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

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ClinicalTrials.gov Identifier: NCT00984490
Recruitment Status : Terminated (slow accrual)
First Posted : September 25, 2009
Results First Posted : July 13, 2012
Last Update Posted : July 13, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ingrid Mayer, MD, Vanderbilt-Ingram Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: metformin hydrochloride
Other: laboratory biomarker analysis
Enrollment 5
Recruitment Details This study recruited patients from September 24, 2009 through June 28, 2011.
Pre-assignment Details Five patients enrolled on this study during the first nine months. Accrual continued to be slow causing its premature closing.
Arm/Group Title Metformin
Hide Arm/Group Description Metformin: 850 mg PO twice a day for 7-21 days (discontinued 24-36 hrs prior to surgery
Period Title: Overall Study
Started 5
Completed 5
Not Completed 0
Arm/Group Title Metformin
Hide Arm/Group Description Metformin: 850 mg PO twice a day for 7-21 days (discontinued 24-36 hrs prior to surgery
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
45  (1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
5
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title Change in Ki67 Levels Before and After Treatment
Hide Description Change in Ki67 levels in pre-treatment, pre-surgery and post-treatment, surgically excised breast tissue. Measured by percentage of positive-staining nuclei with a minimum of 0% to a maximum of 100%. A mean score is determined.
Time Frame baseline and between 8-23 days
Hide Outcome Measure Data
Hide Analysis Population Description
No Ki67 levels were determined. This clinical trial was closed due to slow accrual
Arm/Group Title Metformin
Hide Arm/Group Description:
Metformin: 850 mg orally (PO) twice a day for 7-21 days, discontinued 24-36 hrs prior to surgery
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Changes in Circulating Insulin-like Growth Factor 1 (IGF-1) and IGF Binding Protein 3 (IGFBP-3)
Hide Description Effect of study drug on circulating IGF-1 and IGFBP-3 as measured in ng/mL in peripheral blood samples taken pre-treatment and post-treatment with metformin
Time Frame baseline and 23 days
Hide Outcome Measure Data
Hide Analysis Population Description
No levels of IGF-1 and IGFBP-3 were determined. This clinical trial was closed due to slow accrual.
Arm/Group Title Metformin
Hide Arm/Group Description:
Metformin: 850 mg PO twice a day for 7-21 days (discontinued 24-36 hrs prior to surgery)
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Metformin
Hide Arm/Group Description Metformin: 850 mg PO twice a day for 7-21 days (discontinued 24-36 hrs prior to surgery
All-Cause Mortality
Metformin
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Metformin
Affected / at Risk (%) # Events
Total   0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Metformin
Affected / at Risk (%) # Events
Total   4/5 (80.00%)    
Gastrointestinal disorders   
diarrhea  4/5 (80.00%)  5
nausea  2/5 (40.00%)  2
Injury, poisoning and procedural complications   
vomiting  1/5 (20.00%)  1
Investigations   
weight loss  1/5 (20.00%)  1
Because this study was closed prematurely, no assay level markers or pathways were performed consequently no data are available to provide results.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Ingrid Mayer, MD
Organization: Vanderbilt-Ingram Cancer Center
Phone: 615-936-2033
Responsible Party: Ingrid Mayer, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00984490     History of Changes
Other Study ID Numbers: VICC BRE 0942
P30CA068485 ( U.S. NIH Grant/Contract )
VU-VICC-BRE-0942
First Submitted: September 24, 2009
First Posted: September 25, 2009
Results First Submitted: March 12, 2012
Results First Posted: July 13, 2012
Last Update Posted: July 13, 2012