Breast cancer mamma carcinoma
Conditions
Interventions
Chemolieve* for 3 days prior to and the day of chemotherapy and 3 days prior to
surgery versus regular diet.
Sponsors
BOOG Study Center
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Female patients with stage II or III breast cancer receiving neoadjuvant 4AC>4T or 3FEC>3T * 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 10^9/l, platelets *100 x 10^9/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
Exclusion criteria: * History of invasive breast cancer or ipsilateral non-invasive breast cancer * 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * The percentage of patients with grade III/IV toxicity to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (phase II). * The percentage of pathological complete response according Miller and Payne (phase III). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: * To determine the effect of FMD on the clinical response measured by MRI (RECIST1.1) halfway therapy. * To determine the effect of FMD on grade I/II side effects of chemotherapy according to NCI CTCAE v4.03. * Metabolic (Glucose, insulin, insulin-like growth factor-I (IGF-I), insulin-like growth factor binding protein 3 (IGF-BP3), free thyroxin (FT4), T3 and thyroid-stimulating hormone (TSH)) and inflammatory response (CRP) to chemotherapy. * DNA damage, apoptosis, immunology and nutrient sensing system activity in the tumor. * Patient*s quality of life (using EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires), burden of therapy noted by a visual analogue scale (VAS) (Distress Thermometer) and differences of Illness Perceptions (B-IPQ). * Long term efficacy of treatment (DFS, OS). * Hormone receptor percentage, Ki67 and immunologic tumor profile and tumor/stroma ratio as predictive biomarker. * SNPs used as biomarker to predict treatment outcome. Side study endpoints: * Protein profiles and cytokines used as biomarker to predict treatment outcome * Quantification of chemotherapy-induced DNA damage in leukocytes (with *-H2AX modification and comet assay). * Quantification of nutrient sensing system gene expression (with western blot). | — |
Countries
Netherlands
Outcome results
None listed