A phase II, single-centre, randomised 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

nited Lincolnshire Hospitals NHS Trust (UK)0 个研究点目标入组 130 人开始时间: 2011年5月20日最近更新: 2018年2月26日

适应症

试验速览

•1. Women with histologically confirmed carcinoma of the breast, with measurable or evaluable large (greater than or equal to 3 cm) or locally advanced (T3, T4, TxN2) disease
•2. Women who are over 18 and under 75 years and able to sign the informed consent

•1. World Health Organisation (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:
•6.1. Absolute neutrophil count < 1500/uL
•6.2. Platelet count < 100,000/uL
•6.3. Total bilirubin > 1.5 mg/dL
•6.4. Alkaline phosphatase, AST, and/or ALT > 2x upper limit of normal
•6.5. Serum creatinine > 2.0 mg/dL
•6.6. Urine protein/creatinine ratio > 1.0 at screening
•7. Inability to complete Quality of Life questionnaires
•8. Contraindications for modified radical mastectomy (MRM), including contrast media safety, are as for standard magnetic resonance imaging (MRI)

发起方

nited Lincolnshire Hospitals NHS Trust (UK)