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

PHASE2RecruitingINTERVENTIONAL
Enrollment

145

Participants

Timeline

Start Date

May 15, 2023

Primary Completion Date

May 15, 2025

Study Completion Date

May 15, 2026

Conditions
Breast CancerTriple Negative Breast CancerDietary ExposureFasting
Interventions
DIETARY_SUPPLEMENT

Control diet (ARM A) or Fasting-Like Approach (FLA, ARM B)

Each FLA cycle will consist of 5 consecutive days of a specific FLA scheme, which will be repeated with a three-week interval. The FLA will consist of a plant-based, low-calorie (about 600 Kcal on day 1; about 300 Kcal on day 2 to 5), low-protein, low-carbohydrate diet. The first FLA cycle will start two days prior to the day of first chemo-immunotherapy cycle administration and will continue for two more days after chemotherapy. In the absence of significant contraindications or severe adverse events, subsequent FLA cycles will recur with three-week intervals and will maintain the same timing with respect to chemo-immunotherapy administration.

Trial Locations (1)

Unknown

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

All Listed Sponsors
collaborator

Istituto Oncologico Veneto IRCCS

OTHER

collaborator

Ospedale Policlinico San Martino

OTHER

collaborator

Federico II University

OTHER

collaborator

Azienda Policlinico Umberto I

OTHER

collaborator

European Institute of Oncology

OTHER

collaborator

"Ospedale Carlo Poma - Mantova"

OTHER

collaborator

Humanitas Clinical and Research Center

OTHER

lead

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

OTHER