Neoadjuvant Chemotherapy With or Without Metformin in Early Breast Cancer.

Study Overview
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Brief Summary
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Metformin is a widely used anti-diabetic drug. Several studies have pointed out a potentially beneficial effect of metformin therapy in diabetic cancer patients. Several studies are investigating the anti-tumor effect of metformin in early breast cancer. However, the enhancing effect of metformin on anti-tumor immunity has only been demonstrated in animal models. This study examines the immune effect of metformin in breast cancer patients treated with preoperative chemotherapy.

Official Title
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Neoadjuvant Chemotherapy With or Without Metformin in Early Breast Cancer.

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Metformin
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven breast carcinoma. American Society of Anesthesiology (ASA) score I-II. Candidate for neoadjuvant chemotherapy as per hospital's protocol. Clinically measurable tumor. No evidence of distant metastasis. Normal renal and liver functions. Non-diabetics. Exclusion Criteria: Pregnant or lactating women. Metastatic breast cancer patients. Patients with hepatic impairment. Patients with renal impairment. Diabetics. Patients unwilling to participate or withdrawing from the trial. Psychological/ mental impairment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: metformin group<br>metformin 850 mg once daily increased within 3 weeks to a maximum dose of 2550 mg on three divided daily doses. Neoadjuvant cytotoxic chemotherapy as per MDT (multi-disciplinary team) decision. Patients scheduled for AC-T (adriamycin, Cyclophosphamide, paclitaxel) or AC (adriamycin, cyclophosphamide) will be eligible to randomization. | Drug: Metformin<br>* Oral hypoglycemic drug. Initial dose 500-850 mg/d. incrementally increased to a maximum daily dose of 2550 mg in three divided doses.<br>* Other names: Glucophage;|
| Placebo Comparator: Placebo group<br>placebo. Neoadjuvant cytotoxic chemotherapy as per MDT(multi-disciplinary team) decision. Patients scheduled for AC-T (adriamycin, Cyclophosphamide, paclitaxel) or AC (adriamycin, cyclophosphamide) will be eligible to randomization. | Drug: Placebo oral tablet<br>* Simethicone 60 mg three times daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Response rate | Response to preoperative therapy as per ultrasonographic tumor size assessment. A responder will have > 50% decrease in the size of the primary tumor without appearance of new lesions. | at three months from starting therapy. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, metformin, anti-tumor immunity