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The Use of Metformin in Early Breast Cancer Patients Pre-Surgery: A Phase 0 Study Regarding The Biological Effect


Phase 0
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

The Use of Metformin in Early Breast Cancer Patients Pre-Surgery: A Phase 0 Study Regarding The Biological Effect


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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

To determine the in situ effects of metformin in women with operable stage I or II breast cancer

Outcome Description:

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(+).

Outcome Time Frame:

60 days after the surgery

Safety Issue:

No

Principal Investigator

Ana Elisa Lohmann, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Instituto Nacional de Cancer

Authority:

Brazil: Ministry of Health

Study ID:

INCA113/10

NCT ID:

NCT01302002

Start Date:

January 2011

Completion Date:

December 2011

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Metformin
  • Pre-Surgery
  • Breast Neoplasms

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