NCT00274456已完成2 期
A Randomized Phase II Study of Weekly or Every 3 Weeks ABI-007 Versus Every 3 Weeks Taxotere as First Line Therapy of Stage IV (Metastatic) Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 302
- 试验地点
- 1
- 主要终点
- Percentage of Participants Showing an Overall Response As Assessed by the Independent Radiology Reader and by the Investigator
研究概览
简要总结
This was an open-label study conducted comparing the toxicity and antitumor activity of ABI-007 (Abraxane®, nab®-paclitaxel) to docetaxel (Taxotere).
详细描述
This was an open-label, randomized study to compare the following regimens with respect to toxicity and antitumor activity:
- the maximum tolerated dose (MTD) of ABI-007 300 mg/m^2 every 3 weeks;
- ABI-007 100 mg/m^2 administered weekly for 3 weeks with a 1 week rest;
- ABI-007 150 mg/m^2 administered weekly for 3 weeks with a 1 week rest;
- the standard dose and schedule of Taxotere (100 mg/m^2 every 3 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients had to meet the following criteria to be eligible for the study:
- •Pathologically confirmed adenocarcinoma of the breast.
- •No prior chemotherapy for metastatic breast cancer.
- •Stage IV disease.
- •Measurable disease (must have been ≥ 2.0 cm, except for pulmonary lesions that were well documented on CT scan that were ≥ 1.0 cm).
- •At least 3 weeks since prior cytotoxic chemotherapy (patients should have recovered from all acute effects of such therapy.
- •At least 4 weeks since radiotherapy, with full recovery. The measurable disease was completely outside the radiation portal or there was radiologic or clinical exam proof of progressive disease within the radiation portal.
- •At least 4 weeks since major surgery, with full recovery.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Age ≥18 years.
- •Patient had the following blood counts at Baseline:
- •Absolute neutrophil count (ANC) ≥1.5*10^9 cells/L
- •Platelets ≥100*10^9 cells/L
- •Hemoglobin (Hgb) ≥9 g/dL.
- •Patient had the following baseline blood chemistry levels:
- •Aspartate aminotransferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT])≥2.5x upper limit of normal (ULN) range
- •Total bilirubin normal
- •Alkaline phosphatase ≥2.5x ULN (unless bone metastasis is present in the absence of liver metastasis)
- •Creatinine ≥1.5 mg/dL.
- •Peripheral neuropathy Grade 0 or 1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
- •If female of childbearing potential, pregnancy test was negative (within 72 hours of the first dose of study drug).
- •If fertile, the patient agreed to use an effective method to avoid pregnancy for the duration of the study.
- •Informed consent had been obtained.
排除标准
- •Patients who met any of the following criteria were excluded from the study:
- •Prior neo-adjuvant or adjuvant chemotherapy was allowed. No prior chemotherapy for metastatic disease was allowed. If a taxane was part of the adjuvant regimen, at least one year should have transpired since completion of taxane regimen.
- •Cumulative life-time dose of doxorubicin >360 mg/m^
- •Doxorubicin was allowed as prior neo-adjuvant or adjuvant therapy but not for metastatic disease.
- •Concurrent immunotherapy or hormonal therapy for breast cancer.
- •Parenchymal brain metastases, unless documented to be clinically and radiographically stable for at least 6 months after treatment.
- •Serious intercurrent medical or psychiatric illness, including serious active infection.
- •History of class II-IV congestive heart failure.
- •History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer.
- •Patients who had received an investigational drug within the previous 3 weeks.
- •Patient was enrolled in a different clinical study in which investigational procedures were performed or investigational therapies were administered. Also, a patient was not permitted enroll in such clinical trials while participating in this study.
- •Pregnant or nursing women
- •Patients with prior hypersensitivity to either Taxol or Taxotere.
研究组 & 干预措施
ABI-007 300 mg/m^2 q3w
Experimental
ABI-007 300 mg/m^2 administered once every third week (q3w).
干预措施: ABI-007 (Drug)
ABI-007 100 mg/m^2 weekly
Experimental
ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
干预措施: ABI-007 (Drug)
ABI-007 150 mg/m^2 weekly
Experimental
ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
干预措施: ABI-007 (Drug)
Docetaxel 100 mg/m^2, q3w
Active Comparator
Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
干预措施: Docetaxel (Drug)
结局指标
主要结局
Percentage of Participants Showing an Overall Response As Assessed by the Independent Radiology Reader and by the Investigator
时间窗: Day 1 up to 95 weeks
Percentage of participants who achieve an objective confirmed complete or partial overall response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. A complete response (CR) is the disappearance of all known disease and no new sites or disease related symptoms. A partial response (PR) is \>= 30% decrease in the sum of the longest diameters of target lesion. PR was also recorded when all measurable disease has completely disappeared, but a non-measurable component (ie, ascites) is still present but not progressing. Overall response (ORR) = CR+PR.
次要结局
- Kaplan-Meier Estimates for Progression-free Survival (PFS)(Day 1 up to 95 weeks)
- Kaplan-Meier Estimates for Duration of Response Based on Independent Radiology Assessment of Response and Progression(Day 1 - 95 weeks)
- Kaplan-Meier Estimates for Duration of Response Based on Investigator Assessment of Response and Progression(Day 1 - 95 weeks)
- Percentage of Participants With Stable Disease for ≥ 16 Weeks, or Complete or Partial Overall Response(Day 1 up to 95 weeks)
- Kaplan-Meier Estimate for Overall Survival (OS)(Day 1 to 221 weeks)
- Participants With Treatment-Emergent, Treatment-Related Adverse Events(Day 1 up to 125 weeks)
研究者
研究点 (1)
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