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

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04143282
• Other study ID #: FWA00015574/6-01-2019/korany
• Status: Completed
• Phase: Phase 2
• Start date: October 20, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: December 2021
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: June 30, 2020
• Est. primary completion date: April 20, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Metformin plus chemotherapy
determine the effect of metformin along with standard chemotherapy
• Chemotherapy
standard chemotherapy

Locations

Country	Name	City	State
Egypt	Beni-Seuf University Hospital	Bani Suwayf

Sponsors (1)

Lead Sponsor	Collaborator
Hager salah el din

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The radiologic response rate	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	3 months
Primary	Overall survival (OS)	the time period from the start of trial till death or end of follow-up	6 months
Primary	Progression-free survival	from the time between start of the trial and recurrence or disease progression, or end of follow-up	6 months
Secondary	Insulin Growth like Factor -1 (IGF-1) at base line and after 3 cycle.	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 )	3 months