Trials / Withdrawn
WithdrawnNCT01302002
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
- Status
- Withdrawn
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Instituto Nacional de Cancer, Brazil · Other Government
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study will test metformin in patients with early breast cancer. Blood and tissue will be collected before and after the use of metformin.
Detailed description
Patients will take metformin twice a day for 3 weeks before surgery. The hypothesis is that metformin will reduce cell proliferation rates (Ki67) and increase apoptoses (TUNEL)in tumor tissue. The study will collect and analyze pre- and post-treatment blood specimens for: * Serum glucose * Insulin levels * Estradiol * HOMA test * Glycosylated haemoglobin
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Metformin Pre-Surgery | 500 mg tablet, taken twice a day for 3 weeks |
Timeline
- Start date
- 2011-01-01
- Primary completion
- 2016-02-01
- Completion
- 2016-02-01
- First posted
- 2011-02-23
- Last updated
- 2016-02-23
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT01302002. Inclusion in this directory is not an endorsement.