Capecitabine in combination with Bendamustine in women with pretreated locally advanced or metastatic Her2-negative breast cancer, a Phase II Trial

Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH0 个研究点目标入组 40 人开始时间: 2013年5月15日最近更新: 2018年3月26日

适应症

试验速览

暂无简介。

•Signed informed consent
•Female patients, age = 18 years (women of childbearing potential must have a negative pregnancy test at screening and must use effective contraception)
•Advanced or metastatic Her2-negative breast cancer, histologically confirmed
•At least one measurable lesion according to RECIST criteria (Version 1.1)
•Documented disease progression
•Patients with progression after anthracycline and/or taxane treatment (palliative or neoadjuvant or adjuvant)
•Life expectancy of at least 12 weeks
•Performance status 0-2
•Adequate hematology, liver and renal function:
•Hematologic:
•ANC (absolute neutrophil count) = 1.5 x 109/L
•Hemoglobin = 9 g/dL
•Platelets = 100 x 109/L
•Liver Function:
•Albumin = 2.5 g/dL
•Serum bilirubin = 2 mg/dL
•AST and ALT = 3 x ULN without liver metastases
•= 5 x ULN if documented liver metastases
•Renal Function:
•Serum Creatinine = 1.5 mg/dL OR Calculated Creatinine Clearance = 40 mL/min
•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

•Pregnant or lactating women
•Serious medical or psychiatric disorders that would interfere with the patient’s safety or informed consent
•Radiation of the target lesion within the last 4 weeks
•Active bacterial, viral or fungal infection
•Patients with clinically apparent brain metastases
•Known Positivity for HIV
•Positivity for Hepatitis B or C
•History of other malignancy; patients who have been disease-free for 5 years or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
•Concurrent cancer therapy (chemotherapy, immunotherapy, antihormonal or biologic therapy) or concurrent treatment with an investigational drug
•Antihormonal therapy must have been discontinued prior to start of treatment (if possible at least 3 weeks before)
•Known hypersensitivity to the study drugs capacitabine and bendamustine or their excipients
•Pretreatment with capecitabine (pretreatment with infusional 5-FU in the adjuvant or neoadjuvant setting is allowed) or bendamustin
•Treatment with sorivudine or derivates e.g. brivudin (Mevir©) within the last 4 weeks before and during study treatment with capecitabine

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