Open-Label, Phase II, Multicenter, Randomized Study of Efficacy and Safety for Two Different Doses of a Recombinant Humanized Antibody to HER2 (rhuMAb 2C4) Administered Every 3 Weeks to Patients With Metastatic Breast Cancer With Low Expression of HER2
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 79
- 主要终点
- Percentage of Participants Achieving a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR)
研究概览
简要总结
This study will evaluate the efficacy and safety of pertuzumab (rhuMAb 2C4) in participants with metastatic breast cancer which has progressed during or after standard chemotherapy and which is not amenable to curative therapy. Those who are maintaining a response to therapy or who have stable disease at the end of the formal study period will continue treatment until disease progression or unacceptable toxicity. Approximately 120 participants will be enrolled.
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
- •Females at least 18 years of age
- •Histologically-confirmed metastatic breast cancer with low HER2 expression and at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST)
- •Karnofsky performance status at least 80%
- •Disease progression on/after up to 2 different chemotherapy regimens, including an anthracycline-containing therapy
- •Left ventricular ejection fraction (LVEF) at least 50%
- •Adequate liver function
排除标准
- •Pleural effusions, ascites, or bone lesions as the only manifestation(s) of cancer
- •Pulmonary or central nervous system (CNS) metastases
- •Chemotherapy, radiotherapy, or immunotherapy within 4 weeks; or hormone therapy within 2 weeks of Day 1
- •Previous treatment with any drug that targets the HER2 receptor family
- •Previous treatment with corticosteroids as cancer therapy
- •History of significant cardiac disease
- •Major surgery or trauma within 4 weeks of Day 1
- •Pregnant or lactating women
研究组 & 干预措施
Pertuzumab 1050 mg
Participants will not receive a loading dose, but will receive pertuzumab 1050 milligrams (mg) via intravenous (IV) infusion every 3 weeks until unacceptable toxicity or disease progression.
干预措施: Pertuzumab (Drug)
Pertuzumab 420 mg
Participants will receive a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
干预措施: Pertuzumab (Drug)
结局指标
主要结局
Percentage of Participants Achieving a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR)
时间窗: Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)
Objective tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR was defined as the disappearance of all target lesions, and confirmed PR was defined as at least at 30 percent (%) decrease in the sum of the longest diameters of target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. The percentage of participants achieving a best overall response of CR or PR was calculated as \[number of participants meeting the above criteria divided by the number analyzed\] multiplied by 100.
次要结局
- Time to Response Among Participants Achieving a Best Overall Response of Confirmed CR or PR(Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response))
- Duration of Response Among Participants Achieving a Best Overall Response of Confirmed CR or PR(Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response))
- Percentage of Participants Achieving a Best Overall Response of Confirmed CR(Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response))
- Duration of Response Among Participants Achieving a Best Overall Response of Confirmed CR(Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response))
- Number of Participants Who Experienced PD or Death(Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response))
- Time to Progression(Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response))
- Number of Participants Who Experienced PD or Withdrew From the Study Early(Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response))
- Time to Treatment Failure(Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response))
- Percentage of Participants Who Died(Up to approximately 2 years (from start of treatment until death))
- Overall Survival(Up to approximately 2 years (from start of treatment until death))
- Percentage of Participants Achieving a Best Overall Response of SD(Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response))
- Apparent Half-Life (t1/2) of Pertuzumab(Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2)
- Maximum Plasma Concentration (Cmax) of Pertuzumab(Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2)
- Time to Maximum Plasma Concentration (Tmax) of Pertuzumab(Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2)
- Area Under the Concentration-Time Curve (AUC) of Pertuzumab(Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2)
- Systemic Clearance (CL) of Pertuzumab(Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2)
- Volume of Distribution at Steady State (Vss) of Pertuzumab(Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2)
- Mean Residence Time (MRT) of Pertuzumab(Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2)
- Number of Participants Experiencing a Drop in Left Ventricular Ejection Fraction (LVEF) to a Value of Less Than 50%(Up to approximately 1 year (at Baseline; at the end of Cycles 2, 4, 8, 12, and 16; and up to 7 weeks following the last infusion))