NCT00984490

Metformin Hydrochloride in Treating Women With Stage I or Stage II Breast Cancer That Can Be Removed By Surgery

Pre-Surgical Trial of Metformin in Patients With Operable Breast Cancer

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Metformin hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying how well metformin hydrochloride works in treating women with stage I or stage II breast cancer that can be removed by surgery.

Detailed description

OBJECTIVES: Primary * To determine the in situ effects of metformin hydrochloride on proliferation (Ki67) and apoptosis (caspase-3) in women with operable stage I or II breast cancer. Secondary * To determine the in situ biologic effect of metformin hydrochloride on the AMP kinase, MTOR/PI3K, and IGF pathways in breast cancer (tissue S6K and phospho S6K, p53, p63, and p73 levels as well as p53 \[(Ser-15), if wild-type p53 is present\], p63 \[Ser-66/68, Ser-301, and Ser-361\], and p73 \[Y-99\] phosphorylation, PTEN \[clone 6H2.1\], phospho-Akt \[S473\], insulin receptor substrate 1 and 2 \[IRS-1 and IRS-2\], and LKB1). * To determine if molecular classification (basal-type vs luminal A vs luminal B) and the established p63 and p73 RNA microarray gene signatures correlate with the metformin hydrochloride-induced effects on proliferation (Ki67), apoptosis (caspase-3) and the selected biomarkers (listed above) in breast cancer. * To collect and analyze pre- and post-treatment peripheral blood specimens for serum glucose and insulin levels, as well as circulating IGF-1 and IGF binding protein 3 (IGFBP3). OUTLINE: Patients receive oral metformin hydrochloride twice daily for 7-21 days. Approximately 24-36 hours after the last dose of metformin hydrochloride, patients undergo surgical resection (total mastectomy or segmental resection with lymph node evaluation) of tumor. Patients undergo blood and tissue sample collection periodically for biomarker analysis.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	metformin hydrochloride	Metformin: 850 mg orally (PO) twice daily (BID) for 7-21 days, discontinued 24-36 hrs prior to surgery
OTHER	laboratory biomarker analysis	Blood and tissue collection to determine the in situ biologic effect of metformin

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-07-01
• Completion: 2011-07-01
• First posted: 2009-09-25
• Last updated: 2024-02-01
• Results posted: 2012-07-13

Locations

3 sites across 1 country: United States