A Multicenter, Prospective, Real World, National Study to Assess the Efficacy and Safety of Adjuvant Biosimilar Tratuzumab (Zedora) Treatment in Patients With Localized Her2 Positive Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 170
- 试验地点
- 22
- 主要终点
- Safety endpoints: Incidence of Related Adverse Events
研究概览
简要总结
Zedora registration was based on studies of women with metastatic breast cancer, but its approval includes adjuvant treatment. Thus, prospective data of drug use in localized disease are lacking, as well as are real-world safety and efficacy data, taking into consideration comorbidities and compliance difficulties.
This will be an observational study of patients receiving adjuvant Zedora at several Brazilian institutions for the purpose of describing its efficacy and safety.
详细描述
An observational, multicenter, prospective, real-world study at Brazilian institutions.
Adult patients with early HER2+ breast cancer receiving adjuvant biosimilar trastuzumab (Zedora) at the participating sites after the start of the study and meeting the eligibility criteria will be invited to participate. Demographics, comorbidities, disease history, extent of exposure to biosimilar trastuzumab (Zedora), adverse events and LVEF values will be collected.
Data collection will be performed using a case report form (CRF) specifically designed for the study.
Study Treatment:
Biosimilar trastuzumab (Zedora) must be prescribed at the dosage described in the product label.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •female patients aged 18 years and over
- •diagnosis of early stage I to III breast cancer confirmed by histopathology test according to local guidelines.
- •human epidermal growth factor receptor 2 (HER2)-positive tumor by immunohistochemistry or FISH (Fluorescence In Situ Hybridization), as per the 2018 ASCO assessment guideline [J Clin Oncol 36:2105, 2018].
- •use of at least one dose of biosimilar trastuzumab (Zedora) as adjuvant therapy, regardless of previous neoadjuvant trastuzumab or Zedora use or the type of chemotherapy combined with the antibody.
- •Signing of the informed consent form (ICF).
排除标准
- •use of biosimilar trastuzumab (Zedora) differently from the provisions in the label.
- •patients enrolled in and followed up by Programa Vida Plena [Full Life Program].
结局指标
主要结局
Safety endpoints: Incidence of Related Adverse Events
时间窗: 5 years
Incidence of Related Adverse Events
Safety endpoints: Incidence of dose interruption
时间窗: 5 years
Incidence of dose interruption
Efficacy endpoints: Invasive disease relapse-free survival rate
时间窗: 36 months
Invasive disease relapse-free survival rate
Efficacy endpoints: Invasive disease relapse-free survival after curative-intent surgery
时间窗: 5 years
Invasive disease relapse-free survival after curative-intent surgery
Efficacy endpoints: Overall survival after curative intent surgery
时间窗: 5 years
Overall survival after curative intent surgery
Safety endpoints: Total cycles per patient
时间窗: 5 years
Total cycles per patient
次要结局
未报告次要终点