Neoadjuvant Chemotherapy With or Without Metformin in Early Breast Cancer.

  • STATUS
    Recruiting
  • participants needed
    120
  • sponsor
    Mansoura University
Updated on 19 February 2024
cancer
breast cancer
metastasis
breast carcinoma
carcinoma
metformin
preoperative chemotherapy

Summary

Metformin is a widely used anti-diabetic drug. Several studies have pointed out a potentially beneficial effect of metformin therapy in diabetic cancer patients. Several studies are investigating the anti-tumor effect of metformin in early breast cancer. However, the enhancing effect of metformin on anti-tumor immunity has only been demonstrated in animal models. This study examines the immune effect of metformin in breast cancer patients treated with preoperative chemotherapy.

Details
Condition Breast Cancer, Breast Cancer
Age 18years - 65years
Treatment Placebo Oral Tablet, Metformin
Clinical Study IdentifierNCT04387630
SponsorMansoura University
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically proven breast carcinoma
American Society of Anesthesiology (ASA) score I-II
Candidate for neoadjuvant chemotherapy as per hospital's protocol
Clinically measurable tumor
No evidence of distant metastasis
Normal renal and liver functions
Non-diabetics

Exclusion Criteria

Pregnant or lactating women
Metastatic breast cancer patients
Patients with hepatic impairment
Patients with renal impairment
Diabetics
Patients unwilling to participate or withdrawing from the trial
Psychological/ mental impairment
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