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Completed

NCT Number: NCT05053841

Implication of Metformin Plus Aromatase Inhibitor in Obese Postmenopausal Breast Cancer Women

Metformin is an anti-diabetic oral hypoglycemic agent that considered the gold standard therapy for the treatment of type 2 diabetes. Retrospective analyses show that metformin can offer therapeutic benefits to patients with several forms of cancer. It also has positive weight reducing effect on non-diabetic patient by improving insulin sensitivity (although the exact underlying pathomechanisms remain to be elucidated).

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Key information

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

About this study

This prospective controlled study aimed to evaluate the effect of combined metformin adjuvant therapy and aromatase inhibitors (letrozole) in postmenopausal obese breast cancer women. In addition, to evaluate the effect of weight reduction on aromatase inhibitor efficacy.

Patients and methods: From February 2014 to June 2015, 75 Post-menopausal breast cancer females' patients were recruited, 53 patients underwent randomization and 45 patients completed six months, treatment. Aromatase inhibitor (letrozole) was administered as once daily in accordance to one of the three groups. Control group: fifteen obese females who received letrozole only; metformin group: fifteen obese females who received the same dose of letrozole plus metformin (2000 ± 500) mg daily, and lean group: fifteen non- obese breast cancer females who received letozole for six months, treatment period. Blood samples were collected at baseline and after six months of aromatase inhibitors treatment for analysis of serum estradiol, osteocalcin, insulin, leptin, lactate and glucose.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Postmenopausal women, postmenopausal is defined either by:

A. Age ≥ 55 years and one year or more of amenorrhea. B. Age < 55 years and one year or more of amenorrhea, with an estradiol assay < 20 pg/ml.

  • Patients with breast cancer indicated for hormonal treatment with aromatase inhibitors (overweight 30 > BMI ≥ 25, obese BMI ≥ 30 kg/m2 and non obese BMI between 18 and 25 kg/m2).

Exclusion criteria

  • • Diabetic patients.
  • Patients with metabolic syndrome.
  • Patients with last menstrual cycle less than one year ago.
  • Patient with conditions predispose to acidosis (heart failure, renal failure).
  • Ovarian radiation treatment with luteinizing hormone-releasing hormone (LH-RH) agonist (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression.

Treatment and study plan

metformin

Drug

Other names: Glucophage

Primary outcomes

  1. change in serum level of the study biomarkers after treatment when compared with baseline values

    Time frame: six months

    measuring the serum levels of the studied biomarkers

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Implication of Combined Adjuvant Metformin and Aromatase Inhibitor in Overweight or Obese Postmenopausal Breast Cancer Women

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 23, 2021
Registry last updated
Sep 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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