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CompletedNCT05840068Updated May 3, 2023

IGF Level in Breast Cancer Patients Treated With Metformin

A Phase 4 interventional study of MetFORMIN 500 Mg Oral Tablet and Chemotherapy in Breast Cancer Female, sponsored by Beni-Suef University. Completed at 1 site in Egypt. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-03.

Sponsored by Beni-Suef University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 10 months after the study started (first participant enrolled Jun 2020, registered Apr 2023).
Phase
Phase 4
Study type
Interventional
Enrollment
107
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed description

One hundred and seven women with metastatic breast cancer (MBC) are randomly assigned to either a metformin (500 mg twice daily) or placebo (placebo) group during chemotherapy. All patients followed the standard chemotherapy protocol developed by the South Egypt Cancer Institute (SECI). Blood IGF-1 levels were measured at the start of treatment (baseline) and again six months later.

02

Conditions studied

  • Breast Cancer Female

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Keywords

  • Metformin
  • Breast cancer
  • IGF
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 107 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Beni-Suef University is the lead sponsor of 333 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patients with non-metastatic breast cancer
  • patients receiving hormonal therapy or radiotherapy
  • patients with diabetes
  • history of cardiac diseases
  • hypersensitivity, or allergy to metformin.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
107 participants (actual)

Study arms

  • Experimental
    Metformin and Chemotherapy

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

    Drug: MetFORMIN 500 Mg Oral Tablet · Drug: Chemotherapy

  • Other
    Chemotherapy alone

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

    Drug: Chemotherapy

Interventions

  • DrugMetFORMIN 500 Mg Oral Tablet

    MetFORMIN 500 Mg Oral Tablet

    Also known as: Glucophage 500 oral tablet and Chemotherapy

  • DrugChemotherapy

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

    Also known as: Chemotherapy alone

06

What researchers measure

Primary outcomes

  1. IGF-1 levels

    IGF-1 levels were measured before and after treatment.

    Time frame: 6 months.

Secondary outcomes

  1. Progression-free survival (PFS)

    The measurement values of IGF were divided into two groups, high and low, based on the cut off value. After a year of observation, researchers in both groups compared their progression-free survival (PFS).

    Time frame: 1 Year

07

Study locations

1 site
  • Marian S. Boshra
    Banī Suwayf, 62514, Egypt
08

References and documents

Publications

  • 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. PubMed 26293146 ↗
  • 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. PubMed 36233373 ↗
  • Pollak M. Insulin and insulin-like growth factor signalling in neoplasia. Nat Rev Cancer. 2008 Dec;8(12):915-28. doi: 10.1038/nrc2536. Erratum In: Nat Rev Cancer. 2009 Mar;9(3):224. PubMed 19029956 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05840068
Lead sponsor
Beni-Suef University
Responsible party
Marian S. Boshra (Dr., Beni-Suef University) — Principal investigator
First posted
May 3, 2023
Start date
Jun 1, 2020
Primary completion
Jul 31, 2021
Completion
Jul 31, 2021
Last update
May 3, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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