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
60 participants
INTERVENTIONAL
2024-02-01
2026-12-31
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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Pyrotinib-initiated arm
two cycles of docetaxel + trastuzumab + pyrotinib followed by two cycles of docetaxel + trastuzumab + pertuzumab
pyrotinib
pyrotinib 320mg p.o. qd
pertuzumab
pertuzumab ivgtt q3w, 840mg for initiation, 420mg for maintenance
trastuzumab
trastuzumab ivgtt q3w, 8mg/kg for initiation, 6mg/kg for maintenance
docetaxel
docetaxel ivgtt q3w, 80-100mg/m2
Pertuzumab-initiated arm
four cycles of docetaxel + trastuzumab + pertuzumab
pertuzumab
pertuzumab ivgtt q3w, 840mg for initiation, 420mg for maintenance
trastuzumab
trastuzumab ivgtt q3w, 8mg/kg for initiation, 6mg/kg for maintenance
docetaxel
docetaxel ivgtt q3w, 80-100mg/m2
Interventions
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pyrotinib
pyrotinib 320mg p.o. qd
pertuzumab
pertuzumab ivgtt q3w, 840mg for initiation, 420mg for maintenance
trastuzumab
trastuzumab ivgtt q3w, 8mg/kg for initiation, 6mg/kg for maintenance
docetaxel
docetaxel ivgtt q3w, 80-100mg/m2
Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Intact renal, hepatic, bone marrow and cardiac functions including baseline left ventricular ejection fraction (LVEF) ≥ 55% measured by echocardiography
* No prior treatment
Exclusion Criteria
* History of other malignancies
* Severe cardiovascular disease
* Allergic to any of the regimens
18 Years
70 Years
FEMALE
No
Sponsors
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Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Kunwei Shen
Professor
Locations
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Ruijin Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RJBC2401
Identifier Type: -
Identifier Source: org_study_id
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