Phase II study evaluating the toxicity and activity of the combination lapatinib + capecitabine in elderly patients aged 70 and over with metastatic breast cancer over expressing HER2

FNCLCC (Fédération Nationale des Centres de Lutte Contre le Cancer)0 个研究点开始时间: 2009年10月23日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1.Age = 70
•2.Histological confirmed advanced breast cancer (metastatic or locally advanced)
•3.Tumor over expressing HER2 (HER2 3+ in IHC or IHC 2+ and Fish positive) in sample from the primary and/or secondary tumor
•4.WHO performance status (EGOG) from 0 to 2
•5.MMS > 25
•6.Measurable disease (RECIST criteria)
•7.Progression of disease after one metastatic line of chemotherapy associated with trastuzumab (must be stopped at least 3 weeks before beginning the trial)
•8.Adequate hematological function (Hb = 9g/dl, ANC = 1500/mm3, platelets = 100 000/mm3)
•9.Adequate hepatic function (total bilirubine = 2.5 mg/dl, ASAT and ALAT = 3ULN)
•10.Adequate renal function (measured or calculated creatinine clearance = 40 ml/min - Cockroft)
•11.LVEF = 50% (US or isotopic method)
•12.Absence of treatment by enzymatic inhibitors or inducers or any gastric pH modifying agent/drug within a 7-to-14 day period preceding the first administration of one of the trial’s products and within the overall duration of the study (see medication list)
•13.Patients must be affiliated to a Social Security System
•14.Patient information and written informed consent form signed
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•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

•1.Life expectancy < 3 months
•2. Prior treatment with capecitabine or lapatinib
•3. Concomitant radiotherapy except for palliative reason and more than 25% of the BM
•4. Patients with pre-existing toxicity = grade 2 (excepted alopecia)
•5. Patients with dysphagia, or inability to swallow the capsules.
•6. Patient with malabsorption syndrome or disease significantly affecting gastro-intestinal function or with major resection of stomach or proximal bowel that could affect absorption of oral drugs
•7.Patient already included in another therapeutic trial using an experimental drug within 30 days preceding entry into the study
•8.Individual deprived of liberty or placed under the authority of a tutor
•9.Patient with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

发起方

FNCLCC (Fédération Nationale des Centres de Lutte Contre le Cancer)