Real-world Bicohort Observational Study of a Pertuzumab Biosimilar in the Treatment of Breast Cancer: in the Neoadjuvant Setting and in First-line Metastatic Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Treatment Regimen Utilization
研究概览
简要总结
The goal of this observational study is to describe the real-world utilization patterns of a pertuzumab biosimilar and to evaluate its clinical outcomes in patients with breast cancer in both neoadjuvant and metastatic settings. It also aims to assess pathological complete response (pCR), disease-free survival (DFS) in the neoadjuvant cohort, progression-free survival (PFS) in the metastatic cohort, overall survival (OS), treatment response, and safety and tolerability (adverse events according to CTCAE) across both cohorts.
详细描述
This is a non-interventional, prospective, multicenter, bicohort observational study conducted in a real-world setting. It aims to describe the clinical and therapeutic characteristics of patients treated with a pertuzumab biosimilar and to evaluate outcomes in both neoadjuvant and metastatic settings. Approximately 1,000 patients will be included, with 500 patients per cohort. Cohort 1 includes patients receiving a pertuzumab biosimilar in the neoadjuvant treatment of HER2-positive breast cancer, while Cohort 2 includes patients treated in the first-line metastatic setting for HER2-positive metastatic breast cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 19 years at the time of inclusion;
- •Histologically confirmed diagnosis of HER2-positive invasive breast cancer (IHC 3+ score or HER2 amplification by FISH/CISH/SISH);
- •Decision to initiate treatment with a pertuzumab biosimilar in the neoadjuvant setting (neoadjuvant cohort) or as first-line therapy in the metastatic setting (metastatic cohort), in accordance with local indications;
- •Treatment prescribed as part of routine clinical care (outside of a clinical trial);
- •Patient informed and having provided written informed consent.
排除标准
- •Treatment with pertuzumab in a therapeutic setting other than neoadjuvant or first-line metastatic (e.g., adjuvant, late recurrence beyond first-line, maintenance therapy alone, etc.);
- •Treatment administered as part of an interventional clinical trial;
- •History of severe allergy or known contraindication to pertuzumab;
- •Medical records unavailable or inability to ensure at least 6 months of minimal follow-up.
研究组 & 干预措施
Cohort 1
Patients treated with a pertuzumab biosimilar in the neoadjuvant setting for HER2-positive breast cancer.
Cohort 2
Patients treated with a pertuzumab biosimilar as first-line therapy in the metastatic setting for HER2-positive metastatic breast cancer.
结局指标
主要结局
Treatment Regimen Utilization
时间窗: Up to 36 months
Percentage (%) of patients receiving each pertuzumab biosimilar-containing treatment regimen.
Line of Therapy
时间窗: Up to 36 months
Percentage (%) of patients receiving pertuzumab biosimilar as neoadjuvant therapy or first-line treatment in metastatic setting.
Treatment Duration
时间窗: Up to 36 months
Median duration of treatment (in months) with pertuzumab biosimilar.
Prescribing Context
时间窗: Up to 36 months
Percentage (%) of prescriptions initiated in neoadjuvant versus metastatic setting.
Methods of Response Assessment
时间窗: Up to 36 months
Percentage (%) of patients assessed using clinical, radiological, and/or pathological methods.
次要结局
- Overall Survival (OS) (Both Cohorts)(Up to 24 months)
- Pathological Complete Response (pCR) Rate (Neoadjuvant Cohort)(Up to 12 months)
- Disease-Free Survival (DFS) (Neoadjuvant Cohort)(Up to 24 months)
- Progression-Free Survival Rate at 24 Months (PFSR) (Metastatic Cohort)(24 months)
- Progression-Free Survival (PFS) (Metastatic Cohort)(Up to 24 months)
- Treatment Response (Both Cohorts)(Up to 24 months)
- Incidence and Severity of Adverse Events(Up to 24 months)