A Phase II Study of Weekly Dose-Dense Nanoparticle Paclitaxel (ABI-007), Carboplatin With Herceptin® As First-Line Therapy of Advanced HER-2 Positive Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 32
- 试验地点
- 14
- 主要终点
- Percentage of Participants Who Achieved an Objective Confirmed Complete or Partial Overall Response
研究概览
简要总结
This trial will treat patients with advanced breast cancer with a new anti-cancer medicine used in combination with two existing anti-cancer medications: Albumin-bound paclitaxel (ABI-007), Carboplatin and Herceptin. Participants will be given the combination therapy on a weekly basis and may continue on therapy as long as their condition improves and drug toxicity is tolerated.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Confirmed adenocarcinoma of the breast
- •Tumor shows 3+ overexpression of the human epidermal growth factor receptor 2 (HER-2)/proto-oncogene by immunohistochemistry assay, or is fluorescence in situ hybridization (FISH)+
- •Stage IV disease
- •Measurable disease
- •At least 3 weeks since prior cytotoxic chemotherapy
- •At least 4 weeks since radiotherapy with full recovery
- •At least 4 weeks since major surgery with full recovery
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •At least 18 years old
- •Absolute neutrophil count (ANC) at least 1.5 x 10^9 cells/L
- •Platelets at least 100 x 10^9 cells/L
- •Hemoglobin at least 9 g/dL
- •Aspartame aminotransferase (AST), alanine aminotransferase (ALT) less than 2.5X upper limit normal
- •Alkaline Phosphatase less than 1.5X upper limit normal
- •Creatinine less than 1.5 gm/dL
- •Normal left ventricular ejection fraction
- •Negative pregnancy test
- •Agree to use method to avoid pregnancy
- •Informed Consent is obtained
排除标准
- •Up to one regimen of prior neo-adjuvant or adjuvant chemotherapy is allowed. One year since Taxane and Herceptin treatment.
- •Cumulative life-time dose of doxorubicin is greater than 360 mg/m^2
- •Concurrent immunotherapy or hormonal therapy
- •Parenchymal brain metastases, if present, must be 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 congestive heart failure
- •History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer
- •Patients who have received an investigational drug within the previous 3 weeks
- •Patient is currently enrolled in another clinical study receiving investigational therapies
- •Pregnant or nursing women
研究组 & 干预措施
Albumin-bound paclitaxel, Carboplatin + Herceptin
Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
干预措施: Albumin-bound paclitaxel (Drug)
Albumin-bound paclitaxel, Carboplatin + Herceptin
Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
干预措施: Carboplatin (Drug)
Albumin-bound paclitaxel, Carboplatin + Herceptin
Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
干预措施: Herceptin® (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved an Objective Confirmed Complete or Partial Overall Response
时间窗: Objective response was evaluated every 2 cycles, up to a maximum of 39 cycles (approximately 39 months)
Percentage of participants who achieved 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 confirmed at least 4 weeks after initial documentation. A partial response (PR) is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing, or with the persistence of one or more non-target lesions and/or the maintenance of tumor marker level above the normal limits.
次要结局
- Duration of Response(Assessed every 2 cycles, up to a maximum of 39 cycles.)
- Time to Disease Progression(Assessed every 2 cycles, up to a maximum of 39 cycles.)
- Number of Participants With Adverse Events (AEs)(Day 1 up to 39 cycles)
- Percentage of Participants With a Total Response(Evaluated every 2 cycles, up to a maximum of 39 cycles.)
- Overall Patient Survival(From Day 1 until approximately 44 months.)