A RANDOMIZED, PHASE 3 STUDY OF SUNITINIB IN COMBINATION WITH CAPECITABINE COMPARED WITH CAPECITABINE IN PATIENTS WITH PREVIOUSLY TREATED BREAST CANCER.

Pfizer, S.L.U.0 个研究点目标入组 430 人开始时间: 2012年3月15日最近更新: 2012年9月3日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 430

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Histologically or cytologically proven diagnosis of breast adenocarcinoma with evidence of locally advanced or metastatic disease not amenable to surgery or radiation therapy with curative intent.
•2. Measurable disease as per RECIST or bone-only disease. (Enrollment of patients having bone-only disease is at the discretion of Principal Investigators and Institutional Review Boards/Ethics Committees at participating institutions. Patients having bone-only disease will be required to undergo an additional bone scan 6 weeks after randomization).
•3. Prior treatment with an anthracycline and a taxane in the neoadjuvant, adjuvant or metastatic disease setting
•4. Candidate for treatment with capecitabine not contraindicated according to the local standard of care.
•5. Prior treatment with chemotherapy as follows:
•? Receipt of neoadjuvant or adjuvant chemotherapy with RECIST or World Health Organization (WHO)-defined disease progression documented during treatment or disease relapse within 12 months of last treatment with chemotherapy, OR
•? Receipt of chemotherapy in the first or second-line advanced disease setting with RECIST or WHO-defined disease progression documented during or, following treatment. Patients entering the study on the basis of this criterion may have also previously received neoadjuvant or adjuvant treatment with chemotherapy.
•6. Prior treatment with hormonal therapy as follows:
•? Hormonal therapy concurrent or sequential to adjuvant chemotherapy is allowed.
•? Patients that have bone-only disease who are hormone receptor-positive must have progressed during or after hormone-therapy to be eligible
•? Hormonal therapy for advanced disease is allowed but must be discontinued prior to the start of study treatment.
•7. Patients with HER2 positive disease (ie, FISH or CISH (where approved) positive or immunohistochemistry +3) may enter the study provided that they have previously received treatment with trastuzumab and where it is recommended as community standard of care, lapatinib in the adjuvant or advanced disease setting. Prior treatment with lapatinib is not mandatory. Patients may have discontinued trastuzumab and/or lapatinib for reasons other than progression (eg toxicity or lack of clinical benefit).
•8. May have received prior radiation therapy. A measurable lesion that has been previously irradiated will be evaluated only when it increases in size. Radiotherapy is to be completed prior to screening disease assessments.
•9. Female or male, 18 years of age or older.
•10. ECOG performance status 0 or 1.
•11. Resolution of all acute toxic effects of prior therapy or surgical procedures to grade minor or equal 1 except alopecia or other toxicities not considered a safety risk for the patient.
•12. Adequate organ function as defined by the following criteria:
•? Serum aspartate transaminase (AST) minor or equal 2.5 x upper limit of normal (ULN) or minor or equal 5 x ULN if liver function abnormalities are due to underlying malignancy.
•? Total serum bilirubin <1.5 x ULN regardless of liver involvement secondary to tumor. (Patients with Gilbert?s disease may not be required to meet this criterion.)
•? Serum albumin ?2.5 g/dL
•? Serum creatinine minor or equal 1.5 x ULN
•? Creatinine clearance ?50 mL/min
•? Absolute neutrophil count (ANC) ?1500/?L
•? Platelets ?100,000/?L
•? Hemoglobin ?8.5 g/dL
•? Left ventricular ejection fraction (LVEF) ?50% as measured by either multigated acquisition (MUGA) scan or echocardiogram (ECH

排除标准

•1. Histology of inflammatory carcinoma with no other measurable disease. Patients with histology of inflammatory carcinoma are allowed on study if they have measurable disease.
•2. Prior treatment with ?3 chemotherapy regimens in the advanced disease setting.
•3. Prior treatment with capecitabine or sunitinib.
•4. Known hypersensitivity to 5-fluorouracil.
•5. Known dihydropyrimidine dehydrogenase deficiency.
•6. Major surgery or systemic therapy (except hormone therapy) within 3 weeks of the start of study treatment. At least 1 week should elapse since minor surgical procedure including placement of an access device.
•7. Deleted per Amendment #5 (Prior high-dose chemotherapy requiring hematopoietic stem cell rescue).
•8. Deleted per Amendment #5 (Prior radiation therapy to >25% of the bone marrow [whole pelvis is 25%]).
•9. Current treatment on another clinical trial.
•10. Brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.
•11. Diagnosis of any second malignancy within the last 3 years, except for a previous breast cancer or adequately treated basal cell carcinoma or squamous cell skin cancer or in situ carcinoma of the cervix uteri.
•12. Any of the following within the 6 months prior to starting study treatment: myocardial infarction, severe/unstable angina, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus.
•13. Ongoing cardiac dysrhythmias of NCI CTCAE grade ?2, or QTc interval >470 msec for females or >450 msec for males.
•14. Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy).
•15. Current treatment with therapeutic doses of coumarin-derivatives such as warfarin and phenprocoumon (use of low dose for deep vein thrombosis prophylaxis is allowed) or oral anti-vitamin K agents. If currently receiving treatment with oral coumarin-derivatives, patients must have their PT or INR monitored. Low molecular weight heparin is allowed at any dose level.
•16. Known human immunodeficiency virus infection.
•17. Female who is pregnant or nursing; female of child-bearing potential who is unwilling or unable to use adequate contraception to prevent pregnancy during the study and for 3 months after the last dose of study treatment. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to randomization.
•18. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

研究者

发起方

Pfizer, S.L.U.

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