NCT05053841

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Metformin
• Breast Cancer

Interventions

Type	Name	Description
DRUG	Metformin

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2021-09-23
• Last updated: 2021-09-23