Clinical trial · Interventional
Evaluation of the Effect of Metformin on Metastatic Breast Cancer as Adjuvant Treatment
NCT04143282CI-TRIAL-00055410completedPhase 2ClinicalTrials.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 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.
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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Metformin plus chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Metformin group
- description
- Non Diabetic metastatic breast cancer Patients will take metformin 1 gm. twice daily (Nathan 2009) along with standard chemotherapy
- interventionNames
- Drug: Metformin plus chemotherapy
- type
- OTHER
- label
- control group
- description
- Non Diabetic metastatic breast cancer Patients will take standard chemotherapy only
- interventionNames
- Drug: Chemotherapy
Primary outcomes (3)
- measure
- The radiologic response rate
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.References
Publications (1)
- DERIVEDSalah H, Rabea H, Sheemy MS, Rabie AI, Moustafa HAM, Elberry AA, Hassan A. Targeting insulin-like growth factor-1 (IGF-1) by using metformin in non-diabetic metastatic breast cancer female patients: a randomized controlled trial. Cancer Chemother Pharmacol. 2025 Jun 28;95(1):64. doi: 10.1007/s00280-025-04791-8. PMID 40579605