The Efficiency for Patient With Stage II-III HR+/HER2+ Early Breast Cancer With Standard Neoadjuvant Therapy: a Retrospective, Multicenter Study in Real World Settings.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Total pathological complete response (tpCR)
研究概览
简要总结
To observe the efficiency for patient with stage II-III HR+/HER2+ early breast cancer with standard neoadjuvant therapy, a retrospective, multicenter study in real world settings.
详细描述
This study collected patients used standard neoadjuvant therapy (TCbHP/THP/EC-THP/AC-THP) among stage II-III HR+/HER2+ early breast cancer, and to describe patient clinical characteristics and clinical outcomes of them in real world settings.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Age ≥18 years or older
- •HR+/HER2- breast cancer diagnosis based on local standards
- •Women having stage II-III breast cancer diagnosed based on AJCC cancer staging system (8th edition) who will be admitted because of breast cancer for the first time
- •Standard Therapy, determined at the discretion of the investigator, including （TCbHP/THP/EC-THP/AC-THP）
- •Complete medical history was available
- •Karnofsky Performance Status (KPS) Scale score ≥ 70
排除标准
- •Women who have received any form of anti-tumor treatment - (chemotherapy, radiotherapy, molecular targeted therapy, or endocrine therapy)
- •Pregnant or breast-feeding women
- •Those who have bilateral breast cancer, inflammatory breast cancer or occult breast cancer
- •Those who have stage IV breast cancer
研究组 & 干预措施
Stage II-III HR+/HER2+ Early Breast Cancer
Stage II-III HR+/HER2+ Early Breast Cancer
干预措施: Standard Therapy (Drug)
结局指标
主要结局
Total pathological complete response (tpCR)
时间窗: through study completion, an average of 1 year
tpCR is defined as the absence of residual invasive cancer on resected breast specimen and the sampled regional lymph nodes as shown by hematoxylin-eosin staining after completion of the neoadjuvant treatment.
次要结局
- Best overall response rate (BORR) [ Time Frame: During neoadjuvant treatment(through study completion, an average of 1 year)
- Residual cancer burden (RCB)(through study completion, an average of 1 year)