NCT00607438终止2 期
A Phase II Study Of Abraxane and Nexavar in the First-Line Treatment of Locally Advanced or Metastatic Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- To evaluate the progression-free survival (PFS)and duration of response of the combination of weekly Abraxane and continuous Nexavar as first-line treatment for patients with locally advanced or metastatic breast cancer.
研究概览
简要总结
This is a Phase II, open-label, non-randomized study in patients with locally advanced or metastatic breast cancer.
Each cycle will be 4 weeks in length. Patients will receive Abraxane weekly for 3 weeks. Patients will not receive Abraxane during week 4 (rest week). Nexavar will be given continuously.
Patients will be radiologically evaluated every 8 weeks for response. Patients will continue to receive study treatment until disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have signed an IRB-approved informed consent.
- •Patients must have histologically confirmed locally advanced or metastatic breast cancer.
- •Patients must be HER2-negative.
- •Patients must have measurable disease, as defined by the RECIST criteria.
- •Patients may have received prior adjuvant chemotherapy for breast cancer, including taxane-containing regimens, provided this treatment was completed at least 12 months prior to enrollment.
- •Patients must be <18 years of age.
- •Patients must have an ECOG Performance Status of 0 or
- •Patients' estimated life expectancy must be at least 12 weeks.
- •Patients must have adequate liver functions defined as: total bilirubin within normal limits and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 X upper limit of normal (ULN) (or < 5 X ULN for patients with liver involvement).
- •Patients must have alkaline phosphatase ≤ 2.5 X ULN. Alkaline phosphatase may be > 2.5 x ULN if bone metastasis is present in the absence of liver metastasis, and the patient's bilirubin ≤ ULN.
- •Patients must have adequate renal function defined as: creatinine ≤ 1.5 mg/dL.
- •Patients must have adequate bone marrow function, including absolute neutrophil count (ANC) >1500/µL, platelet count >100,000/µL, and hemoglobin >9 g/dL.
- •Patients must have a normal baseline left ventricular ejection fraction (LVEF).
- •Patients must be normotensive. Patients taking anti-hypertensive medication must have blood pressure controlled and not greater than 140/
- •International Normalized Ratio (INR) < 1.5 or a prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits.
- •Patients must either be not of child bearing potential or have a negative serum pregnancy test within 7 days prior to registration. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or they are postmenopausal for at least 12 months.
- •Patients of childbearing potential must agree to use effective contraceptive measures during study treatment and for a reasonable time thereafter.
- •Patients must be willing and able to comply with scheduled visits, treatment plan and laboratory testing, and be accessible for follow-up.
排除标准
- •Patients who have received prior chemotherapy for the treatment of locally advanced or metastatic breast cancer.
- •Patients who have received prior Abraxane or Nexavar.
- •Patients who have a history of hypersensitivity or a suspected allergy to taxanes, any of the components in taxanes, Abraxane, or Nexavar.
- •Patients with serious intercurrent medical or psychiatric illness, including serious active infection.
- •Patients with untreated or active brain metastases. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
- •Patients with a history of thrombosis.
- •Patients with thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
- •Patients with symptomatic congestive heart failure or a baseline echocardiogram with LVEF < ULN.
- •Patients with congestive heart failure > class II New York Heart Association (NYHA). Patients must not have unstable angina (anginal symptoms at rest), or new onset angina (began within the last 3 months), or myocardial infarction within the past 6 months.
- •Patients with cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
- •Patients with a history of, or active, bowel perforation or inflammatory bowel disease.
- •Patients with active peptic ulcer disease or symptoms to suggest possible ulcer (discontinuation of chronic NSAID therapy advised, or if not possible, use of proton-pump inhibitors recommended.)
- •Patients planning to receive any concurrent therapy to treat locally advanced or metastatic breast cancer during the study treatment period.
- •Any patient who is pregnant or lactating.
- •Patients with proteinuria > +1 by baseline dipstick, or if +2, 24-hour urine total protein > 250 mg.
- •Patients who have undergone major surgery, open biopsy, or significant traumatic injury within 28 days, or minor surgery within 14 days. (The placement of a Mediport or other vascular access device is permitted if performed at least 7 days prior to registration).
- •Patients with > Grade 2 peripheral neuropathy (NCI-CTC v3.0) or any painful neuropathy.
- •Patients who have experienced any type of bone fracture within 12 months or who have undergone joint replacement surgery within 6 months.
- •Patients with a serious non-healing wound.
- •Patients with known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
- •Patients requiring anticoagulants (with the exception of low-dose Coumadin, ASA, Plavix or Heparin for maintenance of vascular access patency).
- •Patients with evidence or history of bleeding diathesis or coagulopathy.
- •Patients experiencing any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug.
- •Patients with pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug.
- •Patients with any condition that impairs a patient's ability to swallow whole pills or patients with any malabsorption problems.
- •Patients who use St. John's Wort or rifampin (rifampicin).
结局指标
主要结局
To evaluate the progression-free survival (PFS)and duration of response of the combination of weekly Abraxane and continuous Nexavar as first-line treatment for patients with locally advanced or metastatic breast cancer.
时间窗: Survival every 3 months for two years starting from the end of study date. Duration of response every 8 weeks while on treatment.
次要结局
- To evaluate the response rate.(Every 8 weeks while on study treatment.)
- Evaluate the 1 and 2 year survival rate.(Every 3 months for 2 years starting from the end of therapy visit date)
- Evaluate the toxicities of the combination of Abraxane and Nexavar(At each clinic visit or if reported by subject.)
研究者
研究点 (2)
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