EUCTR2006-004624-36-BE进行中（未招募）1 期
A RANDOMIZED, PHASE 3 STUDY OF SUNITINIB IN COMBINATION WITH CAPECITABINE COMPARED WITH CAPECITABINE IN PATIENTS WITH PREVIOUSLY TREATED BREAST CANCER
Pfizer Inc - 235 East 42nd Street, New York, NY 100170 个研究点目标入组 430 人开始时间: 2007年1月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 430
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
- •Patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
- •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 =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) =2.5 x upper limit of normal (ULN) or =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 =1.5 x ULN
- •Creatinine clearance =50 mL/min
- •Absolute neutrophil count (ANC) =1500/µL
- •Platelets =100,000/µL
- •Hemoglobin =8.5 g/dL
- •Left ventricular ejection fraction (LVEF) =50% as measured by either multigated
- •acquisition (M
排除标准
- •Patients presenting with any of the following will not be included in the trial:
- •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
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