Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Leiden University Medical Center
With
Borstkanker Onderzoek Groep
Pink Ribbon Inc.
Amgen
Age
18–70
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | DIetary REstriction as an Adjunct to Neoadjuvant ChemoTherapy for HER2 Negative Breast Cancer
