Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer

Study Overview
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Brief Summary
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This is a prospective, randomised, controlled, multicentre study to compare the efficacy and safety between continuous or intermittent extension of adjuvant pyrotinib in invasive human epidermal growth factor receptor 2 (HER2)-positive breast cancer.

Official Title
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Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer: a Prospective, Randomised, Controlled, Multicentre Clinical Trial

Conditions
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Breast Cancer Invasive

Intervention / Treatment
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* Drug: pyrotinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥18 and ≤70 years; Histologically confirmed invasive HER2 positive breast cancer; Duration from random time to the last use of trastuzumab or T-DM1 ≤3 years; Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1; Adequate organ functions. Exclusion Criteria: Metastatic disease (Stage IV); Gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery; Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption; Treated or treating with anti-HER2 tyrosine kinase inhibitor; Less than 4 weeks from the last clinical trial; History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation; Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test; Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period; Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: continuous pyrotinib<br>pyrotinib 400 mg, orally once daily for one year | Drug: pyrotinib<br>* an irreversible anti-HER2 tyrosine kinase inhibitor<br>|
| Experimental: intermittent pyrotinib<br>pyrotinib 400 mg, 14 days on and 7 days off, every 21 days for 17 cycles | Drug: pyrotinib<br>* an irreversible anti-HER2 tyrosine kinase inhibitor<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. | From randomization until time of event up to 2 years | 
| Adverse events | Adverse events will be assessed according to the NCI CTCAE v5.0. | From the date of starting pyrotinib to the end of the treatment (up to approximately 1 year) |