The Anti-tumor Effect of Metformin And Atorvastatin in Breast Cancer

Tanta University

Status and phase: Not yet enrolling; Phase 4

Conditions: Breast Cancer Female

Treatments: Drug: Placebo, metformin and atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT05507398

Breast cancer treatment

Details and patient eligibility

About

This study aims at evaluating and comparing the anti-tumor effects of metformin and statins (hydroxyl-methyl-glutaryl-CoA reductase inhibitors) in patients with non-metastatic breast cancer (stage I, II, & III).

Full description

Worldwide, BC is the most frequently diagnosed life-threatening cancer in women. In EGYPT, breast cancer is the foremost oncologic problem, contributing to 20% of all cancers and 43% of female cancers. Metformin and atorvastatin have anti-tumor effects. To date, there are limited data to investigate and compare the anti-tumor effect between metformin and statins in patients with breast cancer.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with radiologically and histologically (biopsy) confirmed diagnosis of breast cancer and with stage I, II, and stage III breast cancer according to the American Joint Committee on Cancer (TNM staging system of breast cancer).
• Patients with no contraindication for chemotherapy, metformin, or statins
• Females aged ≥ 18 years old
• Performance status < 2 according to the Eastern Cooperative Oncology Group (ECOG) score

Exclusion criteria

• Patients with metastatic breast cancer (stage IV)
• Pregnant or lactating women.
• Patients with hepatic or renal impairment.
• Patients with myopathy.
• Patients with any condition predispose to acidosis (COPD, heart failure, ....)
• Patients who had dementia, mental retarded, and any psychiatric condition that would prohibit the understanding or signing of informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 3 patient groups, including a placebo group

control group

Placebo Comparator group

Description:

30 patients who will serve as a control group and will receive placebo tablets

Treatment:

Drug: Placebo, metformin and atorvastatin

metformin group

Active Comparator group

Description:

30 patients who will receive metformin 1000 mg/day.

Treatment:

Drug: Placebo, metformin and atorvastatin

atorvastatin group

Active Comparator group

Description:

30 patients who will receive atorvastatin 20 mg/day.

Treatment:

Drug: Placebo, metformin and atorvastatin