Prospective, Multicenter, Observational Study of Apatinib Single or Combined Capecitabine for Treatment of Patients With Metastatic Her-2 Negative Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy and safety of patients who receive apatinib single or combined capecitabine for treatment of patients with metastatic her-2 negative breast cancer.

Official Title
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Prospective, Multicenter, Observational Study of Apatinib Single or Combined Capecitabine for Treatment of Patients With Metastatic Her-2 Negative Breast Cancer

Conditions
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Breast Cancer Metastatic

Intervention / Treatment
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* Drug: Apatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 70 years old (female) Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Pathologically diagnosed with her-2 negative, ER/PR negative, ER/PR positive after the failure of endocrine treatment, and had not more than three chemotherapy regimens (must include anthracycline-based and yew class), and the final failure of chemotherapy regimens in patients with advanced breast cancer; Note: treatment failure include (1) during or after the completion of six months or less disease progress of neoadjuvant or adjuvant therapy; (2) rescue treatment in progress within 3 months or less Patients with at least one measurable lesions of the advanced breast cancer， measurable lesions has not received radiotherapy or other treatment, unless progress after treatment (measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1 and WHO); Major organ function has to meet the following certeria: For results of blood routine test (without blood transfusion within 14 days) HB≥100g/L; ANC≥1.5×109/L; PLT≥75×109/L; For results of blood biochemical test： TBIL<1.5ULN； ALTand AST<2.5ULN, but5<ULN if the transferanse elevation is due to liver metastases； Serum creatinine ≤1.25ULN , or calculated creatinine clearance>45 ml/min(per the Cockcroft-Gault formula); 6.Participants were willing to join in this study, and written informed consent. Exclusion Criteria: The patients with the failure of capecitabine treatment； The patients with chest wall invasion, or chest wall large canker has a tendency to transfer； Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), with classⅡand above coronary heart disease, unable to control arrhythmia (including QTc lengthened women > 470 ms) and classⅢ-Ⅳcardiac insufficiency; or Left ventricular ejection fraction (LVEF) < 50%； A variety of factors influencing oral drugs (such as unable to swallow, after resection of the gastrointestinal, chronic diarrhea and intestinal obstruction, etc.)； Has a history of bleeding, the clinical significance of bleeding symptoms, patients with definite bleeding tendency, such as gastrointestinal bleeding, bleeding ulcers, baseline period （+ +）and above of defecate occult blood, vasculitis, etc； Received a major surgery within 4 weeks or severe traumatic injury, fractures, or has a poor healing wound； Allergic to apatinib and supplementary material； Patients with active brain metastases; Patients with pregnant or planning a pregnancy; The researchers think inappropriate.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: apatinib<br>apatinib 500mg qd po or combined Capecitabine 1000mg/m2 bid d1-d14 q3w | Drug: Apatinib<br>* apatinib 500mg qd po or combined capecitabine 1000mg/m2 bid d1-14 q3w<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | Baseline to measured date of progression or death from any cause | evaluated in 24 months since the treatment began | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Baseline to measured date of death from any cause | the first day of treatment to death or last survival confirm date,up to 24 months | 
| Disease control rate | Baseline to measured progressive disease | tumor assessment every 6 weeks since the treatment began，up to 24 months | 
| Objective response rate | Baseline to measured stable disease | tumor assessment every 6 weeks since the treatment began，up to 24 months | 
| Side effects | throughout study | evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 |