Actively Recruiting
Targeting Triple Negative BREAst Cancer Metabolism With a Combination of Chemoimmunotherapy and a FASTing-like Approach in the Preoperative Setting: the BREAKFAST 2 Trial
Led by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Updated on 2023-05-18
145
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
F
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Lead Sponsor
I
Istituto Oncologico Veneto IRCCS
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Targeting Triple Negative BREAst Cancer Metabolism With a Combination of Chemoimmunotherapy and a FASTing-like Approach in the Preoperative Setting: the BREAKFAST 2 Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female sex
- Age between 18 and 75 years
- Signed informed consent before enrollment
- Willingness and ability to follow the FLA diet, scheduled visits, treatments, and tests
- Histologically confirmed invasive Triple Negative Breast Cancer (HER2 negative, ER <1%, PgR <1%) eligible for neoadjuvant chemo-immunotherapy and surgery
- Availability of tumor tissue samples for analysis
- Tumor stage T1c with nodal stage N1-2, or tumor stage T2-4 with nodal stage N0-2
- ECOG performance status 0 or 1
- Adequate bone marrow and organ function based on specified laboratory values
- Agreement to use effective contraception or sexual abstinence during the study and for 6 months after if of childbearing potential
- Female patients not of childbearing potential if post-menopausal, surgically sterile, or with confirmed ovarian failure
You will not qualify if you...
- Prior systemic treatment for breast cancer or other cancers within 5 years, except certain skin or cervical cancers
- Prior anthracycline treatment
- Previous therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or other immune checkpoint inhibitors
- Body mass index less than 19 kg/m2
- History of alcohol abuse
- Recent significant unintentional weight loss
- Active pregnancy or breastfeeding
- Active hepatitis B or C infection, HIV infection, or requiring treatment for these
- Serious infections within 4 weeks before starting FLA
- Active autoimmune diseases requiring systemic treatment
- Chronic systemic steroid therapy at or above 10 mg prednisone daily
- Diabetes requiring pharmacological treatment except metformin
- Significant heart disease or cardiac arrhythmias
- Left ventricular ejection fraction below 50%
- Previous episodes of symptomatic hypotension with loss of consciousness
- History of eating disorders
- Fasting plasma glucose below 60 mg/dL
- Medical or psychiatric conditions making trial participation unsafe
- Other serious cardiac, liver, lung, or kidney diseases with risk of lactic acidosis
- Known active tuberculosis infection
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
Actively Recruiting
Research Team
C
Claudio Vernieri, MD, PhD
CONTACT
F
Francesca Ligorio, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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