NCT04387630 is a Phase 2, PHASE3 clinical trial of Metformin in Breast Cancer, sponsored by Mansoura University.

Who is sponsoring NCT04387630?

NCT04387630 is sponsored by Mansoura University.

What drugs are being tested in NCT04387630?

Interventions in NCT04387630: Metformin, Placebo oral tablet.

What condition does NCT04387630 study?

NCT04387630 studies Breast Cancer.

Is NCT04387630 still recruiting?

NCT04387630 is currently status unknown. Last updated 11 June 2020.

Last reviewed 2020-06-11 · How we verify

NCT04387630

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Neoadjuvant Chemotherapy With or Without Metformin in Early Breast Cancer.

Status unknown Phase 2, PHASE3 Last updated 11 June 2020

What this trial tests

Phase 2, PHASE3 trial testing Metformin in Breast Cancer in 120 participants. Status unknown.

Timeline

5 June 2020

Primary endpoint
5 June 2022

1 May 2023

Quick facts

Lead sponsor	Mansoura University
Phase	Phase 2, PHASE3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	5 June 2020
Primary completion	5 June 2022
Estimated completion	1 May 2023
Sites	1 location across Egypt

Drugs / interventions tested

Metformin (metformin) — full drug profile →
Placebo oral tablet — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →

Sponsor

Mansoura University

Who can join

Adults 18 to 65, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Metformin is a widely used anti-diabetic drug. Several studies have pointed out a potentially beneficial effect of metformin therapy in diabetic cancer patients. Several studies are investigating the anti-tumor effect of metformin in early breast cancer. However, the enhancing effect of metformin on anti-tumor immunity has only been demonstrated in animal models. This study examines the immune effect of metformin in breast cancer patients treated with preoperative chemotherapy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

New Insight into the Effects of Metformin on Diabetic Retinopathy, Aging and Cancer: Nonapoptotic Cell Death, Immunosuppression, and Effects beyond the AMPK Pathway.
Hsu SK, Cheng KC, Mgbeahuruike MO, Lin YH, et al · · 2021 · cited 56× · PMID 34502359 · DOI 10.3390/ijms22179453
RETRACTED: Metformin and Breast Cancer: Where Are We Now?
Cejuela M, Martin-Castillo B, Menendez JA, Pernas S. · · 2022 · cited 55× · PMID 35269852 · DOI 10.3390/ijms23052705
Autophagy Modulators in Cancer Therapy.
Buzun K, Gornowicz A, Lesyk R, Bielawski K, et al · · 2021 · cited 50× · PMID 34071600 · DOI 10.3390/ijms22115804
Repurposing non-oncology small-molecule drugs to improve cancer therapy: Current situation and future directions.
Fu L, Jin W, Zhang J, Zhu L, et al · · 2022 · cited 47× · PMID 35256933 · DOI 10.1016/j.apsb.2021.09.006
Druggability of lipid metabolism modulation against renal fibrosis.
Chen YY, Chen XG, Zhang S. · · 2022 · cited 43× · PMID 33990764 · DOI 10.1038/s41401-021-00660-1
Hyperglycemia and Chemoresistance in Breast Cancer: From Cellular Mechanisms to Treatment Response.
Qiu J, Zheng Q, Meng X. · · 2021 · cited 43× · PMID 33718202 · DOI 10.3389/fonc.2021.628359
Beyond the Double-Strand Breaks: The Role of DNA Repair Proteins in Cancer Stem-Cell Regulation.
Nathansen J, Meyer F, Müller L, Schmitz M, et al · · 2021 · cited 34× · PMID 34638302 · DOI 10.3390/cancers13194818
Advances in Analyzing the Breast Cancer Lipidome and Its Relevance to Disease Progression and Treatment.
Ward AV, Anderson SM, Sartorius CA. · · 2021 · cited 28× · PMID 34914014 · DOI 10.1007/s10911-021-09505-3

Verify or expand the search:

Other trials of Metformin

Trials testing the same drug.

NCT07275359 — Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations · Phase 1 · not yet recruiting
NCT07520110 — Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis · Phase 3 · not yet recruiting
NCT07007221 — Clinical Trials to Evaluate Metformin to Treat Depression in People Living With HIV · Phase 2 · not yet recruiting
NCT07585396 — Inositol in Letrozol Resistant PCOS Women · Phase 2, PHASE3 · not yet recruiting
NCT07226453 — Target Validation and Efficacy of Metformin in Patients With Posterior Fossa Group A (PFA) Ependymoma · Phase 2 · not yet recruiting

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting

Other Mansoura University trials

Trials by the same sponsor.

NCT05785377 — Neostigmine as an Adjuvant in Tranversus Abdominis Plane (TAP) Block in Cesarean Section Under Spinal Anesthesia · NA · not yet recruiting
NCT07509567 — Conventional Palatal Crib Versus Bonded Spurs for Anterior Open Bite Treatment · NA · not yet recruiting
NCT07393178 — Efficacy & Safety of High Power vs. Low Power Holmium Laser in Mini-PCNL for Large Renal Stones · NA · not yet recruiting
NCT07436182 — Mitochondrial Redox Modulation in Newly Diagnosed Type 2 Diabetes: A Randomized Controlled Trial Comparing Imeglimin vs. · Phase 4 · not yet recruiting
NCT07534943 — Effectiveness of Oleanolic Acid as Intracanal Medicament on Infectious/Inflammatory Contents in Teeth With Apical Period · NA · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04387630 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mansoura University
Last refreshed: 11 June 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04387630.

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