Neoadjuvant Chemotherapy With or Without Metformin in Early Breast Cancer.

Mansoura University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Placebo oral tablet; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT04387630

R.20.05.834

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups, including a placebo group

metformin group

Experimental group

Description:

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.

Treatment:

Drug: Metformin

Placebo group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo oral tablet