An open-label, randomized phase II study of the efficacy and safety of indisulam (E7070) in combination with capecitabine versus capecitabine monotherapy for the treatment of metastatic breast cancer patients following prior anthracycline and taxane therapy.

Eisai Limited0 个研究点目标入组 0 人开始时间: 2005年9月12日最近更新: 2020年4月6日

适应症

试验速览

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•Ambulant female patients aged =18 years with histologically or cytologically confirmed metastatic breast cancer who have received prior chemotherapy with an anthracycline and taxane. Patients must have completed all previous treatments (including surgery and radiotherapy) more than 4 weeks prior to treatment start and must have made a full recovery from any acute toxicities. Patients must have at least one uni-dimensionally measurable lesion according to the RECIST criteria, Karnofsky performance status of >70% and have given written informed consent.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Patients must not have received more than two chemotherapy regimens for advanced/metastatic disease or more than three regimens in total (including neo-adjuvant and adjuvant disease settings). Patients will be excluded who have any of the following laboratory parameters: hemoglobin < 10 g/dl, neutrophils < 1.5 × 10exp9/L, platelets < 100 × 10exp9/L, serum bilirubin >25 mmol/l (1.5 mg/dl); other liver parameters >2.5 x upper normal limit (ULN) (> 5 x upper normal limit in the presence of hepatic metastases); serum creatinine >1.5 x ULN; serum calcium (corrected for albumin) >11.5 mg/dl. Patients will be excluded who have progressive CNS metastases, a history of another malignancy within 5 years of study entry, significant cardiac disease, malabsorption syndrome, known hypersensitivities to sulfonamides or previous reactions to fluoropyrimidine therapy.

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