Phase II study of irinotecan weekly in combination with trastuzumab in patientswith locally advanced or metastatic HER2-positive breast cancer and increased cancer cell copy number of TOP1” - POSIRI

Danish Breast Cancer Group (DBCG)0 个研究点开始时间: 2012年6月27日最近更新: 2015年12月7日

适应症

试验速览

暂无简介。

•Histological or cytological confirmed adenocarcinoma of the breast
•MBC with = 4 TOP1 genes in the primary tumour.
•Performance status 0-2
•Locally advanced or metastatic disease
•HER2 positive disease
•Measurable disease by RECIST 1.1
•Maximum 4 prior chemotherapy regiments for locally advanced or metastatic disease
•Neutrophil count (ANC) = 1,5 x 10?/l and platelet count = 100 x 10?/l
•Serum bilirubin = 1.5 x ULN
•Serum transaminases = 2.5 x ULN
•Written informed consent
•Baseline LVEF = 50% measured by echocardiography or MUGA
•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 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•Other present or previous malignancy except curatively treated
•cervical cancer stage I or non-melanotic skin cancer
•Cytotoxic or experimental treatment 2 weeks prior to inclusion
•Pregnant or breast-feeding. For fertile women a negative pregnancy
•test at screening is mandatory.
•Fertile patients not willing to use IUD as an acceptable and safe method of
•contraception
•CNS metastasis
•Allergy to the ingredients of the study medication.
•Patients who due to linguistic, culturel or incelectual reasons do not understand the protocol information
•Any condition or therapy that in the opinion of the investigator will put the patient at risk
•Patients with ongoing infections or other serious concomitant medical conditions that could interfere with the treatment.
•Dyspnoea when resting due to complications of progressive malignancy (metastasis of the lung with lymphangitis) or other conditions requiring oxygen therpy.

发起方

Danish Breast Cancer Group (DBCG)