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Calorie Restriction With or Without Metformin in Triple Negative Breast Cancer

NCT04248998 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-01-18

No results posted yet for this study

Summary

Glucose starvation and metformin have synergistic antitumor effects that are mediated through the concomitant inhibition of glycolysis and mitochondrial oxidative phosphorylation. The BREAKFAST trial will evaluate the antitumor activity of combining cyclic fasting-mimicking diet (FMD), which reproduces the in vitro effects of glucose starvation, plus/minus metformin with standard preperative anthracycline-taxane chemotherapy in patients with stage I-III TNBC

Conditions

  • Triple-negative Breast Cancer

Interventions

DIETARY_SUPPLEMENT

Fasting-mimicking diet

Cyclic, 5-day, calorie-restricted (600 KCal on day 1; 300 KCal on days 2-5), low-carbohydrate, low protein diet every three weeks

DRUG

Metformin

Metformin 850 mg twice a day

DRUG

Preoperative chemotherapy

Chemotherapy will consist of: * four triweekly cycles of doxorubicin 60 mg/mq plus cyclophosphamide 600 mg/mq, followed by * twelve consecutive cycles of weekly paclitaxel 80 mg/mq

Sponsors & Collaborators

  • IFOM ETS - The AIRC Institute of Molecular Oncology

    collaborator OTHER

  • European Institute of Oncology

    collaborator OTHER

  • University of Milan

    collaborator OTHER

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    lead OTHER

Principal Investigators

  • Filippo de Braud, Professor · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  • Claudio Vernieri, M.D. PhD · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-05
Primary Completion
2024-05-01
Completion
2024-05-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04248998 on ClinicalTrials.gov