NCT04559308

Brief Summary

Several clinical trials have addressed the promising anticancer effect of metformin on the survival benefits, clinical response, and pathological response of breast cancer patients. Therefore, this study will assess the anticancer effect of metformin when added to the neoadjuvant chemotherapy protocol of non-diabetic breast cancer patients. In addition to, the impact of metformin addition to the neoadjuvant chemotherapy on the quality of life of breast cancer patients.

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
80

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Jun 2019

Shorter than P25 for phase_2 breast-cancer

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

Study Start

First participant enrolled

June 1, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2020

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2020

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

1.3 years

First QC Date

August 22, 2020

Last Update Submit

September 16, 2020

Conditions

Breast Cancer

Keywords

MetforminBreast cancer

Outcome Measures

Primary Outcomes (1)

  • Clinical benefit rate (Tumor size)

    Tumor size measured in calipers from baseline till the last cycle of neoadjuvant chemotherapy.

    8 months

Secondary Outcomes (4)

  • Pathological complete response

    8 months

  • Number of participants with metformin-related adverse events

    8 months

  • The effect of metformin on the quality of life of breast cancer patients

    8 months

  • The effect of metformin on the quality of life of breast cancer patients

    8 months

Study Arms (2)

metformin arm

EXPERIMENTAL

4 cycles (Doxorubicin+Cyclophosphamide) followed by 12 cycles Paclitaxel+ Metformin (1000 mg twice daily) followed by surgery.

Drug: MetforminDrug: Chemotherapy

control arm

ACTIVE COMPARATOR

4 cycles (Doxorubicin+Cyclophosphamide) followed by 12 cycles Paclitaxel followed by surgery.

Drug: Chemotherapy

Interventions

MetforminDRUG

first-line anti-diabetic drug

Also known as: Glucophage
metformin arm
ChemotherapyDRUG

First line neoadjuvant chemotherapy protocol

Also known as: Doxorubicin, Cyclophosphamide, Paclitaxel
control armmetformin arm

Eligibility Criteria

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

You may qualify if:

  • Non-diabetic breast cancer patients, receiving neoadjuvant chemotherapy treatment.
  • Female Age between 18- 65 years.
  • Written informed consent.

You may not qualify if:

  • Known hypersensitivity reaction to Metformin.
  • Intolerable Metformin GI complaints.
  • Patients at risk of lactic acidosis.
  • Diabetic breast cancer patients.
  • Body Mass Index \< 18.5 (underweight breast cancer patients).
  • Renal impairment, eGFR \<45 mL/min/1.73 m².

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-suef university

Banī Suwayf, 11815, Egypt

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

MetforminDrug TherapyDoxorubicinCyclophosphamidePaclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsTherapeuticsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenes

Study Officials

  • Ahmed A El Berry, Ph.D.

    Beni-Suef University

    STUDY DIRECTOR

Central Study Contacts

Hadeer M Ehab, M.Sc.

CONTACT

01020483388hadeer.ehab7785@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study is an open-labeled, parallel, randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Pharmacy Researcher

Study Record Dates

First Submitted

August 22, 2020

First Posted

September 22, 2020

Study Start

June 1, 2019

Primary Completion

September 15, 2020

Study Completion

October 1, 2020

Last Updated

September 22, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share

Study protocol, safety and efficacy criteria, and statistical analysis.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
1 year
Access Criteria
sent by e-mail

Locations

EG(1)