Pyrotinib Plus Fulvestrant in Patients With HR+/HER2+ Metastatic Breast Cancer (Pyrotinib+Fulvestrant )

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, single-center clinical study of pyrotinib plus fulvestrant as the therapy HR+/HER2+ metastatic breast cancer.

Official Title
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Pyrotinib Plus Fulvestrant in Patients HR+/HER2+ Metastatic Breast Cancer : a Prospective, Single-arm, Single-center Study

Conditions
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Breast Cancer, HER2-positive Breast Cancer

Intervention / Treatment
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* Drug: Pyrotinib Plus Fulvestrant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 18-75 years old; HR positive and HER2 positive (immunohistochemistry or FISH test confirmed). ECOG score ≤ 2, expected survival ≥ 3 months. Histology or cytology confirmed as breast cancer. Prior to trastuzumab and endocrine therapy and progression/recurrence. At least one RECIST 1.1 defined measurable lesions. Normal function of major organs. Exclusion Criteria: pregnant or lactating women Patients who have relapsed or progressed within 12 months of end of adjuvant or neoadjuvant therapy, including chemotherapy, target therapy (eg lapatinib， trastuzumab), or other anti-tumor therapy. Except for endocrine therapy. Severe chronic gastrointestinal diseases with diarrhea as the main symptom (such as Crohn's disease, malabsorption, or ≥2 grade diarrhea caused by any cause at baseline). Rapid progress of organ invasion (such as liver and lung disease greater than 1/2 organ area or liver dysfunction, etc.) Patients with central nervous system disorders or mental disorders Bone metastasis lesions only, no other measurable lesions. Hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg) without ideal control. Uncontrolled heart disease. Have congenital long or short QT syndrome or have a family history or personal history of Brugada syndrome. Uncontrolled rain metastasis.

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 Fulvestrant<br> | Drug: Pyrotinib Plus Fulvestrant<br>* Pyrotinib: 400 mg/d, q.d., p.o. A course of treatment need 28 days. Fulvestrant: 500 mg/m2 q.d. i.m. A course of treatment need 28 day. First course needs extra dose of fulvestrant 500 mg/m2 q.d. i.m. on day 15.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) | Defined as the time from the date of informed consent to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first. | Estimated up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS (overall survival) | 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 | 
| Objective Response Rate (ORR) | Defined as proportion of complete response and partial response according to RECIST 1.1 criteria. | Estimated up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic Breast Cancer, Pyrotinib, Fulvestrant