A prospective, Belgian multi-center, single-arm, phase II study of neoadjuvant weekly paclitaxel and carboplatin followed by dose dense epirubicin and cyclophosphamide in stage II and III triple negative breast cancer.

Belgian Society of Medical Oncology0 个研究点目标入组 63 人开始时间: 2015年2月6日最近更新: 2022年3月28日

适应症

试验速览

暂无简介。

•-Stage II-III operable triple negative (ER and PR < 10%; Her2 IHC 0-1 or FISH <2.0) breast cancer in women age > 18. For patients aged 65 or older the G8 geriatric screening test should be > 14 (on a total of 17).
•-Baseline mammography, US. MR of the breast on clinical indication.
•-FNA of suspicious axillary lymph node is indicated
•-Pre-treatment SN biopsy is indicated in clinical N0
•-Measurable loco-regional disease
•-Adequate bone marrow function, defined as
•oAbsolute neutrophil count(ANC) >1500*109/L
•oPlatelet count >100.000*109/L
•-Adequate liver function defined as
•oSerum(total) bilirubin <1.5*upper limit of normal(ULN), unless the patient has documented Gilbert’s Syndrome
•oAST and/or ALT <2.5*ULN
•oAlkaline phosphatase <2.5*ULN
•-Normal cardiac function measured by ultrasound with a left ventricular function > 55%
•-Creatinine clearance > 40 ml/min according to local laboratory standard (MDRD, CDK-epi, Cockroft-Gault, or other established formula to calculate renal function)
•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 63
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 63

•- T4d breast tumor
•- Bilateral breast cancer
•- Other invasive cancer in the past except for a localized squamous cell cancer or basal cell of the skin or an in situ squamous cell cancer of the cervix.

发起方

Belgian Society of Medical Oncology