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Clinical Trials/ACTRN12614000838617
ACTRN12614000838617CompletedPhase 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.

Monash University0 sites130 target enrollmentStarted: August 7, 2014Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
130

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomised controlled trial
Primary Purpose
Prevention
Masking
Blinded (masking used)

Eligibility Criteria

Ages
18 Years to 74 Years (—)
Sex
Female

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.

Investigators

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