Pyrotinib in Women With High-risk in Early Stage Breast Cancer

Study Overview
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Brief Summary
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ExteNET study explored neratinib prolong anti-HER2 therapy after trastuzumab therapy found that it can improve disease-free survival in patients with lymph nodes positive; In addition, the subgroup of patients with residual tumors after neoadjuvant therapy was found to improve the survival. However, no conclusive conclusions were reached. However, since the study was carried out early so only trastuzumab treatment was used, it is urgent to carry out research that is more in line with current clinical practice and bring more benefits to patients. To explore whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER2-positive breast cancer after treatment with trastuzumab and pertuzumab or T-DM1.

Official Title
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Evaluating the Efficacy and Safety of Pyrotinib After Adjuvant Anti-HRE2 Therapy in Women With High-risk in Early or Locally Advanced Stage Breast Cancer

Conditions
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HER2-positive Breast Cancer

Intervention / Treatment
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* Drug: Pyrotinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects voluntarily participate in this study and sign the informed consent form； Female or male patients, aged ≥ 18 years, and ≤75 years; ECOG PS score: 0-1; Patients with HER2+ early or locally advanced breast cancer confirmed by histopathology: HER2-positive is defined by standard of 3+ by immunohistochemical staining (IHC), or 2+ by immunohistochemical staining (IHC) but positive by in situ hybridization (ISH). Stage II through IIIC HER-2 positive breast cancer with node positive disease after surgery. Been treated for early breast cancer with standard of care duration of trastuzumab combined with pertuzumab or T-DM1. Could have been treated neoadjuvantly but have not reached pathologic complete response. Exclusion Criteria: metastatic disease (Stage IV) or inflammatory breast cancer Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix. Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110); A history of allergy to the drugs in this study； Unable or unwilling to swallow tablets History of gastrointestinal disease with diarrhea as the major symptom.

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<br>pyrotinib 400mg orally daily for one year | Drug: Pyrotinib<br>* Pyrotinib after anti-HER2 therapy（Trastuzumab combined with Pertuzumab or T-DM1）<br>* Other names: Pyrotinib maleate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Invasive Disease-free Survival (iDFS) at year 2 | Invasive disease-free survival time is defined as the time from date of enrollment until the first disease recurrence or death from any cause. | From enrollment until time of events up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free Survival at year 2 (2y-DFS) | Disease-free survival time is defined as the time from date of enrollment until the first disease recurrence（including carcinoma in situ）or death from any cause. | From enrollment until time of events up to 2 years | 
| Overall Survival (OS) | Randomization to death from any cause | Enrollment until death due to any cause, up to 10 years | 
| Invasive Disease-free Survival (iDFS) at year 5 | Invasive disease-free survival time is defined as the time from date of enrollment until the first disease recurrence or death from any cause. | From enrollment until time of events up to 5 years | 
| AEs and SAEs | Adverse events and Adverse events and serious adverse events according to CACTE 5.0 | From the first administration to one months after the last drug administration |