EUCTR2006-004693-27-BE进行中（未招募）不适用
A RANDOMISED, PHASE 3 STUDY OF DOCETAXEL IN COMBINATION WITH SUNITINIB VERSUS DOCETAXEL IN THE FIRST-LINE TREATMENT OF ADVANCED BREAST CANCER PATIENTS
Pfizer Inc - 235 East 42nd Street, New York, NY 100170 个研究点目标入组 550 人开始时间: 2006年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 550
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
- Female
入选标准
- •1. Histologically or cytologically proven diagnosis of breast cancer with evidence of
- •1) unresectable, locally recurrent, or 2) metastatic disease. Locally recurrent
- •disease must not be amenable to resection or radiation therapy with curative intent.
- •2. Her-2 negative breast cancer (i.e., FISH or CISH (where approved) negative or
- •immunohistochemistry 0 or +1).
- •3. Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST)
- •or bone-only disease.
- •4. The following patients are eligible:
- •Patients not candidate for adjuvant chemotherapy at first diagnosis who
- •relapsed with distant metastases
- •Patients candidate for adjuvant or neo-adjuvant hormonal therapy at first
- •diagnosis who relapsed with distant metastases.
- •Patients candidate for adjuvant or neo-adjuvant cytotoxic therapy at first
- •diagnosis who relapsed with locally advanced or metastatic disease
- •If adjuvant or neo-adjuvant therapy included also a taxane, relapse
- •must have occurred =12 months since completion of chemotherapy.
- •Hormonal therapy concurrent or sequential to adjuvant chemotherapy
- •is allowed.
- •Hormonal therapy for advanced disease is allowed but is to be discontinued
- •prior to the start of study treatment.
- •Patients with bone-only disease that are hormone receptor-positive must have
- •progressed during or after hormone therapy prior to entering the trial.
- •5. Must be candidate for treatment with docetaxel.
- •6. 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.
- •7. Female, 18 years of age or older.
- •8. ECOG performance status 0 or 1.
- •9. 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).
- •10. Adequate organ function as defined by the following criteria:
- •Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) =1.5
- •x upper limit of normal (ULN), or AST and ALT =2.5 x ULN if liver function
- •abnormalities are due to underlying malignancy.
- •Deleted in Amendment 2 (Alkaline phosphatase (ALP) =2.5 x ULN).
- •Total serum bilirubin <1 x ULN. [patients suffering from Gilbert’s disease are
- •allowed to enter the study]
- •Serum albumin =2.5 g/dL.
- •Absolute neutrophil count (ANC) =1500/µL.
- •Platelets =100,000/µL.
- •Hemoglobin =8.5 g/dL.
- •Serum creatinine =1.5 x ULN.
- •Left ventricular ejection fraction (LVEF) =50% as measured by either multigated
- •acquisition (MUGA) scan or echocardiogram (ECHO).
- •11. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
- •12. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- •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
- 另有 2 项未显示
排除标准
- •1. Clinical presentation of inflammatory carcinoma with no other measurable disease.
- •2. Prior treatment with chemotherapy in the metastatic disease setting.
- •3.Prior treatment on a sunitinib clinical trial.
- •4. Patients for whom docetaxel is contraindicated according to the local prescribing
- •information.
- •5. History of severe hypersensitivity reactions to docetaxel or to other drugs
- •formulated with polysorbate 80.
- •6. AST and/or ALT >1.5 x ULN concomitant with ALP >2.5 x ULN.
- •7. Major surgery, or systemic therapy (with the exception of hormonal therapy) within
- •3 weeks of start of study treatment. At least 1 week should elapse since minor
- •surgical procedures including placement of an access device or fine needle
- •aspiration.
- •8. Deleted in Amendment 2 (Prior high-dose chemotherapy requiring hematopoietic
- •stem cell rescue).
- •9. Deleted in Amendment 2 (Prior radiation therapy to >25% of the bone marrow).
- •10. Current treatment on another clinical trial.
- •11. History or presence of brain metastases, presence of spinal cord compression, or
- •carcinomatous meningitis, or leptomeningeal disease.
- •12. Diagnosis of any second malignancy within the last 3 years, except for adequately
- •treated basal cell carcinoma or squamous cell skin cancer or in situ carcinoma of
- •the cervix uteri.
- •13. 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
- •14. Ongoing cardiac dysrhythmias of grade =2, or QTc interval >470 msec.
- •15. Hypertension that cannot be controlled by medications (>150/100 mmHg despite
- •optimal medical therapy).
- •16. Current treatment with therapeutic doses of coumarin derivatives such as warfarin and phenprocoumon (low dose for deep vein thrombosis prophylaxis is allowed) or oral anti-vitamin K agents. Treatment with therapeutic doses of low-molecularweight heparin is allowed.
- •17. Known human immunodeficiency virus infection.
- •18. Pregnancy or breastfeeding. Female patients who are pregnant or nursing, female of child-bearing potential who is unwilling or unable to use adequate contraception to prevent pregnancy during the trial 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 study entry.
- •19. 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. Prior treatment on a sunitinib clinical trial.
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