A Multicenter Retrospective Cohort Study Protocol on the Prognostic Impact of HER2 Expression in Non-Metastatic HER2-Positive Breast Cancer Treated With Dual HER2-Targeted Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Disease-free survival based on HER2/CEP17 ratio
研究概览
简要总结
Previous studies suggest that among patients receiving trastuzumab monotherapy, a HER2/CEP17 ratio >7.0 (ultra-high expression) is associated with poorer disease-free survival (DFS). Dual-target therapy (trastuzumab + pertuzumab) has become the standard treatment for high-risk HER2-positive breast cancer; however, whether it can predict outcomes in patients with ultra-high HER2 expression remains unsupported by clinical data. To analyze the clinicopathological characteristics and prognostic relationship between the HER2 ultra-high expression group and the normal expression group in non-metastatic HER2-positive breast cancer patients who received dual-target therapy.
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.
- •Pathologically confirmed primary breast cancer, clinical stage I-III (AJCC 8th Edition).
- •HER2-positive status confirmed by FISH testing (per ASCO/CAP guidelines) with available HER2/CEP17 ratio.
- •Received at least one dose of dual-target therapy (trastuzumab combined with pertuzumab) in the adjuvant or neoadjuvant setting.
- •Underwent curative-intent surgery (mastectomy or breast-conserving surgery).
排除标准
- •Presence of distant metastasis (Stage IV) or contralateral breast cancer at initial diagnosis.
- •Previous anti-HER2 targeted therapy prior to dual-target treatment.
- •Missing key clinical data (e.g., HER2 FISH results, treatment regimen, surgery date).
- •Carcinoma in situ or occult breast cancer, non-primary breast cancer, or concurrent other malignancies.
- •Loss to follow-up or follow-up duration <3 months (unless recurrence or death occurred within this period).
研究组 & 干预措施
HER2 FISH ultra
HER2/CEP17 FISH ratio in HER2-positive non-metastatic breast cancer
HER2 FISH normal
HER2/CEP17 FISH ratio in HER2-positive non-metastatic breast cancer
结局指标
主要结局
Disease-free survival based on HER2/CEP17 ratio
时间窗: From the date of pathological diagnosis to event with follow-up duration ≥3 months (unless recurrence or death occurred within 3 month).
Defined as the period from the date of pathological diagnosis until the date of the first relapse, appearance of non-breast primary cancer, death with no signs or symptoms of recurrence or metast, or the last recorded follow-up ,whichever came first.
次要结局
未报告次要终点
研究者
Fangchao Zheng, MD
Clinical associate professor
Shandong Cancer Hospital and Institute