Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer
NCT ID: NCT07180082
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
186 participants
INTERVENTIONAL
2025-08-28
2029-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intermittent pyrotinib
Intermittent use of pyrotinib, 14 days on and 7 days of, every 21 days
Pyrotinib
anti-HER2 tyrosine kinase inhibitor
Continuous pyroitnib
oral pyrotinib qd
Pyrotinib
anti-HER2 tyrosine kinase inhibitor
Interventions
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Pyrotinib
anti-HER2 tyrosine kinase inhibitor
Eligibility Criteria
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Inclusion Criteria
* Pathologically confirmed advanced or locally advanced breast cancer not amenable to curative surgery
* Pathologically confirmed HER2+ at least once for either primary or metastatic lesion
* Previously treated with any number of lines for advanced disease and eligible for a pyrotinib-containing regimen at the discretion of physician
* At least one measurable lesion or bone-only disease (osteolytic or mixed) according to RECIST v1.1
* ECOG 0-1
* Adequate organ function
Exclusion Criteria
* Difficulties with pyrotinib administration or absorption
18 Years
ALL
No
Sponsors
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Wenjin Yin
OTHER
Responsible Party
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Wenjin Yin
Deputy Chief of Breast Surgery Department
Principal Investigators
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Wenjin Yin, M.D.
Role: PRINCIPAL_INVESTIGATOR
Renji Hospital,School of Medicine, Shanghai Jiaotong University
Locations
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Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, , China
Countries
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Central Contacts
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Yin
Role: CONTACT
Facility Contacts
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Other Identifiers
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LY2025-118-A
Identifier Type: -
Identifier Source: org_study_id
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