The Effect of Metformin on Breast Cancer Patients

Beni-Suef University

Status and phase: Unknown; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Chemotherapy; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT04559308

BSU

Details and patient eligibility

About

Several clinical trials have addressed the promising anticancer effect of metformin on the survival benefits, clinical response, and pathological response of breast cancer patients.

Therefore, this study will assess the anticancer effect of metformin when added to the neoadjuvant chemotherapy protocol of non-diabetic breast cancer patients. In addition to, the impact of metformin addition to the neoadjuvant chemotherapy on the quality of life of breast cancer patients.

Full description

This study is conducted to assess the effect of metformin addition to the chemotherapy protocol of non-diabetic breast cancer patients compared to the control group (non-metformin users) in the neoadjuvant setting. Evaluation of the the clinical benefit rate and the rate of pathological complete response will be conducted. In addition, a correlation between the beneficial effect of metformin and the serum concentration of metformin. Also, a comparison in the quality of life between the metformin group and the control group will be evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) and (EORTC QLQ BR45) questionnaires will be done.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Non-diabetic breast cancer patients, receiving neoadjuvant chemotherapy treatment.
2. Female Age between 18- 65 years.
3. Written informed consent.

Exclusion criteria

1. Known hypersensitivity reaction to Metformin.
2. Intolerable Metformin GI complaints.
3. Patients at risk of lactic acidosis.
4. Diabetic breast cancer patients.
5. Body Mass Index < 18.5 (underweight breast cancer patients).
6. Renal impairment, eGFR <45 mL/min/1.73 m².

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

metformin arm

Experimental group

Description:

4 cycles (Doxorubicin+Cyclophosphamide) followed by 12 cycles Paclitaxel+ Metformin (1000 mg twice daily) followed by surgery.

Treatment:

Drug: Metformin

Drug: Chemotherapy

control arm

Active Comparator group

Description:

4 cycles (Doxorubicin+Cyclophosphamide) followed by 12 cycles Paclitaxel followed by surgery.

Treatment:

Drug: Chemotherapy