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This is a prospective, randomised, controlled, multicentre study to evaluate the efficacy and safety of continuous versus intermittent pyrotinib therapy in patients with human epidermal growth factor receptor (HER2)-positive advanced breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent pyrotinib | Experimental | Intermittent use of pyrotinib, 14 days on and 7 days of, every 21 days |
|
| Continuous pyroitnib | Active Comparator | oral pyrotinib qd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pyrotinib | Drug | anti-HER2 tyrosine kinase inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | ORR is the percentage of subjects with complete remission (CR) or partial remission (PR) as the best response during the period from the beginning of the treatment to the progression of the disease or the completion of therapy (CR+PR)/Analysis of the total number of people. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) was used to assess the objective tumor response. | From the date of starting pyrotinib to the date of confirmed CR or PR (up to approximately 1 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS is defined as the time from the date of starting maintenance therapy to the date of disease progression or death from any cause, whichever occurs first. | From the date of starting pyrotinib to the date of first documentation of disease progression or death from any cause (up to approximately 1 year) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenjin Yin, M.D. | Contact | 86(21)68385569 | yinwenjin@renji.com | |
| Yin | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Wenjin Yin, M.D. | Renji Hospital,School of Medicine, Shanghai Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital, School of Medicine, Shanghai Jiaotong University | Recruiting | Shanghai | 200127 | China |
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| ID | Term |
|---|---|
| C000622954 | pyrotinib |
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| Adverse events |
Adverse events during maintenance therapy 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) |