively induce weight loss and inhibit tumor growth in EC, the most obesity-driven of all cancers.
• Current diagnosis of endometrioid histology cancer and scheduled to undergo hysterectomy and staging.
• Agree to comply with all required study assessments and visits including internet capabilities.
• Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
• Age ≥ 18 at the time of consent.
• Body mass index of ≥30 kg/m2.
• Presumed clinically early-stage disease (disease confined to uterus only).
• ECOG ≤ 2 or Karnofsky Performance Status of \> 50