Evaluation of the Effect of Metformin on Metastatic Breast Cancer as Adjuvant Treatment

Hager salah el din

Status and phase: Completed; Phase 2

Conditions: Metastatic Breast Cancer

Treatments: Drug: Metformin plus chemotherapy; Drug: Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04143282

FWA00015574/6-01-2019/korany

Details and patient eligibility

About

This study aims to determine the effect of metformin along with standard cancer treatment, and its effect on the prognosis of the metastatic breast in non-diabetic patients.

Full description

the role of metformin when combined with traditional metastatic breast cancer treatment in non-diabetic patients compared to diabetic patients who are not using metformin. In this randomized control study, there will be a demonstration either it is effective to suppress tumor burden or not through normal screening for tumor.

Enrollment: 250 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The non-diabetic patients will be included in the study if they meet the following criteria:

  1. Confirmed metastatic breast cancer (IV stage) radiologically or by clinical evaluation receiving chemotherapy
  2. Age between 18- 70 years.
  3. Life expectancy at least 6 months

Exclusion criteria

• The patients will be excluded from the study if they have the following criteria:

  1. Bad prognosis disease: Criteria defined as the following

     • If patient >70 years
     • If patient has bad site metastasis (brain)

  2. Hypersensitivity for metformin: if happened patient will be treated as following

     • Pheniramine Maleate 3 times daily for 7 days and Tablet Dexamethasone 1mg daily in 2 divided doses for 5 days [16].

  3. Any condition associated with increased risk of metformin-associated lactic acidosis (e.g., congestive heart failure defined as New York Heart Association {NYHA} Class III or IV functional status; the history of acidosis of any type, severe infections, kidney or liver disease, respiratory disease, seizures .

  4. Diabetic patients.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Metformin group

Experimental group

Description:

Non Diabetic metastatic breast cancer Patients will take metformin 1 gm. twice daily (Nathan 2009) along with standard chemotherapy

Treatment:

Drug: Metformin plus chemotherapy

control group

Other group

Description:

Non Diabetic metastatic breast cancer Patients will take standard chemotherapy only

Treatment:

Drug: Chemotherapy