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

This study has been terminated.
(slow accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ingrid Mayer, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00984490
First received: September 24, 2009
Last updated: June 7, 2012
Last verified: June 2012
Results First Received: March 12, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: metformin hydrochloride
Other: laboratory biomarker analysis

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study recruited patients from September 24, 2009 through June 28, 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Five patients enrolled on this study during the first nine months. Accrual continued to be slow causing its premature closing.

Reporting Groups
  Description
Metformin Metformin: 850 mg PO twice a day for 7-21 days (discontinued 24-36 hrs prior to surgery

Participant Flow:   Overall Study
    Metformin  
STARTED     5  
COMPLETED     5  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Metformin Metformin: 850 mg PO twice a day for 7-21 days (discontinued 24-36 hrs prior to surgery

Baseline Measures
    Metformin  
Number of Participants  
[units: participants]
  5  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     5  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  45  ± 1  
Gender  
[units: participants]
 
Female     5  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     5  



  Outcome Measures
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1.  Primary:   Change in Ki67 Levels Before and After Treatment   [ Time Frame: baseline and between 8-23 days ]

2.  Secondary:   Changes in Circulating Insulin-like Growth Factor 1 (IGF-1) and IGF Binding Protein 3 (IGFBP-3)   [ Time Frame: baseline and 23 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Because this study was closed prematurely, no assay level markers or pathways were performed consequently no data are available to provide results.


  More Information
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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
e-mail: ingrid.mayer@vanderbilt.edu


No publications provided


Responsible Party: Ingrid Mayer, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00984490     History of Changes
Other Study ID Numbers: VICC BRE 0942, P30CA068485, VU-VICC-BRE-0942
Study First Received: September 24, 2009
Results First Received: March 12, 2012
Last Updated: June 7, 2012
Health Authority: United States: Food and Drug Administration