Clinical trial · Interventional
The Anti-tumor Effect of Metformin And Atorvastatin in Breast Cancer
Comparative Clinical Study Evaluating the Anti-tumor Effect of Metformin Versus Atorvastatin as an Adjuvant Therapy With Chemotherapy in Patients With Non-metastatic Breast Cancer
NCT05507398CI-TRIAL-00061817unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study aims at evaluating and comparing the anti-tumor effects of metformin and statins (hydroxyl-methyl-glutaryl-CoA reductase inhibitors) in patients with non-metastatic breast cancer (stage I, II, \& III).
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo, metformin and atorvastatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- control group
- description
- 30 patients who will serve as a control group and will receive placebo tablets
- interventionNames
- Drug: Placebo, metformin and atorvastatin
- type
- ACTIVE_COMPARATOR
- label
- metformin group
- description
- 30 patients who will receive metformin 1000 mg/day.
- interventionNames
- Drug: Placebo, metformin and atorvastatin
- type
- ACTIVE_COMPARATOR
- label
- atorvastatin group
- description
- 30 patients who will receive atorvastatin 20 mg/day.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with radiologically and histologically (biopsy) confirmed diagnosis of breast cancer and with stage I, II, and stage III breast cancer according to the American Joint Committee on Cancer (TNM staging system of breast cancer). * Patients with no contraindication for chemotherapy, metformin, or statins * Females aged ≥ 18 years old * Performance status \< 2 according to the Eastern Cooperative Oncology Group (ECOG) score Exclusion Criteria: * Patients with metastatic breast cancer (stage IV) * Pregnant or lactating women. * Patients with hepatic or renal impairment. * Patients with myopathy. * Patients with any condition predispose to acidosis (COPD, heart failure, ….) * Patients who had dementia, mental retarded, and any psychiatric condition that would prohibit the understanding or signing of informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.