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

BOOG Study Center B.V0 个研究点目标入组 250 人开始时间: 待定最近更新: 2024年5月6日

适应症

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

•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.
•Poor dental health.
•Known hypersensitivity reaction to any of the components of the treatment
•Pregnancy or lactating

发起方

BOOG Study Center B.V