Neoadjuvant Chemotherapy With or Without Metformin in Early Breast Cancer.

Phase 2

• Conditions: Breast Cancer
• Interventions: Drug: Placebo oral tablet; Drug: Metformin

• Registration Number: NCT04387630
• Lead Sponsor: Mansoura University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-11
• Study First Submitted QC: 2020-05-13
• Study First Posted: 2020-05-14
• Status Verified: 2020-06
• Study Start: 2020-06-05
• Last Update Submitted: 2020-06-08
• Last Update Posted: 2020-06-11
• Primary Completion: 2022-06-05
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo oral tablet	placebo. Neoadjuvant cytotoxic chemotherapy as per MDT(multi-disciplinary team) decision. Patients scheduled for AC-T (adriamycin, Cyclophosphamide, paclitaxel) or AC (adriamycin, cyclophosphamide) will be eligible to randomization.
metformin group	Metformin	metformin 850 mg once daily increased within 3 weeks to a maximum dose of 2550 mg on three divided daily doses. Neoadjuvant cytotoxic chemotherapy as per MDT (multi-disciplinary team) decision. Patients scheduled for AC-T (adriamycin, Cyclophosphamide, paclitaxel) or AC (adriamycin, cyclophosphamide) will be eligible to randomization.

Primary Outcome Measures

Name	Time	Method
Clinical Response rate	at three months from starting therapy.	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.

Trial Locations

Locations (1)

Mansoura University Cancer center; 🇪🇬 Mansoura, Egypt