Trials Sponsors Conditions Drugs Pricing

Conditions

Triple negative breast cancer

Outcome Measures

Primary Outcomes (1)

Pathologic complete response (pCR), as defined as the absence of residual tumor cells in both breast tissue and axillary lymph nodes.

Secondary Outcomes (13)

Relapse free survival (RFS), as defined as the time from surgery to tumor recurrence, either local or distant
Distant metastasis free survival (DMFS), as defined as the time from surgery to the occurrence of distant metastases
Overall Survival (OS), as defined as the time from randomization to the date of death. Patients alive at time of data cut-off and analysis will be censored at their last contact date
Metabolic biomarkers (e.g. plasma glucose, insulin, insulin-like growth factor 1 (IGF-1) levels and whole blood and plasma lipid profile, fecal microbiota) assessed at baseline and at each chemotherapy cycle
Role of DNA repair, mTORC 1, PP2A, autophagy and Beclin 1 pathways in the efficacy of the experimental treatments, defined as the rate of pCRs
+8 more secondary outcomes

Interventions

METFORAL 850 mg compresse rivestite con filmType not reported

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
METFORAL 850 mg compresse rivestite con film
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

METFORAL 850 mg compresse rivestite con film
Named ingredient: Metformin hydrochloride
View registry record

Eligibility Criteria

Sexfemale

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Female sex
Age ≥ 18 and ≤ 75 years.
Evidence of a personally signed and dated informed consent document (ICD) indicating that the patient has been informed of all pertinent aspects of the study before enrollment

Sponsors & Collaborators

Fondazione IRCCS Istituto Nazionale Dei Tumori
Type not reportedlead

Study Sites (1)

Fondazione IRCCS Istituto Nazionale Dei Tumori

Milan, 20133, Italy

Filippo de Braud0223902148 debraud_studiclinici@istitutotumori.mi.it

Central Study Contacts

Clinical Trials Center

+390223902148 debraud_studiclinici@istitutotumori.mi.it

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

October 26, 2023

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2023-508920-37-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-31 04:17:17 UTC

Locations

IT(1)

You may not qualify if:

Prior systemic treatment for breast cancer or other malignancies within 5 years of treatment enrollment.
Prior treatment with anthracyclines
Diagnosis of other malignancies in advanced stages (unresectable, locally advanced or metastatic), or that required systemic (neo)adjuvant chemotherapy in the previous 5 years. Other malignancies diagnosed more than 5 years before the diagnosis of breast cancer must have been radically treated without evidence of relapse at the moment of patient enrollment in the trial
Body mass index (BMI) < 20 kg/m^2.
History of alcohol abuse.
Non-intentional weight loss ≥ 5% in the previous 3 months, unless the patient has a BMI > 22 kg/m^2 and weight loss has been lower than 10% at the time of enrollment in the study; or non-intentional weight loss of ≥ 10% in the previous 3 months, unless the patients has a BMI > 25 kg/m^2 and weight loss has been lower than 15% at the time of the enrollment in the study. In both cases, weight must have been stable for at least one month before study enrollment
Active pregnancy or breast feeding.
Known active B or C hepatitis or human immunodeficiency virus (HIV) infection, or occasional finding of active hepatitis B/C infection during screening tests before chemotherapy initiation, as defined as positive polymerase chain reaction (PCR) testing for HBV-DNA and HCV-RNA and qualitative PCR for HIV-RNA, or requiring active treatment at study enrollment.
Serious infections in the previous 4 weeks before the FMD initiation, including, but not limited to, potential hospitalizations for complications of infections, bacteriemia or serious pneumonitis.
Active autoimmune diseases requiring systemic treatments (e.g. systemic steroids or immune suppressants).
Active chronic therapy with systemic steroids at a dose ≥ 10 mg per day of prednisone or equivalent at study enrollment
Known recent diagnosis of hypothyroidism requiring systemic replacement hormonal therapy and without stabilization of hormonal profile (fT3, fT4 and TSH within the normal range).
Diagnosis of type 1 or 2 diabetes mellitus requiring pharmacologic therapy (including, but not limited to, insulin, secretagogues and metformin). A diagnosis of type 2 diabetes mellitus not requiring pharmacological treatments based on the judgment of a diabetologist, is compatible with patient enrollment in the trial.
Active gastric or intestinal ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small intestine resection.
Anamnesis of clinically significant heart disease including: a. angina pectoris, coronary bypass, symptomatic pericarditis, myocardial infarction in the previous 12 months from the beginning of experimental therapy; b. congestive heart failure (NYHA III-IV).
+5 more criteria

Targeting triple negative BREAst cancer metabolism with a combination of chemotherapy and a diet mimicking FASTing plus/minus metformin in the preoperative setting: the BREAKFAST trial

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Locations

You may not qualify if:

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Locations

You may not qualify if: