Clinical trial · Interventional
The Effect of Metformin on Breast Cancer Patients
NCT04559308CI-TRIAL-00047266unknownPhase 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)
Several clinical trials have addressed the promising anticancer effect of metformin on the survival benefits, clinical response, and pathological response of breast cancer patients. Therefore, this study will assess the anticancer effect of metformin when added to the neoadjuvant chemotherapy protocol of non-diabetic breast cancer patients. In addition to, the impact of metformin addition to the neoadjuvant chemotherapy on the quality of life of breast cancer 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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- metformin arm
- description
- 4 cycles (Doxorubicin+Cyclophosphamide) followed by 12 cycles Paclitaxel+ Metformin (1000 mg twice daily) followed by surgery.
- interventionNames
- Drug: Metformin
- Drug: Chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- control arm
- description
- 4 cycles (Doxorubicin+Cyclophosphamide) followed by 12 cycles Paclitaxel followed by surgery.
- interventionNames
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- Clinical benefit rate (Tumor size)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Non-diabetic breast cancer patients, receiving neoadjuvant chemotherapy treatment. 2. Female Age between 18- 65 years. 3. Written informed consent. Exclusion Criteria: 1. Known hypersensitivity reaction to Metformin. 2. Intolerable Metformin GI complaints. 3. Patients at risk of lactic acidosis. 4. Diabetic breast cancer patients. 5. Body Mass Index \< 18.5 (underweight breast cancer patients). 6. Renal impairment, eGFR \<45 mL/min/1.73 m².
References
Publications (0)
Data not yet available
No reference posted for this study.