Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT01302002
Status:
WITHDRAWN
Last Update Posted:
2016-02-23
First Post:
2011-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Use of Metformin in Early Breast Cancer Patients Pre-Surgery
Sponsor:
Instituto Nacional de Cancer, Brazil
Organization:
Study Overview
Official Title:
The Use of Metformin in Early Breast Cancer Patients Pre-Surgery: A Phase 0 Study Regarding The Biological Effect
Status:
WITHDRAWN
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
The study will collect and analyze pre- and post-treatment blood specimens for:
* Serum glucose
* Insulin levels
* Estradiol
* HOMA test
* Glycosylated haemoglobin
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: