Neoadjuvant Chemotherapy With or Without Metformin in Early Breast Cancer.

Breast Cancer Clinical Trial

Official title:

Neoadjuvant Chemotherapy With or Without Metformin in Early Breast Cancer.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04387630
• Other study ID #: R.20.05.834
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: June 5, 2020
• Est. completion date: May 1, 2023

Study information

• Verified date: June 2020
• Source: Mansoura University
• Contact: Osama Hussein
• Phone: 0020 1099 8151 10
• Email: osama.hussein[@]mail.mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 1, 2023
• Est. primary completion date: June 5, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Metformin
Oral hypoglycemic drug. Initial dose 500-850 mg/d. incrementally increased to a maximum daily dose of 2550 mg in three divided doses.
• Placebo oral tablet
Simethicone 60 mg three times daily.

Locations

Country	Name	City	State
Egypt	Mansoura University Cancer center	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Coyle C, Cafferty FH, Vale C, Langley RE. Metformin as an adjuvant treatment for cancer: a systematic review and meta-analysis. Ann Oncol. 2016 Dec;27(12):2184-2195. doi: 10.1093/annonc/mdw410. Epub 2016 Sep 28. Review. — View Citation

Eikawa S, Nishida M, Mizukami S, Yamazaki C, Nakayama E, Udono H. Immune-mediated antitumor effect by type 2 diabetes drug, metformin. Proc Natl Acad Sci U S A. 2015 Feb 10;112(6):1809-14. doi: 10.1073/pnas.1417636112. Epub 2015 Jan 26. — View Citation

Pearce EL, Walsh MC, Cejas PJ, Harms GM, Shen H, Wang LS, Jones RG, Choi Y. Enhancing CD8 T-cell memory by modulating fatty acid metabolism. Nature. 2009 Jul 2;460(7251):103-7. doi: 10.1038/nature08097. Epub 2009 Jun 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	T-cell cytotoxic markers.	Percentage of cells staining positive per high power field for the T-cell cytotoxic markers (Granzyme-B, Perforin & CD-8) using immunohistochemistry (IHC).	procedure
Primary	Clinical Response rate	Response to preoperative therapy as per ultrasonographic tumor size assessment. A responder will have > 50% decrease in the size of the primary tumor without appearance of new lesions.	at three months from starting therapy.