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Breast Cancer FemalePhase 2METNEONCT04170465

Role of Adding Metformin to Neoadjuvant Chemotherapy in Patients With Breast Cancer (METNEO)

A Phase 2 study testing Metformin Hydrochloride 850 mg Tablets and AC-T chemotherapy regimen in people with Breast Cancer Female, run by Damanhour University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Metformin, the widely prescribed oral hypoglycemic drug, is well known for its established efficacy, favorable safety profile, and low cost. Metformin has recently received increasing attention because of its potential antitumorigenic effects that are thought to be independent of its hypoglycemic effects. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Breast Cancer Female
What is being tested?
Metformin Hydrochloride 850 mg Tablets and AC-T chemotherapy regimen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteEgypt
Study dates
29 Oct 2019to 28 Jun 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Females ≥ 18 years of age and < 65 years.
  • Unilateral or bilateral primary carcinoma of the breast confirmed.
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2.
  • Clinically measurable tumor size who are candidates for neoadjuvant therapy.
  • No evidence of distant metastasis.
  • Normal renal and liver functions.
  • Non-diabetics.

Who cannot join

  • Pregnant or breastfeeding women.
  • Prior cancer chemotherapy.
  • Heart disease or reduced cardiac output with left ventricular ejection fraction < 50%.
  • Metastatic breast cancer patients.
  • Patients with hepatic impairment.
  • Patients with renal impairment.
  • Diabetics.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Damanhour University

    Beheira, 22511

Other trials in Egypt

About this study

Official title: Investigation of the Potential Beneficial Effect of Adding Metformin to Neoadjuvant Chemotherapy in Patients With Breast Cancer (METNEO)

Metformin, the widely prescribed oral hypoglycemic drug, is well known for its established efficacy, favorable safety profile, and low cost. Metformin has recently received increasing attention because of its potential antitumorigenic effects that are thought to be independent of its hypoglycemic effects. It has been extensively studied in preclinical models, which have implicated several molecular pathways in its antitumor activity.

Metformin was proved to have anti-proliferative and apoptotic effects on tumor cells.Moreover, metformin enhances the T-cell mediated immune response to tumor tissue and fights metastases. Also, epidemiological studies have shown that metformin, but not other antidiabetic drugs, reduces cancer incidence and improves survivability in diabetic cancer patients.

The proposed research in this application will investigate two prime questions with regards to the combined use of metformin together with traditional neoadjuvant chemotherapy in breast cancer patients. First, the hypothesis that the simultaneous use of metformin along with doxorubicin/cyclophosphamide/paclitaxel neoadjuvant protocol produces better antitumor outcomes will be tested. Second, the study will examine if the improved apoptotic effect of such regimen is paralleled by exaggerated stimulatory influences on apoptosis biomarkers.

Read the detailed description
  1. Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University.
  2. All participants should agree to take part in this clinical study and will provide informed consent.
  3. Sixty female breast cancer patients, who are candidates for neoadjuvant chemotherapy, will be recruited from the Medical Research Institute, Oncology department, Alexandria University, Alexandria.
  4. The 60 participants will be randomly assigned into 2 arms:
  • Control arm (n=30): will be treated with AC-Taxol regimen (AC: Doxorubicin 60 mg/m2 IV + cyclophosphamide 600 mg/m2 IV) for 4 cycles every 3 weeks. Subsequent Taxol cycles (Paclitaxel 80mg/m2 IV) once weekly for 12 weeks.
  • Metformin arm (n=30): will be treated with the AC-Taxol regimen mentioned above together with Metformin 850 mg tablets orally twice per day (1700 mg/day).
  1. All patients will be submitted to:
  • Full patient history and clinical examination.
  • Routine follow up before each chemotherapy cycle (complete blood picture, liver function tests, renal function tests).
  • Routine Echocardiography before each chemotherapy cycle.
  1. All patients will be monitored for the incidence of chemotherapy toxicities during neoadjuvant therapy.
  2. After completion of the neoadjuvant therapy, participants will undergo surgical tumor removal. The excised tumor will be collected, and the expression of apoptosis biomarkers and the pathologic complete response (pCR) will be assessed.
  3. Patients demographic data will be recorded with respect to age, weight and disease history.
  4. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
  5. Results, conclusion, discussion and recommendations will be given.
Being tested
Metformin Hydrochloride 850 mg Tablets, AC-T chemotherapy regimen
Keywords
Metformin, locally advanced breast cancer, neoadjuvant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Metformin Hydrochloride 850 mg TabletsDrug

    Also called Cidophage 850 mg

    Oral administration of Metformin hydrochloride 850 mg tablets (1700 mg/day) daily until the completion of neoadjuvant chemotherapy cycles

  • AC-T chemotherapy regimenDrug

    Also called AC (doxorubicin [Adriamycin] + cyclophosphamide) followed by paclitaxel (Taxol)

    AC: (Doxorubicin 60 mg/m2 IV + cyclophosphamide 600 mg/m2 IV) for 4 cycles every 3 weeks followed by Taxol cycles (Paclitaxel 80 mg/m2 IV) once weekly for 12 weeks.

Study groups in NCT04170465
Study groupRoleWhat they receive
Metformin groupExperimentalPatients will receive AC-T neoadjuvant chemotherapy in addition to oral metformin HCl (850 mg tablets, twice per day, for 6 months) (n= 30)
Receives: Drug: Metformin Hydrochloride 850 mg Tablets; Drug: AC-T chemotherapy regimen
Control groupActive comparatorPatients will receive AC-T neoadjuvant chemotherapy alone (n= 30)
Receives: Drug: AC-T chemotherapy regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of the effect on tumor apoptosis

    Tissue level of the apoptosis biomarker in the excised tumor.

    Measured: 6 months

  2. Chemotherapy toxicities

    Monitoring the incidence of chemotherapy toxicities during neoadjuvant therapy

    Measured: 6 months

Secondary outcomes (1)

  1. Pathologic complete response rate (pCR)

    Pathologic complete response rate defined as the absence of residual invasive cancer in the resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2019
  2. Study start29 Oct 2019
  3. Primary completion2 Apr 2022
  4. Study completion28 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Trial
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04170465
Sponsor's protocol ID
919PP18
Acronym
METNEO
Status last verified
Nov 2019
First submitted
18 Nov 2019
Last updated
10 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Summary of all relevant data will be shared

Publications

  • Serageldin MA, El-Bassiouny NA, El-Kerm Y, Aly RG, Helmy MW, El-Mas MM, Kassem AB. A randomized controlled study of neoadjuvant metformin with chemotherapy in nondiabetic breast cancer women: The METNEO study. Br J Clin Pharmacol. 2024 Dec;90(12):3160-3175. doi: 10.1111/bcp.16193. Epub 2024 Aug 7.

    PubMed 39113190

  • Serageldin MA, Kassem AB, El-Kerm Y, Helmy MW, El-Mas MM, El-Bassiouny NA. The Effect of Metformin on Chemotherapy-Induced Toxicities in Non-diabetic Breast Cancer Patients: A Randomised Controlled Study. Drug Saf. 2023 Jun;46(6):587-599. doi: 10.1007/s40264-023-01305-4. Epub 2023 May 2.

    PubMed 37131014

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Metformin Hydrochloride 850 mg Tablets and AC-T chemotherapy regimen in people with Breast Cancer Female, run by Damanhour University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the effect on tumor apoptosis (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04170465, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2022.

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