A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF PF-05280014 PLUS PACLITAXEL VERSUS TRASTUZUMAB PLUS PACLITAXEL FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH HER2-POSITIVE METASTATIC BREAST CANCER
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 707
- 试验地点
- 180
- 主要终点
- Objective Response Rate (ORR) Derived From Central Radiology Assessments: ITT Population
研究概览
简要总结
The current study will compare the efficacy, safety, pharmacokinetics and immunogenicity of PF-05280014 in combination with paclitaxel versus trastuzumab sourced from the European Union (trastuzumab-EU) with paclitaxel in female patients with HER2-positive, metastatic breast cancer in the first-line treatment setting. The hypothesis to be tested in this study is that the efficacy (ORR) of PF-05280014 is similar to trastuzumab-EU.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Histologically confirmed diagnosis of breast cancer.
- •Presence of metastatic disease.
- •Documentation of HER2 gene amplification or overexpression.
- •Available tumor tissue for central review of HER2 status.
- •At least 1 measurable lesion as defined by RECIST 1.
- •Eastern Cooperative Oncology Group status of 0 to
- •Left ventricular ejection fraction within institutional range of normal, measured by either two dimensional echocardiogram or multigated acquisition scan.
排除标准
- •Relapse within 1 year of last dose of previous adjuvant (including neoadjuvant) treatment (except endocrine therapy) and within 1 year before randomization.
- •Prior systemic therapy for metastatic disease (except endocrine therapy).
- •Prior cumulative dose of doxorubicin of >400 mg/m2, epirubicin dose >800 mg/m^2, or the equivalent dose for other anthracyclines or derivatives (eg, 72 mg/m^2 of mitoxantrone). If the patient has received more than one anthracycline, then the cumulative dose must not exceed the equivalent of 400 mg/m^2 of doxorubicin.
- •Inflammatory breast cancer.
- •Active uncontrolled or symptomatic central nervous system metastases.
研究组 & 干预措施
PF-05280014
干预措施: PF-05280014 (Biological)
PF-05280014
干预措施: Paclitaxel (Drug)
Herceptin®
干预措施: Herceptin® (Biological)
Herceptin®
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Objective Response Rate (ORR) Derived From Central Radiology Assessments: ITT Population
时间窗: From the date of randomization until all participants had either completed the Week 33 tumor assessment or discontinued study drug earlier than the Week 33 visit
ORR was defined as the percentage of participants who achieved complete response (CR, complete disappearance of all target lesions with the exception of nodal disease; all target nodes must have decreased to normal size \[short axis \<10 mm\]) or partial response (PR, \>=30% decrease from baseline of the sum of diameters (SOD) of all target measurable lesions; the short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions) by Week 25 of the study and confirmed on a follow-up assessment (Week 33+/-14 days), based on the assessments of the central radiology review in accordance with RECIST 1.1.
次要结局
- Serum Peak Concentration of PF-05280014 at Selected Cycles: Pharmacokinetics (PK) Population(1 hour post end of infusion on Day 1 of Cycles 1 and 5)
- Serum Peak Concentration of Trastuzumab-EU at Selected Cycles: PK Population(1 hour post end of infusion on Day 1 of Cycles 1 and 5)
- One-year Progression-Free Survival (PFS) Rate Derived From Central Radiology Assessments: ITT Population(From the date of randomization until 378 days post-randomization)
- Duration of Response (DOR) Per Central Radiology Assessments: ITT Population(From the date of randomization until 378 days post-randomization)
- Overall Survival: ITT Population(From the date of randomization until end of study (approximately 6 years))
- Serum Trough (Pre-dose) Concentration of PF-05280014 at Selected Cycles: PK Population(Pre-dose on Day 1 of Cycles 1, 3, 4, 5, 7, 8, 11, 14, 17 and Day 8 of Cycles 1 and 5)
- Serum Trough (Pre-dose) Concentration of Trastuzumab-EU at Selected Cycles: PK Population(Pre-dose on Day 1 of Cycles 1, 3, 4, 5, 7, 8, 11, 14, 17 and Day 8 of Cycles 1 and 5)
- Number of Participants With Positive Neutralizing Antibodies (Nab) Prior to Treatment: Safety Population(Cycle 1 Day 1 (prior to treatment))
- Number of Participants With Positive Anti-Drug Antibodies (ADA) Sample: Safety Population(Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 11, 14, 17)