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

Phase 2

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: Metformin plus chemotherapy; Drug: Chemotherapy

• Registration Number: NCT04143282
• Lead Sponsor: Hager salah el din

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2019-10-20
• Study First Submitted: 2019-10-25
• Study First Submitted QC: 2019-10-26
• Study First Posted: 2019-10-29
• Primary Completion: 2020-04-20
• Study Completion: 2020-06-30
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-05
• Last Update Posted: 2021-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 250

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin group	Metformin plus chemotherapy	Non Diabetic metastatic breast cancer Patients will take metformin 1 gm. twice daily (Nathan 2009) along with standard chemotherapy
control group	Chemotherapy	Non Diabetic metastatic breast cancer Patients will take standard chemotherapy only

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	6 months	the time period from the start of trial till death or end of follow-up
Progression-free survival	6 months	from the time between start of the trial and recurrence or disease progression, or end of follow-up
The radiologic response rate	3 months	The Response Evaluation Criteria in Solid Tumors (RECIST 1.1) was used to evaluate the response to chemotherapy alone in case of control arm and chemotherapy plus metformin in case of drug arm for breast cancer with distant metastasis

Secondary Outcome Measures

Name	Time	Method
Insulin Growth like Factor -1 (IGF-1) at base line and after 3 cycle.	3 months	measure blood Insulin Growth like Factor -1 (IGF-1) at the begining of trial then after 3 months at the end of 3 cycles (each cycle arround 28 days )

Trial Locations

Locations (1)

Beni-Seuf University Hospital; 🇪🇬 Banī Suwayf, Egypt