Anlotinib Combined With Chemotherapy for the Treatment of HER2 Negative Advanced Breast Cancer Previously Treated With Anthracyclines and Taxanes: A Multicenter, Prospective, Observational Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 315
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The study is being conducted to evaluate the efficacy and safety of anlotinib combined with chemotherapy treatment for patients with HER2 negative advanced breast cancer previously received anthracyclines and taxanes
详细描述
Breast cancer is the most frequent malignancy in women worldwide. Treatments on HER2 negative breast cancer are still under exploration. Therefore, it is imperative to find a novel therapy to treat these patients.
Anlotinib is an anti-angiogenic small-molecule butyrate kinase inhibitor, and preliminary phase II study results show that anlotinib has good efficacy and tolerability in the treatment of HER-2-negative advanced breast cancer.
This study is a prospective, multicenter, observational clinical study that will collect and report anlotinib in combination with anlotinib in patients with HER2-negative advanced breast cancer treated with anthracyclines and taxanes in a real-world clinical setting Efficacy and safety data for chemotherapy treatments.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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 old (calculated on the day of signing informed consent);
- •Histologically diagnosed advanced breast cancer, including inoperable locally advanced breast cancer or recurrent/metastatic breast cancer;
- •Immunohistochemical detection of HER-2 (-) or (1+), of which HER-2 (2+) must be tested by FISH and the result is negative;
- •All patients have previously underwent chemotherapy containing anthracyclines and taxanes (adjuvant, neoadjuvant or rescue therapy) , and treatment failure or disease progression received at most two chemotherapy regimens after recurrence/metastasis. HR+/HER2- breast cancer patients need to complete endocrine drug therapy;
- •Physical condition ECOG PS: 0-1;
- •There is at least 1 measurable lesion of metastasis according to RECIST 1.1;
- •The patients voluntarily joined the project and signed the informed consent.
排除标准
- •Pregnant or lactating women;
- •Patients with a previous history of breast cancer were excluded, except for ipsilateral DCIS who received only local therapy ≥5 years ago; patients with a history of any other cancer (except non-melanoma skin cancer or cervical carcinoma in situ) were excluded;
- •allergic to Anlotinib;
- •Received eribulin, capecitabine treatment or anti-angiogenic drug treatment in the past;
- •Uncontrolled brain metastases (except asymptomatic, or patients with stable brain metastases receiving local treatment);
- •According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: up to 1 year after the last patient enrolled
PFS will be defined as the time from first dose of study drug until documentation of disease progression or death from any cause
次要结局
- Clinical benefit rate（CBR）(up to 1 year after the last patient enrolled)
- overall survival（OS）(up to 1 year after the last patient enrolled)
- objective response rate（ORR）(up to 1 year after the last patient enrolled)
- Incidence and Severity of adverse events(up to 1 year after the last patient enrolled)