Clinical trial · Interventional
Pre-Surgical Trial of the Combination of Metformin and Atorvastatin in Newly Diagnosed Operable Breast Cancer
Pre-Surgical "Window of Opportunity" Trial of the Combination of Metformin and Atorvastatin in Newly Diagnosed Operable Breast Cancer
- 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 purpose of this study is to determine the effects of combining metformin and atorvastatin treatment in patients with newly diagnosed breast cancer during the interval between breast biopsy and surgery. This study is designed to assess whether tumor proliferation, as measured by the natural log expression of Ki-67 staining of breast tumor cells, is reduced following approximately 2 weeks of treatment with the combination of metformin plus atorvastatin in patients with newly diagnosed breast cancer.
Conditions
Conditions (3)
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 |
| Cancer of Breast | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atorvastatin | Drug | — | UNRESOLVED |
| Breast surgery | Procedure | — | UNRESOLVED |
| Metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Metformin-Atorvastatin combination
- description
- Patients will receive metformin and atorvastatin for approximately 2 weeks prior to breast surgery.
- interventionNames
- Drug: Metformin
- Drug: Atorvastatin
- Procedure: Breast surgery
Primary outcomes (1)
- measure
- Change in tissue levels of the proliferation marker Ki-67
- timeFrame
- Baseline, 2 weeks after start of treatment
- description
- Tumor proliferation, as measured by the natural log expression of Ki-67 staining of breast tumor cells.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Female subjects with histologically-confirmed operable invasive breast cancer or DCIS, who undergo core needle biopsy followed by surgical excision at least 2 weeks after enrollment * ≥ 5 mm by imaging/pathology of core to ensure enough pre- and post-treatment tissue for analysis * Age ≥ 21 years. Breast cancer is uncommon in patients less than this age. * No prior chemotherapy, radiation therapy, or breast resection within 6 months of study entry * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 * Signed informed consent Exclusion Criteria: * Currently on medication for diabetes or hypercholesterolemia * Treatment with other investigational drugs within 6 months of study entry * Strong Cytochrome P450 3A4 (abbreviated CYP3A4) (e.g., clarithromycin, HIV protease inhibitors, and itraconazole), given potential interactions with atorvastatin * Renal impairment with a creatinine \> 1.4 mg/dl * Hepatic impairment: Aspartate transaminase (AST)/(SGOT), Alanine Transaminase(ALT)/(SGPT) ≥ 2.5 x upper limit of normal range (ULN), OR Total bilirubin ≥ 1.5 x ULN (subjects with Gilbert's syndrome can have bilirubin of up to 1.5 x ULN), OR Alkaline phosphatase \> 2.5 x ULN
References
Publications (0)
Data not yet available