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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Anti-tumor Effect of Metformin And Atorvastatin in Breast Cancer

NCT05507398

Breast Cancer Female

UNKNOWN PHASE4

Effect of Metformin on Endometrial Thickness in Postmenopausal Breast Cancer Patients Receiving Tamoxifen

NCT07145827

Breast Cancer Endometrial Hyperplasia and Endometrial Cancers

COMPLETED NA

Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk

NCT06557057

HER2-Positive Breast Carcinoma

RECRUITING

Adjuvant Ovarian Suppression Plus Aromatase Inhibitor or Tamoxifen in Young Women

NCT02914158

Breast Cancer

RECRUITING PHASE3

Neoadjuvant Hormonal Therapy Compared to Neoadjuvant Chemotherapy in Stage IIIB/C and IV Breast Cancer Patients

NCT02995772

Breast Cancer

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Metformin Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

fifteen obese females who received letrozole only

Group Type NO_INTERVENTION

No interventions assigned to this group

metformin group

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

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

lean group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Metformin

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Glucophage

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No