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

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Drug: Chemotherapy; Drug: Metformin plus chemotherapy

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 Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Banī Suwayf, Egypt
    • Beni-Seuf University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Metformin group; Non Diabetic metastatic breast cancer Patients will take metformin 1 gm. twice daily (Nathan 2009) along with standard chemotherapy	Drug: Metformin plus chemotherapy; determine the effect of metformin along with standard chemotherapy
Other: control group; Non Diabetic metastatic breast cancer Patients will take standard chemotherapy only	Drug: Chemotherapy; standard chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Overall survival (OS)	the time period from the start of trial till death or end of follow-up	6 months
Progression-free survival	from the time between start of the trial and recurrence or disease progression, or end of follow-up	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hager salah el din
• Investigators: Study Director: ahmed a berry, PhD, Faculty of Medicine, Beni Suef University; Study Director: ahmed h shaaban, MD, Faculty of Medicine, Beni Suef University; Study Director: hoda m rabea, PhD, Faculty of pharmacy, Beni Suef University

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2019
• Primary Completion (Actual): April 20, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: October 25, 2019
• First Submitted That Met QC Criteria: October 26, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Actual): December 7, 2021
• Last Update Submitted That Met QC Criteria: December 5, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: metformin; non metastatic breast cancer; non-diabetic
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: FWA00015574/6-01-2019/korany

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: upon request
• IPD Sharing Time Frame: 3 MONTHS
• IPD Sharing Access Criteria: hager.salah@rocketmail.com
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No