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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01302002
• Other study ID #: INCA113/10
• Status: Withdrawn
• Phase: Phase 0
• First received: February 14, 2011
• Last updated: February 22, 2016
• Start date: January 2011
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Instituto Nacional de Cancer, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The study will test metformin in patients with early breast cancer. Blood and tissue will be collected before and after the use of metformin.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Metformin Pre-Surgery
500 mg tablet, taken twice a day for 3 weeks

Locations

Country	Name	City	State
Brazil	Hospital do Cancer III	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Cancer, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the in situ effects of metformin in women with operable stage I or II breast cancer	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(+).	60 days after the surgery	No
Secondary	To analyse gastrointestinal toxicity	To analyse gastrointestinal toxicity grade (examples: nausea, stomach pain, vomiting); Number of Participants with Adverse Events	One week , 2 weeks and 20 days after Metformim beginning	Yes
Secondary	To analyse the blood tests one day before the biopsy and one day before the surgery	-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	5 days after blood collection	No