Investigating the Prevention of Endometrial CAncer with Metformin (PECAM Study)

Phase 2

Completed

• Conditions: Endometrial cancer; Breast cancer; Cancer - Womb (Uterine or endometrial cancer); Cancer - Breast

• Registration Number: ACTRN12614000838617
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

Postmenopausal women, aged < 75 years, who are currently taking tamoxifen therapy for at least 6 weeks for treatment of hormone receptor positive breast cancer.

Exclusion Criteria

1.Women who are premenopausal / perimenopausal / > 75 years old
2.Women with advanced breast cancer and likely to have progression of their disease within the study period, as assessed by their treating oncologist.

3.Women with any of the following on screening:

a)Use of any systemic hormones in the last 6 months;
b) serious endocrine disorder with systemic disease;
c) alcohol consumption greater than 3 standard drinks per day;
d) known acute or chronic renal, liver disease or cardiovascular disease;
e) insulin dependent diabetes mellitus or use of an oral hypoglycemic agent;

4. <6 months amenorrhoea so that the likelihood of ovulatory cycles during the study will be small.

5. EH with atypia or ECa on endometrial biopsy or hysteroscopy and curettage.
6. Women who, in the opinion of the investigator, are a poor medical or psychiatric risk for treatment in a research protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the effect of metformin therapy on the expression of genes in endometrial tissue on biopsy encoding:<br>1)proteins in the LKB1/AMPK pathway, which inhibits cell proliferation; <br>2)mammalian target of rapamycin (mTOR), which stimulates endometrial growth;<br>3)the cytochrome P450 enzyme, aromatase, which is essential for oestrogen biosynthesis in the endometrium, and hence endometrial growth.<br>These are co-primary outcomes as they are dependent variables<br>[12 months]

Secondary Outcome Measures

Name	Time	Method
The effects of metformin, versus placebo, after 52 weeks of treatment on endometrial thickness, assessed by TVU+ saline infusion sonohysterography (SIS), and development of any other endometrial abnormalities on TVU (polyps, hyperplasia, subendometrial thickening or fibroids).<br><br><br>[12 months];The effects of metformin, versus placebo, after 52 weeks of treatment on endometrial histopathology of the endometrial biopsy tissue.[12 months]; Associations between the effects of metformin on the endometrium ( by transvaginal ultrasound) and clinical characteristics and biochemistry, including fasting glucose, insulin, adiponectin and leptin ( by blood tests).[12 months];The association between TVU+SIS findings and endometrial pathology on biopsy.[12 months]