The Effect of Metformin on Breast Cancer Patients

Phase 2

• Conditions: Breast Cancer
• Interventions: Drug: Metformin; Drug: Chemotherapy

• Registration Number: NCT04559308
• Lead Sponsor: Beni-Suef University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2020-08-22
• Status Verified: 2020-09
• Primary Completion: 2020-09-15
• Study First Submitted QC: 2020-09-16
• Last Update Submitted: 2020-09-16
• Study First Posted: 2020-09-22
• Last Update Posted: 2020-09-22
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
metformin arm	Metformin	4 cycles (Doxorubicin+Cyclophosphamide) followed by 12 cycles Paclitaxel+ Metformin (1000 mg twice daily) followed by surgery.
metformin arm	Chemotherapy	4 cycles (Doxorubicin+Cyclophosphamide) followed by 12 cycles Paclitaxel+ Metformin (1000 mg twice daily) followed by surgery.
control arm	Chemotherapy	4 cycles (Doxorubicin+Cyclophosphamide) followed by 12 cycles Paclitaxel followed by surgery.

Primary Outcome Measures

Name	Time	Method
Clinical benefit rate (Tumor size)	8 months	Tumor size measured in calipers from baseline till the last cycle of neoadjuvant chemotherapy.

Secondary Outcome Measures

Name	Time	Method
Pathological complete response	8 months	The absence of residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy.
Number of participants with metformin-related adverse events	8 months	Safety and tolerability of conventional anti-diabetic dose of metformin use in breast cancer patients.
The effect of metformin on the quality of life of breast cancer patients	8 months	A comparison between the metformin arm and the control arm in the change of quality of life from baseline using the European Organization for Research and Treatment of Cancer (EORTC QLQ BR45).Scoring of the EORTC QLQ-Br45 is performed according to the EORTC scoring manual. After the scoring procedures, all the responses to likert-scale items were linearly transformed to a 0-100 scale. Higher scores for functional scales and the global quality of life scale, indicate better quality of life, while for symptom scales and single items, a higher score indicates a higher severity of the symptoms and worse quality of life

Trial Locations

Locations (1)

Beni-suef university; 🇪🇬 Banī Suwayf, Egypt