A Phase II Randomised Clinical Trial of Mirena® ± Metformin ± Weight

Loss in Patients with Early Stage Cancer of the Endometrium

Study Chair: Andreas ObermairTrial Manager: Fiona MenziesTrial Coordinator: Kerry Millgate

BackgroundEndometrial cancer common in AUS Becoming increasingly common in young

women still desiring fertility Becoming common in elderly patients

suffering from significant medical co-morbidities (increased surgical risks)

Problem area: Super obese patients Surgical complications high Conversion to open surgery high Hospital stay + Costs significant

Adverse events are common

Morbidly obese woman EAC FIGO g1, no myoinvasion

Respiratory failure secondary to pneumonia

Unplanned ICU admission on day 5; Requires ventilation, imaging, i.v. ABs

Treatment alternative is availabale

Progestins offered on case-to-case basis

(Mirena ± oral progestins)

Study Objectives Primary: To determine the efficacy of Mirena

IUD ± Metformin ± Weight Loss to achieve a pathological complete response (pCR) in endometrial cancer at 6 months from study treatment start.

Secondary: Endometrial cancer biomarkers will be assessed at different time points to enhance our understanding of the molecular processes and to predict a treatment response.

Study Endpoints Primary: Pathological Complete Response

Secondary: To predict the response to treatment through clinical, blood and tissue molecular biomarkers and to increase our molecular understanding of the biological pathogenesis of “early” EAC.

Schema of patient flow through study

Mirena ± Metformin ± Weight Loss

feMME Trial - EligibilityTarget: 95 ± 75 patients with complex

endometrial hyperplasia with atypia or grade 1 EAC

Eligibility: Complex Endometrial Hyperplasia with atypia

OR Grade 1 EAC – avoid enrolling patients with advanced disease

who need expedited surgery

Patients at high surgical risks or wish to retain fertility

BMI > 30 kg/m2 CT scan: absence of extrauterine disease MRI: Myometrial invasion <50% Serum CA125 ≤30 U/mL

ContactAndreas Obermair: obermair@powerup.com.auAcknowledgements: QUT (M Janda), ANZGOG (RAC, Val Gebski)Endorsed by ANZGOG and ASGONational Ethics Application (covers NSW, VIC)QCGC will facilitate HREC applications in other states