Clinical trialNCT05763992UnknownPhase 2Interventional

Targeting Triple Negative BREAst Cancer Metabolism With a Combination of Chemoimmunotherapy and a FASTing-like Approach in the Preoperative Setting: the BREAKFAST 2 Trial

SponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoEnrollment145Breast CancerDietary ExposureFastingTriple Negative Breast Cancer

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Italian, multicenter, open-label, two-arm, comparative, randomized phase II study investigating if the addition of the experimental metabolic intervention consisting in cycles of Fasting-Like Approach, as administered every three weeks up to a maximum of 8 consecutive cycles, is able to increase the anticancer activity of standard preoperative chemo-immunotherapy in patients with localized invasive Triple Negative Breast Cancer.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Alberto Zambelli, MD
Humanitas Research Hospital, Via Alessandro Manzoni 56, 20089 Rozzano
Principal Investigator
clinicaltrials.gov ↗
Andrea Botticelli, MD
"Sapienza" University of Rome, 00185, Rome
Principal Investigator
clinicaltrials.gov ↗
Carla Strina, MD
A.O. "Istituti Ospitalieri", Viale Concordia 1, 26100 Cremona
Principal Investigator
clinicaltrials.gov ↗
Maria Vittoria Dieci, MD
Istituto Oncologico Veneto, Via Gattamelata 64, 35128 Padova, Italy
Principal Investigator
clinicaltrials.gov ↗
Matteo Lambertini, MD
IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 16132 Genova
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗
Monica Iorfida, MD
Istituto Europeo di Oncologia
Principal Investigator
clinicaltrials.gov ↗
Sabino De Placido, MD
University of Naples Federico II, Via Sergio Pansini 5, 80131 Naples
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Italy

Fondazione Irccs Istituto Nazionale Dei Tumori
Milan, Italy
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 15 May 2023
Primary completion: 15 May 2025
Completion: 15 May 2026
Last update posted: 18 May 2023
Registered enrollment: 145
Registry id: NCT05763992

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.