A Study of Pyrotinib Plus Vinorelbine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer

Study Overview
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Brief Summary
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Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER1, HER2 and HER4 receptors. This study is a single-arm, prospective, open label clinical study of pyrotinib plus vinorelbine as the therapy of brain metastases from HER2-positive metastatic breast cancer.

Official Title
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Pyrotinib Plus Vinorelbine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer : a Prospective, Single-arm, Open-label Study

Conditions
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Breast Cancer, Brain Metastases

Intervention / Treatment
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* Drug: Pyrotinib Plus Vinorelbine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age18-75 years. ECOG performance status ≤2. Histologically confirmed HER2 positive advanced breast cancer. Prior to anthracyclines and taxanes (neoadjuvant, adjuvant and metastatic setting). Received ≤4 regimes in metastatic setting. Prior to trastuzumab is allowed. Not received whole brain radiotherapy (WBRT) or recurrence after WBRT. Controlled CNS symptoms (headache, dizziness, lethargy, nausea etc.). Patients with CNS metastasis; at least one CNS metastases with a longest diameter ≥1 cm and a diameter perpendicular to the longest diameter should be ≥0.5 cm; Signed the informed consent form prior to patient entry. Exclusion Criteria: Participated in other drug clinical trials within 4 weeks before the start of the study; Received radiotherapy, chemotherapy, surgery and target therapy within 4 weeks before the start of the study; Received endocrine therapy within 7 days before the start of the study; Suitable for surgical resection; Accompanied by rapid progress of organ invasion; Factors influencing the usage of oral administration (such as unable to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction etc.). Prior to pyrotinib or vinorelbine or anti-HER2 TKI drugs; Allergies to any compounds of experimental drugs; CNS disorders or mental disorders, history of clear neurological or mental disorders, including epilepsy or dementia; Other malignancies within 5 years, except cured in-situ of uterine cervix carcinoma , skin basal cell carcinoma and squamous-cell carcinoma. Any other situations judged by investigator as not suitable for participating in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 plus Vinorelbine<br> | Drug: Pyrotinib Plus Vinorelbine<br>* Pyrotinib: 320mg/d, q.d., p.o. A course of treatment need 21 days. Vinorelbine: 60mg/m2 q.d. d1,8,15, p.o. A course of treatment need 21 day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) of CNS | ORR, defined as proportion of complete response and partial response according to RANO-Brain Metastases (RANO-BM) criteria. | Estimated up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression (TTP) | TTP, defined as the time from the date of informed consent until the date of disease progression (PD), either CNS PD or extracranial PD, whichever comes first. | Estimated up to 1 year | 
| OS (overall survival) | OS, defined as the time from the date of informed consent until to the date of death, regardless of the cause of death. | Estimated up to 1 year | 
| Time to radiotherapy | Time to radiotherapy, defined as the time from the date of informed consent until to the date of radiotherapy. | Estimated up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Brain metastases, Pyrotinib, Vinorelbine, HER2