Clinical trial · Interventional
Use of Metformin to Reduce Cardiac Toxicity in Breast Cancer
A Phase II Pilot Study Using Metformin to Reduce Cardiac Toxicity in Breast Cancer Patients
NCT02472353CI-TRIAL-00041166terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): did not meet target accrual
Summary
Brief summary (as posted)
The goal of this study is to determine if co-administration of metformin and doxorubicin in breast cancer patients receiving neoadjuvant or adjuvant therapy will reduce the number of patients who develop a significant change in left ventricle ejection fraction (LVEF).
Conditions
Conditions (2)
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 |
| Breast Tumors | Breast Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard of Care
- description
- Patients will receive standard of care for their breast cancer with no metformin during their treatment with doxorubicin.
- interventionNames
- Drug: Doxorubicin
- type
- EXPERIMENTAL
- label
- Metformin + Standard of Care
- description
- Patients will receive metformin during their treatment with doxorubicin for their breast cancer.
- interventionNames
- Drug: Metformin
- Drug: Doxorubicin
Primary outcomes (1)
- measure
- Number of Participants With Less Than or Equal to 5% Decrease in Left Ventricle Ejection Fraction (LVEF) on Echocardiogram
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Breast cancer requiring neoadjuvant or adjuvant therapy with doxorubicin * Complete metabolic panel demonstrating adequate organ functions as defined by the following: Aspartate transaminase (AST) less than 2.5 times Upper Limit of Normal (ULN); Alanine transaminase (ALT) less than 2.5 times ULN; alkaline phosphatase less than 2.5 times ULN; serum creatinine less than 1.5 mg/dL; serum bilirubin less than ULN * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Age greater than or equal to 21 years Exclusion Criteria: * Known diabetes * History of cardiac arrhythmias or symptomatic cardiac disease * Currently taking antiarrhythmic medications, beta-blockers, or other rate controlling cardiac medications * Currently taking metformin and/or sulfonylureas * Known hypersensitivity or intolerance to metformin * Baseline ejection fraction of less than 50% measured by echocardiogram * Known hypersensitivity to contrast used during echocardiogram * Risk factors associated with increased risk of metformin-associated lactic acidosis (e.g. congestive heard failure, history of acidosis, habitual intake of 3 or more alcoholic beverages per day) * Pregnant or breast feeding
References
Publications (1)
- DERIVEDSun ML, Dong JM, Liu C, Li P, Zhang C, Zhen J, Chen W. Metformin-mediated protection against doxorubicin-induced cardiotoxicity. Biomed Pharmacother. 2024 Nov;180:117535. doi: 10.1016/j.biopha.2024.117535. Epub 2024 Oct 15. PMID 39405911