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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Instituto Nacional de Cancer, Brazil.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Instituto Nacional de Cancer, Brazil
ClinicalTrials.gov Identifier:
NCT01302002
First received: February 14, 2011
Last updated: February 22, 2011
Last verified: February 2011
  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
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]
    • 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 ] [ Designated as safety issue: No ]
    -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


Estimated Enrollment: 30
Study Start Date: January 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: September 2011 (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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01302002

Contacts
Contact: Ana Elisa Lohmann, MD 55-21-38796110 anaelisalohmann@gmail.com

Locations
Brazil
Hospital do Cancer III Recruiting
Rio de Janeiro, Brazil, 20560-120
Contact: Ana Elisa Lohmann, MD    55-21-3879-6110    anaelisalohmann@gmail.com   
Contact: Manuela Vasques Cardoso, RN    55-21-3879-6110    mvasques@inca.gov.br   
Principal Investigator: Ana Elisa Lohmann, MD         
Sub-Investigator: Jose Bines, MD         
Sub-Investigator: Martin Bonamino         
Sub-Investigator: Cinthya Sternberg         
Sponsors and Collaborators
Instituto Nacional de Cancer, Brazil
Investigators
Principal Investigator: Ana Elisa Lohmann, MD Instituto Nacional de Cancer
  More Information

No publications provided

Responsible Party: Ana Elisa Lohmann, Instituto Nacional de Cancer
ClinicalTrials.gov Identifier: NCT01302002     History of Changes
Other Study ID Numbers: INCA113/10
Study First Received: February 14, 2011
Last Updated: February 22, 2011
Health Authority: Brazil: Ministry of Health

Keywords provided by 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
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014