Efficacy and Safety of Neratinib as Extended Adjuvant Therapy in HER2-Positive Early Breast Cancer Patients Who Achieved pCR After Neoadjuvant Therapy But Have High-Risk Factors: A Multi-Center, Real-World Study From Hebei, China
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 170
- 主要终点
- Invasive Disease Free Survival (IDFS)
研究概览
简要总结
Neratinib is an oral, irreversible pan-HER tyrosine kinase inhibitor. Current treatment guidelines recommend neratinib as an extended adjuvant therapy for HER2-positive breast cancer patients to further reduce the risk of recurrence.
Even when HER2-positive breast cancer patients achieve pathological complete response (pCR) after neoadjuvant therapy, those with high-risk factors (such as large tumors [cT3/T4] or lymph node-positive disease) still face a risk of cancer returning. However, there is limited data on the effectiveness and safety of neratinib in these patients.
This study aims to provide real-world evidence on how well neratinib works in high-risk HER2-positive breast cancer patients who achieved pCR, helping to improve treatment strategies for Chinese patients.
详细描述
This study is a single-arm prospective study with historical controls as external comparators
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Age ≥18 years, female
- •Clinical stage ≥cT3 or ≥cN1, regardless of hormone receptor (HR) status
- •HER2-positive: HER2 IHC 3+ or IHC 2+ with ISH+
- •Achieved pathological complete response (pCR) after neoadjuvant therapy
- •Completed 1 year of standard adjuvant therapy (including trastuzumab), with ≤6 months between the last adjuvant treatment and starting neratinib
- •No evidence of recurrence or metastatic disease (confirmed by clinical/imaging exams after completing standard adjuvant therapy and before starting neratinib)
- •Left ventricular ejection fraction (LVEF) ≥50%
- •ECOG performance status 0-1
排除标准
- •Hypersensitivity to any component of the investigational drug
- •Inability to swallow oral medication
- •Participation in another interventional clinical trial within 4 weeks before enrollment, or planned participation during this study
- •Use of any investigational drug within 14 days prior to treatment initiation
- •Concurrent chemotherapy, radiotherapy, immunotherapy, or biologic therapy for breast cancer
- •Severe psychiatric disorders preventing compliance with informed consent, treatment, or follow-up procedures
- •Pregnancy, lactation, or plans for pregnancy in the near future
- •Other significant medical conditions or laboratory abnormalities that, in the investigator's judgment, make participation unsuitable
结局指标
主要结局
Invasive Disease Free Survival (IDFS)
时间窗: From Day 1 of treatment until 2 years after treatment completion
IDFS, as defined by the STEEP System, was measured from the date of treatment to the date of first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer, death attributable to any cause.
次要结局
- Disease Free Survival (DFS)(From Day 1 of treatment until 2 years after treatment completion)
- Overall Survival (OS)(From Day 1 of treatment until 2 years after treatment completion)
- Distant Disease-free Survival (DDFS)(From Day 1 of treatment until 2 years after treatment completion)
- Time to distant recurrence(From Day 1 of treatment until the first distant tumor recurrence or metastasis)
- Cumulative incidence of CNS recurrence(From Day 1 of treatment until 2 years after treatment completion)
- Incidence of grade ≥3 diarrhea(From consent to 28 days after last dose)
- Incidence and severity of other adverse events (AEs)(From consent to 28 days after last dose)
- Treatment patterns of patients(From Day 1 of treatment until last dose)