NCT05840068

Brief Summary

The purpose of this study is to examine the impact of metformin as an adjuvant to chemotherapy on IGF levels in both progressing and non progressing cases of metastatic breast cancer in female patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2020

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

June 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
Last Updated

May 3, 2023

Status Verified

May 1, 2023

Enrollment Period

1.2 years

First QC Date

April 21, 2023

Last Update Submit

May 2, 2023

Conditions

Breast Cancer Female

Keywords

MetforminBreast cancerIGF

Outcome Measures

Primary Outcomes (1)

  • IGF-1 levels

    IGF-1 levels were measured before and after treatment.

    6 months.

Secondary Outcomes (1)

  • Progression-free survival (PFS)

    1 Year

Study Arms (2)

Metformin and Chemotherapy

EXPERIMENTAL

Metformin (500 mg twice daily) plus chemotherapy is administered to Group A (n=57)

Drug: MetFORMIN 500 Mg Oral TabletDrug: Chemotherapy

Chemotherapy alone

OTHER

Chemotherapy is administered alone to Group B (n=50).

Drug: Chemotherapy

Interventions

MetFORMIN 500 Mg Oral TabletDRUG

MetFORMIN 500 Mg Oral Tablet

Also known as: Glucophage 500 oral tablet and Chemotherapy
Metformin and Chemotherapy
ChemotherapyDRUG

The standard chemotherapy protocol developed by the South Egypt Cancer Institute (SECI).

Also known as: Chemotherapy alone
Chemotherapy aloneMetformin and Chemotherapy

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients with MBC
  • patients older than 18
  • nondiabetic patients
  • patients who received only chemotherapy

You may not qualify if:

  • patients with non-metastatic breast cancer
  • patients receiving hormonal therapy or radiotherapy
  • patients with diabetes
  • history of cardiac diseases
  • hypersensitivity, or allergy to metformin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marian S. Boshra

Banī Suwayf, 62514, Egypt

Location

Related Publications (3)

  • Ko KP, Ma SH, Yang JJ, Hwang Y, Ahn C, Cho YM, Noh DY, Park BJ, Han W, Park SK. Metformin intervention in obese non-diabetic patients with breast cancer: phase II randomized, double-blind, placebo-controlled trial. Breast Cancer Res Treat. 2015 Sep;153(2):361-70. doi: 10.1007/s10549-015-3519-8. Epub 2015 Aug 21.

    PMID: 26293146BACKGROUND

  • Essa NM, Salem HF, Elgendy MO, Gabr A, Omran MM, Hassan NA, Tashkandi HM, Harakeh S, Boshra MS. Efficacy of Metformin as Adjuvant Therapy in Metastatic Breast Cancer Treatment. J Clin Med. 2022 Sep 20;11(19):5505. doi: 10.3390/jcm11195505.

    PMID: 36233373BACKGROUND

  • Pollak M. Insulin and insulin-like growth factor signalling in neoplasia. Nat Rev Cancer. 2008 Dec;8(12):915-28. doi: 10.1038/nrc2536.

    PMID: 19029956RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

MetforminTabletsDrug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsDosage FormsPharmaceutical PreparationsTherapeutics

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 21, 2023

First Posted

May 3, 2023

Study Start

June 1, 2020

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

May 3, 2023

Record last verified: 2023-05

Locations

EG(1)