Phase 2
Completed N=35
Pre-Surgical Study: Effect of Metformin on Breast Cancer Proliferation
Source: ClinicalTrials.gov NCT00930579 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcomePrimary: Tumor Proliferation in Tumor Specimens — 2.17; 2.165 percentage of ki-67 positive cells — p=0.98
Summary
The purpose of this pilot study is to use a pre surgical intervention model to evaluate the biologic effects of metformin in women with newly diagnosed early invasive breast cancer. Metformin is a drug commonly used to treat patients with diabetes. This model will be used to evaluate the effects of metformin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tumor Proliferation in Tumor Specimens |
2.17; 2.165 | 0.98 |
Eligibility Criteria
Inclusion Criteria
- Histologically-confirmed operable invasive breast cancer or ductal carcinoma in situ (DCIS) who undergo core needle biopsy followed by surgical excision at least 2 weeks after enrollment
- Body mass index > 25
- Age ≥ 21 years
- No prior chemotherapy, radiation therapy, or surgery within 6 months of study entry
- Signed informed consent
Exclusion Criteria
- History of diabetes mellitus requiring medical therapy
- Treatment with other investigational drugs within 6 months of study entry
- Significant renal impairment with a creatinine > 1.4 mg/dl
- Other serious intercurrent medical illness
Data sourced from ClinicalTrials.gov (NCT00930579). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.