DIetary REstriction as an Adjunct to Neoadjuvant ChemoTherapy for HER2 Negative Breast Cancer

Inclusion criteria

• Female patients with stage II or III (cT1cN+ or ≥T2 any cN, cM0) breast cancer receiving neoadjuvant AC-T
• Measurable disease (breast and/or lymph nodes)
• HER2 negative core biopsy Age ≥18 years
• WHO performance status 0-2
• Adequate bone marrow function : white blood cells (WBCs) ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l
• Adequate liver function: bilirubin ≤1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤2.5 x UNL, Alkaline Phosphatase ≤5 x UNL
• Adequate renal function: the calculated creatinine clearance should be ≥50 mL/min
• Patients must be accessible for treatment and follow-up
• Written informed consent according to the local Ethics Committee requirements
• Willing to fill in quality of life questionnaires
• Able to read and write in Dutch

Exclusion criteria

• History of breast cancer (invasive or non-invasive)
• Previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix.
• Serious other diseases such as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias
• Diabetes Mellitus
• Body mass index (BMI) < 19 kg/m2
• Pregnancy or lactating
• Significant food allergies which would make the subject unable to consume the food provided (ex: nuts or soy)
• Any metabolic disorders that may affect gluconeogenesis or adaptation to short fasting periods.
• Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent