De-escalation Neoadjuvant Therapy for Intermediate Risk HER2-positive Early Breast:a Randomised,Open-label,Multicentre,Phase 3 Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 592
- 主要终点
- pCR
研究概览
简要总结
High pathological complete response (pCR) rates are seen using different neoadjuvant chemotherapy schedules with trastuzumab and pertuzumab in HER2-positive stage II-III breast cancer patients. Total pCR rates in breast and axilla have been described as high as 64%, and with an even higher rate of >80% in patients with HER2-positive and hormone receptor (HR) negative tumors.
pCR is associated with better long-term outcomes in patients with HER2-positive breast cancer. Neoadjuvant treatment of HER2-positive breast cancer typically consists of six cycles of treatment. Longer duration of treatment is associated with higher pCR-rates but also with increased toxicity. It is therefore important to investigate which patients can safely be treated with less than six cycles of chemotherapy and which patients require six cycles for maximum efficacy.It is hypothesized that patients with a complete pathologic response may not benefit from additional chemotherapy, while those with residual invasive disease require further treatment. This study will evaluate de-escalation of the number of neoadjuvant chemotherapy cycles in intermediate risk HER2-positive breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathologically confirmed HER2-positive invasive breast cancer; Clinical staging of disease classified as T2N0M0.
排除标准
- •Patients who have undergone chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for this condition; Due to severe and uncontrolled medical conditions, the investigator deems chemotherapy contraindicated.
研究组 & 干预措施
THP×4
THP×4 Q3W (n=296) (Investigator-selected taxane* + Trastuzumab IV 6 mg/kg, loading dose 8 mg/kg + Pertuzumab IV 420 mg, loading dose 840mg)
干预措施: THP×4 Q3W (n=296) (Investigator-selected taxane* + Trastuzumab IV 6 mg/kg, loading dose 8 mg/kg + Pertuzumab IV 420 mg, loading dose 840mg) (Drug)
THP×6
THP×6 Q3W (n=296) (Investigator-selected taxane* + Trastuzumab IV 6 mg/kg, loading dose 8 mg/kg + Pertuzumab IV 420 mg, loading dose 840mg)
干预措施: THP×6 Q3W (n=296) (Investigator-selected taxane* + Trastuzumab IV 6 mg/kg, loading dose 8 mg/kg + Pertuzumab IV 420 mg, loading dose 840mg) (Drug)
结局指标
主要结局
pCR
时间窗: 18 weeks.
The primary endpoint was locally determined pathological complete response(pCR, ypT0/is, ypN0).
次要结局
未报告次要终点
研究者
Kun Wang
MD, PhD
Guangdong Provincial People's Hospital