A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer

Study Overview
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Brief Summary
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This is a randomised, double-blind multicenter Phase III study for evaluating the efficacy and safety of pyrotinib in women with early stage high-risk breast cancer after adjuvant trastuzumab. The main purpose of this study is to investigate whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.

Official Title
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A Phase III Study to Evaluate the Efficacy and Safety of Pyrotinib Versus Placebo in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Early or Locally Advanced Breast Cancer After Adjuvant Trastuzumab

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Pyrotinib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients, 18 years ≤ age ≤ 75 years； Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1 Histologically confirmed invasive HER2 positive breast cancer. Known hormone receptor status. Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by Echocardiogram. Been treated for early breast cancer with standard of care duration of trastuzumab. If been not treated neoadjuvantly, lymph node metastases need to be confirmed by postoperative pathology; if been treated neoadjuvantly , have not reached totally pathologic complete response. Signed informed consent form (ICF) . Exclusion Criteria: Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry. History of heart disease. Bilateral breast cancer. Corrected QT (QTc) interval ≥0.47 seconds. 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pyrotinib versus Placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm Pyrotinib<br>Intervention: Drug: Pyrotinib | Drug: Pyrotinib<br>* pyrotinib 400 mg, orally once daily for one year<br>|
| Placebo Comparator: Arm Placebo<br>Intervention: Drug: Placebo | Drug: Placebo<br>* placebo 400mg, orally once daily for one year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Invasive Disease-free Survival (iDFS) | Invasive disease-free survival time is defined as the time from date of randomization until the first invasive disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause. | From randomization until time of event up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free Survival (DFS) | Disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, non-breast primary invasive cancer, ductal carcinoma in situ(DCIS),or distant recurrence and death from any cause. | From randomization until time of event up to 2 years | 
| Overall Survival (OS) | Overall survival is defined as the time from randomization to death from any cause. | up to 2 years | 
| Distance Disease-free Survival (DDFS) | Distance Disease-free Survival is defined as the time from date of randomization until the first distant recurrence and death from any cause. | distant recurrence From randomization until time of event up to 2 years |