Anlotinib Combined With Chemotherapy for the Treatment of HER2 Negative Advanced Breast Cancer

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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HER2-negative Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anlotinib in combination with chemotherapy<br>anlotinib12mg qd p.o. d1-14/21day/cycle；eribulin 1.4 mg/m2，d1&d8/21day/cycle；capecitabine 1000 mg/m2，bid，d1-14/21day/cycle. | |
| chemotherapy<br>eribulin 1.4 mg/m2，d1&d8/21day/cycle；capecitabine 1000 mg/m2，bid，d1-14/21day/cycle. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) | PFS will be defined as the time from first dose of study drug until documentation of disease progression or death from any cause | up to 1 year after the last patient enrolled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate（ORR） | The ORR will be defined as the proportion of patients in the Efficacy Evaluable patient Set who achieve complete response (CR) and partial response (PR) | up to 1 year after the last patient enrolled | 
| Clinical benefit rate（CBR） | Proportion of patients with a complete response (CR), partial response (PR), and stable disease (SD) ≥24 weeks in the best objective tumor response | up to 1 year after the last patient enrolled | 
| overall survival（OS） | The time from the patient's initiation of treatment to death from any cause | up to 1 year after the last patient enrolled | 
| Incidence and Severity of adverse events | AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events). | up to 1 year after the last patient enrolled |