Phase II study of the effectiveness of the addition of Capecitabine to a standard regimen containing Adriamycin, Cyclophosphamide and Docetaxel as neoadjuvant treatment in large or locally advanced breast cancers (XINACT) - NAC breast cancer: docetaxel capecitabine

nited Lincolnshire Hospitals NHS Trust0 个研究点目标入组 120 人开始时间: 2007年7月31日最近更新: 2012年3月19日

试验速览

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•1. Women with histologically confirmed carcinoma of the breast, with measurable or evaluable large (= 3cm) or locally advanced (T3, T4, TxN2) disease
•2. Women who are over 18 and under 75 years and able to sign the informed consent
•3. Ability to comply with study and follow-up procedures
•4. Adequate left ventricular function at study entry, defined as LVEF = 50% by echocardiography (ECHO)
•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 90
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 25

•1. WHO performance status 2, 3 and 4
•2. Prior chemotherapy or radiotherapy unless for basal cell carcinoma
•3. Unstable angina and/or evidence of significant cardiac dysfunction
•4. Patients who have diabetes requiring insulin
•5. Pregnancy or lactation
•6. Inadequate organ function, as evidenced by any of the following laboratory values: Absolute neutrophil count < 1500/uL; Platelet count < 100,000/uL; Total bilirubin > 1.5 mg/dL; Alkaline phosphatase, AST, and/or ALT > 2x upper limit of normal; Serum creatinine > 2.0 mg/dL; PTT and/or either INR or PT > 1.5x upper limit of normal (except for subjects receiving anti-coagulation therapy); Urine protein/creatinine ratio > 1.0 at screening
•7. Inability to complete Quality of Life questionnaires

发起方

nited Lincolnshire Hospitals NHS Trust