NCT04387630

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 11, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 14, 2020

Completed
22 days until next milestone

Study Start

First participant enrolled

June 5, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

2 years

First QC Date

May 11, 2020

Last Update Submit

June 8, 2020

Conditions

Breast Cancer

Keywords

breast cancermetforminanti-tumor immunity

Outcome Measures

Primary Outcomes (1)

  • Clinical Response rate

    Response to preoperative therapy as per ultrasonographic tumor size assessment. A responder will have \> 50% decrease in the size of the primary tumor without appearance of new lesions.

    at three months from starting therapy.

Other Outcomes (1)

  • T-cell cytotoxic markers.

    procedure

Study Arms (2)

metformin group

EXPERIMENTAL

metformin 850 mg once daily increased within 3 weeks to a maximum dose of 2550 mg on three divided daily doses. Neoadjuvant cytotoxic chemotherapy as per MDT (multi-disciplinary team) decision. Patients scheduled for AC-T (adriamycin, Cyclophosphamide, paclitaxel) or AC (adriamycin, cyclophosphamide) will be eligible to randomization.

Drug: Metformin

Placebo group

PLACEBO COMPARATOR

placebo. Neoadjuvant cytotoxic chemotherapy as per MDT(multi-disciplinary team) decision. Patients scheduled for AC-T (adriamycin, Cyclophosphamide, paclitaxel) or AC (adriamycin, cyclophosphamide) will be eligible to randomization.

Drug: Placebo oral tablet

Interventions

MetforminDRUG

Oral hypoglycemic drug. Initial dose 500-850 mg/d. incrementally increased to a maximum daily dose of 2550 mg in three divided doses.

Also known as: Glucophage
metformin group
Placebo oral tabletDRUG

Simethicone 60 mg three times daily.

Placebo group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven breast carcinoma.
  • American Society of Anesthesiology (ASA) score I-II.
  • Candidate for neoadjuvant chemotherapy as per hospital's protocol.
  • Clinically measurable tumor.
  • No evidence of distant metastasis.
  • Normal renal and liver functions.
  • Non-diabetics.

You may not qualify if:

  • Pregnant or lactating women.
  • Metastatic breast cancer patients.
  • Patients with hepatic impairment.
  • Patients with renal impairment.
  • Diabetics.
  • Patients unwilling to participate or withdrawing from the trial.
  • Psychological/ mental impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Cancer center

Al Mansurah, 35516, Egypt

RECRUITING

Related Publications (3)

  • Eikawa S, Nishida M, Mizukami S, Yamazaki C, Nakayama E, Udono H. Immune-mediated antitumor effect by type 2 diabetes drug, metformin. Proc Natl Acad Sci U S A. 2015 Feb 10;112(6):1809-14. doi: 10.1073/pnas.1417636112. Epub 2015 Jan 26.

    PMID: 25624476BACKGROUND

  • Pearce EL, Walsh MC, Cejas PJ, Harms GM, Shen H, Wang LS, Jones RG, Choi Y. Enhancing CD8 T-cell memory by modulating fatty acid metabolism. Nature. 2009 Jul 2;460(7251):103-7. doi: 10.1038/nature08097. Epub 2009 Jun 3.

    PMID: 19494812BACKGROUND

  • Coyle C, Cafferty FH, Vale C, Langley RE. Metformin as an adjuvant treatment for cancer: a systematic review and meta-analysis. Ann Oncol. 2016 Dec;27(12):2184-2195. doi: 10.1093/annonc/mdw410. Epub 2016 Sep 28.

    PMID: 27681864BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Metformin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Osama Hussein, MD, PhD

    Mansoura University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Osama Hussein

CONTACT

0020 1099 8151 10osama.hussein@mail.mcgill.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

May 11, 2020

First Posted

May 14, 2020

Study Start

June 5, 2020

Primary Completion

June 5, 2022

Study Completion

May 1, 2023

Last Updated

June 11, 2020

Record last verified: 2020-06

Locations

EG(1)