Pyrotinib in Combination With Nab-paclitaxel in Patients With HER2-positive Advanced Breast Cancer: an Exploratory Study

Study Overview
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Brief Summary
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This clinical trial aim to evaluate the efficacy and safety of Pyrotinib in combination with nab-paclitaxel in patients with HER2-positive advanced breast cancer.

Official Title
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Pyrotinib in Combination With Nab-paclitaxel in Patients With HER2-positive Advanced Breast Cancer: an Exploratory Study

Conditions
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HER2-positive Breast Cancer

Intervention / Treatment
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* Combination Product: pyrotinib maleate tablets+nab-paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Age: 18-70 years old，female; 2. Pathologically confirmed HER2-positive invasive breast cancer by local laboratory with the following requirements: HER2 overexpressed or amplified (immunohistochemistry of 3+ or HER2 gene amplification by in situ hybridization) 3. Imaging examination confirmed recurrent/metastatic breast cancer； 4. Patients must have previous treatment with trastuzumab more than 9 weeks; 5. Untreated for metastatic/metastatic disease (except for endocrinotherapy); 6. Patients with at least one measurable lesions by RECIST version 1.1； 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2； 8. Life expectancy greater than or equal to 3 months; 9. Participants must have normal organ and marrow function as described below： Absolute neutrophil count≥1.5×109/L; Platelets≥90×109/L; Hemoglobin ≥90g/L； Total bilirubin ≤ 1.5 X institutional upper limit of normal (ULN)； ALT and AST≤2*ULN, but ≤5*ULN with liver metastases; BUN and Cr≤1.5×ULN or creatinine clearance ≥50ml/min Left ventricular ejection fraction (LVEF) ≥ 50% 10. Doctors believe that treatment can bring benefits to patients； 11. Participants were willing to join in this study, and written informed consent. Exclusion Criteria: 1. A variety of factors influencing oral drugs (after resection of the gastrointestinal, unable to swallow, Chronic diarrhea, intestinal obstruction); 2. Patients with other malignant tumors within 5 years (except for skin basal cell carcinoma and cervical carcinoma in situ); 3. History of psychiatric drugs abuse or patients with mental disorders; 4. Pregnant or lactating women; 5. Less than 4 weeks from the last clinical trial 6. 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: pyrotinib maleate tablets+nab-paclitaxel<br>pyrotinib maleate tablets: 400mg orally once daily continunously; nab-paclitaxel: 125mg/m2 iv d1、8 of each 21 day cycle, 6cycles. | Combination Product: pyrotinib maleate tablets+nab-paclitaxel<br>* pyrotinib maleate tablets: 400mg orally once daily continunously nab-paclitaxel: 125mg/m2 iv d1、8 of each 21 day cycle, 6cycles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress-free survival(PFS) | Baseline to measured date of progress or death from any cause | three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | Baseline to measured stable disease | three years | 
| Clinical Benefit Rate (CBR) | The percentage of subjects with Complete Response, Partial Response, or Stable Disease at least 24 weeks | three years | 
| Disease control rate(DCR) | Rate of the patients with disease control | three years | 
| Overall survival (OS) | Baseline to measured date of death from any cause | up to death | 
| Safety (number of Participants with adverse events) | Adverse events Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. The number of Participants with adverse events will be recorded at each treatment visit. | three years |