Trial | NCT04559308  Report issue

Official Title

The Effect of Metformin on Breast Cancer Patients

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    Metformin ...

  • Study Participants

    80
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.
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 Started
Jun 01
2019
Primary Completion
Sep 15
2020
Study Completion
Oct 31
2020
Anticipated
Last Update
Sep 22
2020

Drug Metformin

first-line anti-diabetic drug

  • Other names: Glucophage

Drug Chemotherapy

First line neoadjuvant chemotherapy protocol

  • Other names: Doxorubicin, Cyclophosphamide, Paclitaxel

metformin arm Experimental

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

control arm Active Comparator

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

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

Known hypersensitivity reaction to Metformin.
Intolerable Metformin GI complaints.
Patients at risk of lactic acidosis.
Diabetic breast cancer patients.
Body Mass Index < 18.5 (underweight breast cancer patients).
Renal impairment, eGFR <45 mL/min/1.73 m².
No Results Posted