Explorative trial to identify the impact of denosumab on the systemic immunity and local immunologic microenvironment in postmenopausal patients with HER2 negative breast cancer. - PERIDENO study

BOOG Study Center0 个研究点目标入组 75 人开始时间: 2017年12月21日最近更新: 2019年2月28日

适应症

试验速览

暂无简介。

•Postmenopausal, defined as 1 year without menstrual activity, previous bilateral oophorectomy, age older than 60 years or baseline FSH >20 U/l and estradiol <110 pmol/l.
•Clinical stage T1c + grade 3/4, stage II or III breast cancer amenable to adjuvant AC-T or ddAC-T combination chemotherapy.
•Measurable disease (breast and/or lymph nodes)
•Histological proven HER2-negative breast cancer in the core biopsy material.
•Adequate bone marrow function (within 4 weeks prior to randomization): WBC=3.0x10^9/l, neutrophils =1.5 x 10^9/l, platelets =100 x 10^9/l
•Adequate liver function (within 4 weeks prior to randomization): 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 (within 4 weeks prior to randomization): the calculated creatinine clearance should be =50 ml/min
•Albumin-adjusted serum calcium > 2.0 mmol/L (8.0mg/dL)
•Accessible for treatment and follow-up
•Written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 37
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 38

•Evidence of distant metastases (M1)
•History of invasive breast cancer
•Prior chemotherapy or radiation therapy
•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 as recent (last 6 months) myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias.
•Prior or current bisphosphonate or denosumab usage.
•Osteoporosis as demonstrated on dexa vfa scan, defined as T = 2.5 and/or a vertebral fracture.
•Current active dental problems including dental abscess or infection of the jawbone (maxilla or mandible), non-healed dental or oral surgery, a current or prior diagnosis of osteonecrosis of the jaw or planned invasive dental procedures for the course of the study.
•Known hypersensitivity reaction to any of the components of the treatment
•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