A New Option for Post-CDK4/6is Resistance Era: Multicenter Real-world Study of Anlotinib-based Combination Therapy in Hormone Receptor-positive Metastatic Breast Cancer Resistant to CDK4/6is.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
Cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors combined with hormonal therapy are the current standard frontline treatment for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER-2)-negative metastatic breast cancer (MBC). However, the optimal treatment after progression on CDK4/6 inhibitors remains unknown. Anlotinib is an oral multi-target tyrosine kinase inhibitor (TKI) that strongly inhibits VEGFR, PDGFR, FGFR, and c-kit. This study aimed to evaluate the safety and efficacy of anlotinib-based combination therapy in patients with HR+ MBC previously treated with a CDK4/6 inhibitor.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •Female patients aged 18 to 75 years, with an ECOG score of 0-1, and an expected survival of at least 3 months;
- •Presence of measurable lesions as defined by RECIST 1.1 criteria;
- •Histopathologically confirmed HR-positive/HER2-negative breast cancer. HER2 negativity is determined by an immunohistochemistry (IHC) result of HER2 (0/1+). If the result is HER2 (++), a FISH or CISH test is required to confirm the absence of HER2 amplification;
- •Patients who have undergone multiple lines of advanced therapy with no remaining standard treatment options;
- •Prior treatment with at least one line of CDK4/6 inhibitors and endocrine therapy;
- •Disease progression following aromatase inhibitor (AI) or fulvestrant combined with CDK4/6 inhibitors, either as adjuvant therapy or as systemic treatment for advanced disease.
排除标准
- •Patients with HER2-positive breast cancer confirmed by histology or cytology;
- •Patients who discontinued therapy due to non-disease progression reasons, such as adverse events or other non-medical factors;
- •Detection of a second primary malignant tumor at the time of enrollment;
- •Failure to complete CDK4/6 inhibitor therapy;
- •Pregnant or breastfeeding patients;
- •Presence of third-space fluid accumulation (e.g., pleural effusion, ascites, pericardial effusion) that cannot be managed through drainage or other methods;
- •Patients previously treated with anti-angiogenic agents, including small molecules such as anlotinib or apatinib, and large molecules such as bevacizumab;
- •Patients currently receiving any other anti-tumor treatment for any other malignancies.
结局指标
主要结局
Progression free survival (PFS)
时间窗: through study completion, an average of 1 year
Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.
次要结局
- Disease control rate (DCR)(through study completion, an average of 1 year)
- Objective response rate (ORR)(through study completion, an average of 1 year)
- Overall survival(OS)(through study completion, an average of 5 year)
- Incidence of Treatment-Emergent Adverse Events (Safety)(through study completion, an average of 1 year)