RecruitingPhase 2NCT05763992

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

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Enrollment

145 participants

Start Date

May 15, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Triple-Negative Breast Cancer Dietary Exposure Fasting

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial (BREAKFAST 2) is testing whether adding a fasting-like diet approach to standard chemo-immunotherapy before surgery can improve outcomes for women with triple-negative breast cancer (TNBC) — one of the most aggressive forms of breast cancer. The fasting-like approach may make cancer cells more vulnerable to treatment. **You may be eligible if...** - You are female, 18–75 years old - You have been diagnosed with triple-negative breast cancer (no estrogen, progesterone, or HER2 receptors) confirmed by biopsy - Your cancer is suitable for pre-surgery (neoadjuvant) chemo-immunotherapy followed by surgery - You are able and willing to follow a fasting-like diet regimen **You may NOT be eligible if...** - You have a history of an eating disorder or malnutrition - You have type 1 diabetes or require ongoing insulin therapy - You are pregnant or breastfeeding - You have another active cancer or severe organ problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTControl 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.

Locations(1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

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NCT05763992

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