ACTRN12614000838617
Completed
Phase 2
Investigating the Prevention of Endometrial CAncer with Metformin (PECAM Study)- a study involving postmenopausal women with hormone receptor positive breast cancer who are currently on tamoxifen therapy for at least 6 weeks.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Endometrial cancer
- Sponsor
- Monash University
- Enrollment
- 130
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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