NCT05891561招募中2 期
Short-course Trastuzumab, Pertuzumab Combined with Taxanes in the Adjuvant Treatment of Early Human Epidermal Growth Factor Receptor 2-positive Breast Cancer: an Open-label, Single-arm Study
Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年11月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Disease free survival [DFS]
研究概览
简要总结
The investigators plan to carry out a phase II, open-label, single-arm clinical study of short-course trastuzumab, pertuzumab combined with taxanes in the adjuvant treatment of early HER2-positive breast cancer, to explore whether 4 courses of dual HER2 blockade combined with taxanes can lead to a similar prognosis with current standard treatment, which is one-year trastuzumab monotherapy combined with chemotherapy, while reducing the adverse reactions of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically diagnosed unilateral primary invasive breast cancer patient with pT1, pN0, and M0 disease
- •HER2-positive, ie. immunohistochemistry [IHC] 3+ or IHC 2+ and fluorescence in situ hybridisation [FISH]-positive according to ASCO/CAP 2018 guidelines
- •complete clinical pathological information
- •Eastern Cooperative oncology Group [ECOG] 0-1
- •Currently not pregnant or breast-feeding
- •Fine organ function
- •Have good compliance with planned treatment, understand the study process and sign a written informed consent
排除标准
- •Bilateral or metastatic breast cancer
- •Receiving neoadjuvant treatment
- •Other malignancies within 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer
- •Severe systemic infections or other serious illnesses
- •HIV infection, active hepatitis B or C infection
- •Known allergy to or intolerance to a therapeutic drug or its excipients
- •Prior history of chemotherapy, endocrine therapy, biotherapy, or radiation therapy for any reason
- •Enrollment of another investigational study within 4 weeks prior to initial administration of the investigational treatment
- •Receiving live vaccine within 30 days prior to initial administration of the investigational treatment
- •History of mental illness or drug abuse that may affect compliance with the trial requirements
- •The researchers determine that the patients were not suitable for the study
研究组 & 干预措施
Pertuzumab
Experimental
4 cycles of taxane, Pertuzumab, Trastuzumab
干预措施: Pertuzumab (Drug)
结局指标
主要结局
Disease free survival [DFS]
时间窗: 3 year
Time from surgery to first proven loco-regional recurrence, distant recurrence, second non-breast malignancy, or death from any cause
次要结局
- Overall survival [OS](3 year)
- Distant disease-free survival [DDFS](3 year)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(3 year)
研究者
Kunwei Shen
Professor
Shanghai Jiao Tong University School of Medicine
研究点 (1)
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