DIetary REstriction as an adjunct to neoadjuvant ChemoTherapy for HER2 negative breast cancer - DIRECTstudy

BOOG Study Center0 个研究点目标入组 250 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•* 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

•* 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) < 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

发起方

BOOG Study Center