A RANDOMIZED, DOUBLE-BLIND PHARMACOKINETIC STUDY OF PF-05280014 PLUS TAXOTERE (REGISTERED) AND CARBOPLATIN VERSUS HERCEPTIN (REGISTERED) PLUS TAXOTERE (REGISTERED) AND CARBOPLATIN FOR THE NEOADJUVANT TREATMENT OF PATIENTS WITH OPERABLE HER2-POSITIVE BREAST CANCER
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 226
- 试验地点
- 51
- 主要终点
- Percentage of Participants With Steady State Drug Concentration Ctrough (Cycle 6 Pre-dose) >20 µg/mL at Cycle 5.
研究概览
简要总结
The current study will compare PK, efficacy, safety, and immunogenicity of PF-05280014 (Trastuzumab-Pfizer) in combination with Taxotere® and Carboplatin (Paraplatin) versus Herceptin® (Trastuzumab-EU) approved in the EU in combination with Taxotere® and Carboplatin (Paraplatin) in patients with operable HER2 positive, breast cancer in the neoadjuvant setting. The hypothesis to be tested in this study is the percentage of patients with steady state Cycle 5 Ctrough (Cycle 6 pre-dose) >20 µg/mL of trastuzumab-Pfizer is similar to EU-approved trastuzumab, using a margin of -12.5%.
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 HER2 overexpressing invasive breast cancer.
- •Plan for definitive surgical resection of breast tumor (i.e., lumpectomy or mastectomy, and sentinel node (SN) biopsy or axillary lymph node dissection (ALND).
- •Plan for neoadjuvant chemotherapy.
- •Measurable disease in the breast after diagnostic biopsy, defined as longest diameter ≥ 2.0 cm.
排除标准
- •Bilateral breast cancer.
- •Inflammatory breast cancer.
- •Presence of known distant metastases.
- •Received prior treatment, including chemotherapy, endocrine therapy, biologic therapy, radiation or surgery with the exception of diagnostic biopsy for primary breast cancer.
研究组 & 干预措施
PF-05280014
干预措施: PF-05280014 (Biological)
PF-05280014
干预措施: Taxotere® (Drug)
PF-05280014
干预措施: Paraplatin® (Drug)
Herceptin®
干预措施: Trastuzumab-EU (Biological)
Herceptin®
干预措施: Taxotere® (Drug)
Herceptin®
干预措施: Paraplatin® (Drug)
结局指标
主要结局
Percentage of Participants With Steady State Drug Concentration Ctrough (Cycle 6 Pre-dose) >20 µg/mL at Cycle 5.
时间窗: Cycle 5
The percentage of participants with Cycle 5 Ctrough (Cycle 6 pre-dose) \>20 μg/mL in each treatment group, the denominator being the number of participants in the per protocol population for each treatment group.
次要结局
- Mean Predose Trastuzumab-Pfizer and Trastuzumab-EU Concentrations at Cycles 1 Through 6.(Cycles 1 through 6)
- Pathologic Complete Response (pCR) Defined as the Absence of Invasive Neoplastic Cells in the Breast and Lymph Nodes.(Cycle 6/End of treatment)
- Objective Response Rate (ORR) Defined as the Percentage of Participants Having Complete or Partial Response at End of Treatment, Based on Radiographic Assessments of the Tumor.(Cycle 6/End of treatment)
- Incidence of Anti-trastuzumab Antibodies (ADAs) at Cycles 1 Through 6.(Cycles 1 through 6)
- Incidence of Neutralizing Antibodies (NAb) at Cycles 1 Through 6.(Cycles 1 through 6)