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

NCT05053841 | Completed Phase 2

• 1 other identifier: 22014
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Metformin; Breast Cancer

Outcome Measures

Primary Outcomes (1)

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

  measuring the serum levels of the studied biomarkers

  six months

Study Arms (3)

Control group

NO INTERVENTION

fifteen obese females who received letrozole only

metformin group

ACTIVE COMPARATOR

fifteen obese females who received the same dose of letrozole plus metformin (2000 ± 500) mg daily

Drug: Metformin

lean group

NO INTERVENTION

fifteen non- obese breast cancer females who received letozole for six months, treatment period

Interventions

Metformin DRUG

Also known as: Glucophage

metformin group

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Related Publications (1)

• El-Attar AA, Ibrahim OM, Alhassanin SA, Essa ES, Mostafa TM. Effect of metformin as an adjuvant therapy to letrozole on estradiol and other biomarkers involved in the pathogenesis of breast cancer in overweight and obese postmenopausal women: a pilot study. Eur J Clin Pharmacol. 2023 Feb;79(2):299-309. doi: 10.1007/s00228-022-03444-6. Epub 2022 Dec 23.

  PMID: 36562831 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Metformin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Aya Ahmed El Attar

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 23, 2021
• Study Start: February 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 23, 2021

Record last verified: 2021-08