Retrospective Real-World Cohort Study on the Impact of Different Adjuvant Treatment Regimens on Prognosis in Non-pCR Patients With HER2-Positive Breast Cancer After Neoadjuvant Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,000
- 主要终点
- Three-year invasive disease-free survival (iDFS) rate for non-pCR patients
研究概览
简要总结
This study is a multicenter, retrospective, real-world cohort study. It retrospectively collected data from HER2-positive breast cancer patients who received neoadjuvant therapy with trastuzumab-containing chemotherapy regimens and had Non-pCR after surgery between July 2019 and July 2025. Patients were divided into two groups based on their adjuvant treatment regimens: the trastuzumab combined with pertuzumab group (HP) and the ado-trastuzumab emtansine group (T-DM1). The planned sample size is 2000 cases.
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
- •Histopathologically confirmed HER2-positive breast cancer (i.e., immunohistochemistry (IHC) staining result of 3+, or HER-2 2+ with fluorescence in situ hybridization showing HER-2 gene amplification);
- •Received neoadjuvant therapy with chemotherapy combined with trastuzumab before surgery: including at least 6 cycles of chemotherapy, with at least 4 cycles of taxane-based chemotherapy; and at least 4 cycles of trastuzumab treatment (including trastuzumab biosimilars and subcutaneous formulations);
- •Completion of radical surgery, postoperative pathology confirms the presence of invasive carcinoma in the breast and/or axillary lymph nodes after neoadjuvant therapy.
- •Hormone receptor status is known.
排除标准
- •Combine other systemic malignant tumors, excluding cured basal cell carcinoma of the skin and cervical carcinoma in situ;
- •Stage IV metastatic breast cancer;
- •Incomplete clinical pathology and follow-up data; Study endpoints
研究组 & 干预措施
HP
The trastuzumab combined with pertuzumab group
T-DM1
The ado-trastuzumab emtansine group
结局指标
主要结局
Three-year invasive disease-free survival (iDFS) rate for non-pCR patients
时间窗: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
iDFS events include local and regional recurrence, distant metastasis, contralateral invasive breast cancer, second non-breast primary cancer (excluding non-invasive carcinoma in situ), and death from any cause at 3 years.
次要结局
- 3-year iDFS rate in Near-pCR patients:(From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.)
- Overall survival(It is a direct measure of the treatment's ultimate impact on patient survival.)
- Adverse Events(From date of enrollment until adjuvant therapy after surgery 1 year)
研究者
Tao Zhou
Attending Physician
Hebei Medical University Fourth Hospital