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

Summary

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.

Conditions

• Breast Cancer
• Triple Negative Breast Cancer
• Dietary Exposure
• Fasting

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.

Sponsors & Collaborators

• Istituto Oncologico Veneto IRCCS

  collaborator OTHER

• Ospedale Policlinico San Martino

  collaborator OTHER

• Federico II University

  collaborator OTHER

• Azienda Policlinico Umberto I

  collaborator OTHER

• European Institute of Oncology

  collaborator OTHER

• Ospedale "Carlo Poma" - Mantova

  collaborator OTHER

• Humanitas Clinical and Research Center

  collaborator OTHER

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  lead OTHER

Principal Investigators

• Maria Vittoria Dieci, MD · Istituto Oncologico Veneto, Via Gattamelata 64, 35128 Padova, Italy

• Matteo Lambertini, MD · IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 16132 Genova

• Sabino De Placido, MD · University of Naples Federico II, Via Sergio Pansini 5, 80131 Naples

• Monica Iorfida, MD · Istituto Europeo di Oncologia

• Alberto Zambelli, MD · Humanitas Research Hospital, Via Alessandro Manzoni 56, 20089 Rozzano

• Andrea Botticelli, MD · "Sapienza" University of Rome, 00185, Rome

• Carla Strina, MD · A.O. "Istituti Ospitalieri", Viale Concordia 1, 26100 Cremona

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

2023-05-15

Primary Completion

2025-05-15

Completion

2026-05-15

Countries

• Italy

Study Locations