Oral Metronomic Capecitabine Combined With Pyrotinib in ADC-treated HER2-positive Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This is a prospective, open-label, multi-cohort, phase II study to evaluate the efficacy and safety of Oral metronomic capecitabine combined with pyrotinib in patients with HER2-positive advanced breast cancer who had received prior anti-HER2 ADC drugs (including T-DXd, SHR-A1811, T-DM1, etc.) before treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 and ≤75 years.
- •Histologically or cytologically confirmed HER2-positive metastatic breast cancer.
- •Patients must have either experienced disease progression following anti-HER2 antibody-drug conjugate (ADC) therapy in the advanced/metastatic setting (including regimens containing SHR-A1811, T-DXd, T-DM1, or other approved ADCs) or discontinued prior anti-HER2 ADC treatment due to intolerable toxicity, financial constraints, or patient preference without evidence of disease progression.
- •ECOG performance status of 0 to
- •The functions of the main organs are basically normal
- •Signed informed consent
排除标准
- •Prior treatment with a TKI or capecitabine (or other fluoropyrimidine-based chemotherapy) in the advanced or metastatic setting.
- •Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- •Pregnant or lactating patients;
- •Malignancy (except basal cell carcinoma of the skin, which has been cured, and carcinoma in situ of the cervix) in the past 5 years;
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent or accompanying supportive medications;
- •Serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study or interfere with the study results
- •Deemed by the investigator to be ineligible for participation in the study.
研究组 & 干预措施
pyrotinib plus capecitabine
Patients who experienced disease progression (PD) following front-line treatment with an ADC-based regimen received pyrotinib in combination with metronomic capecitabine until disease progression or unacceptable toxicity.
干预措施: Pyrotinib (Drug)
pyrotinib plus capecitabine
Patients who experienced disease progression (PD) following front-line treatment with an ADC-based regimen received pyrotinib in combination with metronomic capecitabine until disease progression or unacceptable toxicity.
干预措施: Capecitabine (Drug)
pyrotinib and capecitabine
Patients without disease progression who discontinued front-line ADC therapy due to intolerable toxicity, economic reasons, or patient preference were enrolled and received pyrotinib plus metronomic capecitabine until disease progression or unacceptable toxicity.
干预措施: Pyrotinib (Drug)
pyrotinib and capecitabine
Patients without disease progression who discontinued front-line ADC therapy due to intolerable toxicity, economic reasons, or patient preference were enrolled and received pyrotinib plus metronomic capecitabine until disease progression or unacceptable toxicity.
干预措施: Capecitabine (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: The observation period related to this endpoint is up to 36 months.
次要结局
- Overall Survival (OS)(The observation period related to this endpoint is up to 36 months.)
- Objective response rate (ORR)(The observation period related to this endpoint is up to 36 months.)
- Clinical Benefit Rate (CBR)(The observation period related to this endpoint is up to 36 months.)
- Safety(adverse Events [AEs] and Serious Adverse Events [SAEs])(From consent through 28 days following treatment completion)
研究者
Ma Fei，MD
Department of Medical Oncology
Cancer Institute and Hospital, Chinese Academy of Medical Sciences