Evaluation of the Effect of Metformin on Metastatic Breast Cancer as Adjuvant Treatment

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

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-20

Study Completion Date

2020-06-30

Brief Summary

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

This study aims to determine the effect of metformin along with standard cancer treatment, and its effect on the prognosis of the metastatic breast in non-diabetic patients.

Related Clinical Trials

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

Metformin for the Treatment of Insulin Resistance in Women With Stage I-III Breast Cancer Completing Chemotherapy

NCT06763328

Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 +1 more

RECRUITING PHASE3

Metformin Plus Neoadjuvant Chemotherapy in Breast Cancer

NCT01566799

Locally Advanced Malignant Neoplasm

UNKNOWN PHASE2

Randomized Trial of Neo-adjuvant Chemotherapy With or Without Metformin for HER2 Positive Operable Breast Cancer

NCT03238495

HER2-positive Breast Cancer

UNKNOWN PHASE2

Metformin and Nightly Fasting in Women With Early Breast Cancer

NCT05023967

Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Breast Ductal Carcinoma In Situ +1 more

ACTIVE_NOT_RECRUITING PHASE2

Study to Evaluate the Effect of Metformin in the Prevention of HG in HR[+]/HER2[-] PIK3CA-mut Advanced BC Patients

NCT04300790

Breast Cancer

COMPLETED PHASE2

Detailed Description

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

the role of metformin when combined with traditional metastatic breast cancer treatment in non-diabetic patients compared to diabetic patients who are not using metformin. In this randomized control study, there will be a demonstration either it is effective to suppress tumor burden or not through normal screening for tumor.

Conditions

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

Metastatic 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

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Metformin group

Non Diabetic metastatic breast cancer Patients will take metformin 1 gm. twice daily (Nathan 2009) along with standard chemotherapy

Group Type EXPERIMENTAL

Metformin plus chemotherapy

Intervention Type DRUG

determine the effect of metformin along with standard chemotherapy

control group

Non Diabetic metastatic breast cancer Patients will take standard chemotherapy only

Group Type OTHER

Chemotherapy

Intervention Type DRUG

standard chemotherapy

Interventions

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

Metformin plus chemotherapy

determine the effect of metformin along with standard chemotherapy

Intervention Type DRUG

Chemotherapy

standard chemotherapy

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* The non-diabetic patients will be included in the study if they meet the following criteria:

1. Confirmed metastatic breast cancer (IV stage) radiologically or by clinical evaluation receiving chemotherapy
2. Age between 18- 70 years.
3. Life expectancy at least 6 months

Exclusion Criteria

* The patients will be excluded from the study if they have the following criteria:

1. Bad prognosis disease: Criteria defined as the following

* If patient \>70 years
* If patient has bad site metastasis (brain)
2. Hypersensitivity for metformin: if happened patient will be treated as following

• Pheniramine Maleate 3 times daily for 7 days and Tablet Dexamethasone 1mg daily in 2 divided doses for 5 days \[16\].
3. Any condition associated with increased risk of metformin-associated lactic acidosis (e.g., congestive heart failure defined as New York Heart Association {NYHA} Class III or IV functional status; the history of acidosis of any type, severe infections, kidney or liver disease, respiratory disease, seizures .
4. Diabetic patients.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No