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The Use of Metformin in Early Breast Cancer Patients Pre-Surgery

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01302002
First Posted: February 23, 2011
Last Update Posted: February 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ana Elisa Lohmann, Instituto Nacional de Cancer, Brazil
  Purpose
The study will test metformin in patients with early breast cancer. Blood and tissue will be collected before and after the use of metformin.

Condition Intervention Phase
Breast Cancer Drug: Metformin Pre-Surgery Early Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Use of Metformin in Early Breast Cancer Patients Pre-Surgery: A Phase 0 Study Regarding The Biological Effect

Resource links provided by NLM:


Further study details as provided by Ana Elisa Lohmann, Instituto Nacional de Cancer, Brazil:

Primary Outcome Measures:
  • To determine the in situ effects of metformin in women with operable stage I or II breast cancer [ Time Frame: 60 days after the surgery ]

    To determine the in situ effects of metformin on

    • proliferation (Ki67) and apoptosis (TUNEL), fosforilate AKT
    • CD1a CD83, CD68, F40/80, arginase iNOS and T cells -CD4(+),CD45RA(+), CD 45RO, CD4, CD8 and FOXP3(+).


Secondary Outcome Measures:
  • To analyse gastrointestinal toxicity [ Time Frame: One week , 2 weeks and 20 days after Metformim beginning ]
    • To analyse gastrointestinal toxicity grade (examples: nausea, stomach pain, vomiting)
    • Number of Participants with Adverse Events

  • To analyse the blood tests one day before the biopsy and one day before the surgery [ Time Frame: 5 days after blood collection ]
    -To collect and analyze pre- and post-treatment peripheral blood specimens for serum glucose, glycosylated haemoglobin and insulin levels, as well as circulating IGF-1 and estradiol


Enrollment: 0
Study Start Date: January 2011
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metformin Pre-Surgery
Patients will take metformin twice a day for three weeks prior surgery
Drug: Metformin Pre-Surgery
500 mg tablet, taken twice a day for 3 weeks
Other Names:
  • Laboratory biomarker analysis
  • Blood and tissue collection

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Invasive breast cancer T1 or T2, Nx
  • Knowledge of the investigational nature of the study and ability to provide consent for study participation

Exclusion Criteria:

  • Diabetes or baseline glucose or Glycosylated haemoglobin upper limit of normal for the institution
  • Recent use of corticosteroids
  • AST > 1.5 times upper limit of normal for the institution
  • Pregnancy
  • Serious clinical illness
  • Prior or concurrent systemic neoadjuvant Breast Cancer therapy.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01302002


Locations
Brazil
Hospital do Cancer III
Rio de Janeiro, Brazil, 20560-120
Sponsors and Collaborators
Instituto Nacional de Cancer, Brazil
Investigators
Principal Investigator: Ana Elisa Lohmann, MD Instituto Nacional de Cancer
  More Information

Responsible Party: Ana Elisa Lohmann, Medical Oncologist, Instituto Nacional de Cancer, Brazil
ClinicalTrials.gov Identifier: NCT01302002     History of Changes
Other Study ID Numbers: INCA113/10
First Submitted: February 14, 2011
First Posted: February 23, 2011
Last Update Posted: February 23, 2016
Last Verified: February 2016

Keywords provided by Ana Elisa Lohmann, Instituto Nacional de Cancer, Brazil:
Breast Cancer
Metformin
Pre-Surgery

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs