EUCTR2005-003774-15-DE进行中（未招募）不适用
A RANDOMIZED PHASE 2 STUDY OF SU011248 VERSUS STANDARD-OF-CARE FOR PATIENTS WITH PREVIOUSLY TREATED, ADVANCED, TRIPLE RECEPTOR NEGATIVE (ER, PR, AND HER2) BREAST CANCER
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
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 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
- •2. Documentation of estrogen and progestin receptor (ER/PR) negative status and
- •HER2/neu receptor negative status (ie, FISH or Cish (where approved) negative
- •or immunohistochemistry 0 or +1).
- •3. Prior treatment with an anthracycline and a taxane in the neoadjuvant, adjuvant
- •or metastatic disease setting.
- •4. Prior treatment with chemotherapy as follows:
- •Receipt of adjuvant chemotherapy with RECIST or World Health Organization
- •(WHO)-defined disease progression documented during treatment or disease
- •relapse within 6 months of last treatment, OR
- •Receipt of chemotherapy in the first-line advanced disease setting with RECIST
- •or WHO-defined disease progression documented during treatment, or, if the
- •patient completed treatment with objective disease response, documented
- •disease progression after discontinuing treatment.
- •Patients entering the study on the basis of this criterion may have also
- •previously received neoadjuvant or adjuvant treatment with chemotherapy.
- •5. Measurable disease as per RECIST. Measurable lesions that have been
- •previously radiated will not be considered target lesions unless increase in size
- •has been observed following completion of radiation therapy.
- •6. Candidate for treatment with one of the standard chemotherapy regimens
- •listed if patient is randomized to the control arm. Safety precautions standard
- •for specific chemotherapy regimens but not stated in study entry criteria must
- •be ensured by the investigator prior to randomization. Examples include
- •precautions for some chemotherapy regimens based on moderately elevated
- •liver function tests and prior hypersensitivity to an agent.
- •7. Patients receiving bisphosphonate therapy for metastatic bone disease must
- •have initiated therapy at least 3 weeks prior to first dose of treatment on study.
- •8. Male or female, 18 years of age or older.
- •9. ECOG performance status 0 or 1.
- •10. Resolution of all acute toxic effects of prior therapy or surgical procedures to
- •grade less tha/equal to 1 (except alopecia).
- •11. The definitions of minimum adequacy for organ function required prior to study
- •entry are as follows. In addition, safety precautions provided in the product
- •labeling for the anticipated control arm chemotherapy must be observed.
- •Serum aspartate transaminase (AST) and serum alanine transaminase
- •(ALT) less than/equal to 2.5 x upper limit of normal (ULN), or AST and ALT less
- •than/equal to 5 x ULN if liver function abnormalities are due to underlying
- •Total serum bilirubin less than/equal to 1.5 x ULN
- •Serum albumin major than/equal to 3.0 g/dL
- •Absolute neutrophil count (ANC) major than/equal to 1500/microL
- •Platelets major than/equal to 100,000/microL
- •Hemoglobin major than/equal to 9.0 g/dL
- •Serum creatinine less than/equal to 1.5 x ULN
- •12. 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 t
排除标准
- •1. Histology of inflammatory carcinoma.
- •2. Prior treatment with omore than/ equal to 2 regimens of cytotoxic therapy in the advanced disease
- •3. Prior treatment on a SU011248 clinical trial.
- •4. Exclusion criterion 4 deleted by Protocol Amendment 1.
- •5. Major surgery, radiation therapy, or systemic therapy within 3 weeks of study
- •randomization except palliative radiotherapy to non-target metastatic lesions.
- •6. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.
- •7. Prior radiation therapy to >25% of the bone marrow.
- •8. Current treatment on another clinical trial.
- •9. Uncontrolled brain metastases, spinal cord compression, carcinomatous
- •meningitis, or leptomeningeal disease. Patients should have completed surgery
- •or radiation therapy for existing brain metastases, should not have documented
- •increase in size over the previous 3 months prior to first dose of treatment on
- •study and should be asymptomatic.
- •10. Diagnosis of any second malignancy within the last 3 years, except for
- •adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
- •of the cervix.
- •11. Any of the following within the 12 months prior to starting study treatment:
- •myocardial infarction, severe/unstable angina, coronary/peripheral artery
- •bypass graft, congestive heart failure, cerebrovascular accident including
- •transient ischemic attack, or pulmonary embolus.
- •12. Ongoing cardiac dysrhythmias of NCI CTCAE grade major than/equal to 2, atrial
- •fibrillation of any grade, or QTc interval >470 msec
- •13. Hypertension that cannot be controlled by medications (>150/100 mmHg
- •despite optimal medical therapy).
- •14. Current treatment with therapeutic doses of Coumadin (low dose Coumadin up
- •to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
- •15. Known human immunodeficiency virus infection.
- •16. Pregnancy or breastfeeding. All female patients with reproductive potential
- •must have a negative pregnancy test (serum or urine) prior to randomization.
- •17. 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
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