NCT04143282

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

December 7, 2021

Status Verified

December 1, 2021

Enrollment Period

6 months

First QC Date

October 25, 2019

Last Update Submit

December 5, 2021

Conditions

Metastatic Breast Cancer

Keywords

metforminnon metastatic breast cancernon-diabetic

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Insulin Growth like Factor -1 (IGF-1) at base line and after 3 cycle.

    3 months

Study Arms (2)

Metformin group

EXPERIMENTAL

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

Drug: Metformin plus chemotherapy

control group

OTHER

Non Diabetic metastatic breast cancer Patients will take standard chemotherapy only

Drug: Chemotherapy

Interventions

Metformin plus chemotherapyDRUG

determine the effect of metformin along with standard chemotherapy

Metformin group
ChemotherapyDRUG

standard chemotherapy

control group

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsmetastatic breast cancer female
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The non-diabetic patients will be included in the study if they meet the following criteria:
  • Confirmed metastatic breast cancer (IV stage) radiologically or by clinical evaluation receiving chemotherapy
  • Age between 18- 70 years.
  • Life expectancy at least 6 months

You may not qualify if:

  • The patients will be excluded from the study if they have the following criteria:
  • Bad prognosis disease: Criteria defined as the following
  • If patient \>70 years
  • If patient has bad site metastasis (brain)
  • 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 \[16\].
  • 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 .
  • Diabetic patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-Seuf University Hospital

Banī Suwayf, Egypt

Location

Related Publications (1)

  • Salah H, Rabea H, Sheemy MS, Rabie AI, Moustafa HAM, Elberry AA, Hassan A. Targeting insulin-like growth factor-1 (IGF-1) by using metformin in non-diabetic metastatic breast cancer female patients: a randomized controlled trial. Cancer Chemother Pharmacol. 2025 Jun 28;95(1):64. doi: 10.1007/s00280-025-04791-8.

    PMID: 40579605DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

MetforminDrug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsTherapeutics

Study Officials

  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
pharmacist

Study Record Dates

First Submitted

October 25, 2019

First Posted

October 29, 2019

Study Start

October 20, 2019

Primary Completion

April 20, 2020

Study Completion

June 30, 2020

Last Updated

December 7, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will share

upon request

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
3 MONTHS
Access Criteria
hager.salah@rocketmail.com

Locations

EG(1)