Clinical trial · Interventional
Role of Adding Metformin to Neoadjuvant Chemotherapy in Patients With Breast Cancer (METNEO)
Investigation of the Potential Beneficial Effect of Adding Metformin to Neoadjuvant Chemotherapy in Patients With Breast Cancer (METNEO)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AC-T chemotherapy regimen | Drug | — | UNRESOLVED |
| Metformin Hydrochloride 850 mg Tablets | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Metformin group
- description
- Patients will receive AC-T neoadjuvant chemotherapy in addition to oral metformin HCl (850 mg tablets, twice per day, for 6 months) (n= 30)
- interventionNames
- Drug: Metformin Hydrochloride 850 mg Tablets
- Drug: AC-T chemotherapy regimen
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- Patients will receive AC-T neoadjuvant chemotherapy alone (n= 30)
- interventionNames
- Drug: AC-T chemotherapy regimen
Primary outcomes (2)
- measure
- Evaluation of the effect on tumor apoptosis
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDSerageldin MA, El-Bassiouny NA, El-Kerm Y, Aly RG, Helmy MW, El-Mas MM, Kassem AB. A randomized controlled study of neoadjuvant metformin with chemotherapy in nondiabetic breast cancer women: The METNEO study. Br J Clin Pharmacol. 2024 Dec;90(12):3160-3175. doi: 10.1111/bcp.16193. Epub 2024 Aug 7. PMID 39113190
- DERIVEDSerageldin MA, Kassem AB, El-Kerm Y, Helmy MW, El-Mas MM, El-Bassiouny NA. The Effect of Metformin on Chemotherapy-Induced Toxicities in Non-diabetic Breast Cancer Patients: A Randomised Controlled Study. Drug Saf. 2023 Jun;46(6):587-599. doi: 10.1007/s40264-023-01305-4. Epub 2023 May 2. PMID 37131014