Role of Adding Metformin to Neoadjuvant Chemotherapy in Patients With Breast Cancer (METNEO)

• Status: Unknown status
• Trial end date: 2020-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

Metformin, the widely prescribed oral hypoglycemic drug, is well known for its established efficacy, favorable safety profile, and low cost. Metformin has recently received increasing attention because of its potential antitumorigenic effects that are thought to be independent of its hypoglycemic effects. It has been extensively studied in preclinical models, which have implicated several molecular pathways in its antitumor activity.

Metformin was proved to have anti-proliferative and apoptotic effects on tumor cells.Moreover, metformin enhances the T-cell mediated immune response to tumor tissue and fights metastases. Also, epidemiological studies have shown that metformin, but not other antidiabetic drugs, reduces cancer incidence and improves survivability in diabetic cancer patients.

The proposed research in this application will investigate two prime questions with regards to the combined use of metformin together with traditional neoadjuvant chemotherapy in breast cancer patients. First, the hypothesis that the simultaneous use of metformin along with doxorubicin/cyclophosphamide/paclitaxel neoadjuvant protocol produces better antitumor outcomes will be tested. Second, the study will examine if the improved apoptotic effect of such regimen is paralleled by exaggerated stimulatory influences on apoptosis biomarkers.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Damanhour University
• Collaborator: Alexandria University
• Treatments: Cyclophosphamide; Doxorubicin; Metformin; Paclitaxel

Criteria

Inclusion Criteria:

1. Females ≥ 18 years of age and < 65 years.

2. Unilateral or bilateral primary carcinoma of the breast confirmed.

3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2.

4. Clinically measurable tumor size who are candidates for neoadjuvant therapy.

5. No evidence of distant metastasis.

6. Normal renal and liver functions.

7. Non-diabetics.

Exclusion Criteria:

1. Pregnant or breastfeeding women.

2. Prior cancer chemotherapy.

3. Heart disease or reduced cardiac output with left ventricular ejection fraction < 50%.

4. Metastatic breast cancer patients.

5. Patients with hepatic impairment.

6. Patients with renal impairment.

7. Diabetics.