Phase III randomized trial with neoadjuvant chemotherapy (TAC) with or without zoledronic acid for patients with HER2-negative breast cancer. - NEO-ZOTAC

BOOG Study Center B.V0 个研究点开始时间: 2010年1月6日最近更新: 2012年3月19日

试验速览

暂无简介。

•Women presenting with large resectable or locally advanced breast cancer (T2 =2 cm and positive lymph nodes, T2 = 3cm? T3,T4, every N, M0)
•Measurable disease (breast and/or lymph nodes)
•Histological proven HER2-negative breast cancer in the core biopsy material.
•Age =18 years
•Adequate bone marrow function (within 14 days prior to registration): WBC =3.0 x 109/l, neutrophils =1.5 x 109/l, platelets =100 x 109/l
•Adequate liver function (within 4 weeks prior to start treatment): 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
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Evidence of distant metastases (M1)
•Prior surgery other than biopsy
•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.
•Prior bisphosphonate usage.
•Peripheral neuropathy > grade 2, whatever the cause
•Serious other diseases as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias.

发起方

BOOG Study Center B.V