Clinical trial · Interventional
The Use of Metformin in Early Breast Cancer Patients Pre-Surgery
The Use of Metformin in Early Breast Cancer Patients Pre-Surgery: A Phase 0 Study Regarding The Biological Effect
NCT01302002CI-TRIAL-00021037withdrawnEarly Phase 1ClinicalTrials.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)
The study will test metformin in patients with early breast cancer. Blood and tissue will be collected before and after the use of metformin.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin Pre-Surgery | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Metformin Pre-Surgery
- description
- Patients will take metformin twice a day for three weeks prior surgery
- interventionNames
- Drug: Metformin Pre-Surgery
Primary outcomes (1)
- measure
- To determine the in situ effects of metformin in women with operable stage I or II breast cancer
- timeFrame
- 60 days after the surgery
- description
- To determine the in situ effects of metformin on * proliferation (Ki67) and apoptosis (TUNEL), fosforilate AKT * CD1a CD83, CD68, F40/80, arginase iNOS and T cells -CD4(+),CD45RA(+), CD 45RO, CD4, CD8 and FOXP3(+).
Secondary outcomes (2)
- measure
- To analyse gastrointestinal toxicity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Invasive breast cancer T1 or T2, Nx * Knowledge of the investigational nature of the study and ability to provide consent for study participation Exclusion Criteria: * Diabetes or baseline glucose or Glycosylated haemoglobin upper limit of normal for the institution * Recent use of corticosteroids * AST \> 1.5 times upper limit of normal for the institution * Pregnancy * Serious clinical illness * Prior or concurrent systemic neoadjuvant Breast Cancer therapy.
References
Publications (0)
Data not yet available
No reference posted for this study.