Prospective evaluation of the predictive value of a circulating tumor cell (CTC) sensitivity profile to Cisplatin chemotherapy in metastatic breast cancer patients - CTC-cDDP

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 67 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

Trial is onging in other countries

•* Female patient with metastatic breast cancer who has been pretreated with at least anthracycline and taxane-based chemotherapy in the adjuvant and/or metastatic setting ;* Measurable disease according to RECIST 1.1, ie at least one measurable lesion on CT-scan where the longest diameter in the plane of measurement is a minimum size of 10mm;* Age * 18 years;* WHO performance status *2;* Adequate hematological functions defined as ANC * 1.0 x 109/L, platelets * 100 x 109/L;* Adequate renal function defined as creatinin clearance * 60 mL/min (Cockcroft Gault);* Patients with reproductive potential must use a reliable method of contraception;* Written informed consent

•* Other anticancer chemotherapy, use of biological response modifiers, or immunotherapy within two weeks prior to treatment start. Hormonal antitumor treatment within one week prior to treatment start. ;* Hearing loss of at least Common Terminology Criteria for Adverse Events (CTCAE) grade 2;* Neuropathy of at least CTCAE grade 2;* Pregnant or lactating patients;* Serious illness or medical unstable condition prohibiting adequate treatment and follow-up ;* Symptomatic CNS metastases (the presence of at least one key symptom in combination with radiologic evidence (positive contrast-enhanced CT or MRI of the brain));* History of psychiatric disorder that would prohibit the understanding and giving of informed consent or that would prohibit adequate follow-up

发起方