Short-course Trastuzumab, Pertuzumab with Taxanes in the Adjuvant Treatment of Early HER2-positive Breast Cancer
NCT ID: NCT05891561
Last Updated: 2024-11-27
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
120 participants
INTERVENTIONAL
2023-11-01
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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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pertuzumab
4 cycles of taxane, Pertuzumab, Trastuzumab
Pertuzumab
4 cycles of taxane, pertuzumab, trastuzumab
Interventions
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Pertuzumab
4 cycles of taxane, pertuzumab, trastuzumab
Eligibility Criteria
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Inclusion Criteria
* HER2-positive, ie. immunohistochemistry \[IHC\] 3+ or IHC 2+ and fluorescence in situ hybridisation \[FISH\]-positive according to ASCO/CAP 2018 guidelines
* complete clinical pathological information
* Eastern Cooperative oncology Group \[ECOG\] 0-1
* Currently not pregnant or breast-feeding
* Fine organ function
* Have good compliance with planned treatment, understand the study process and sign a written informed consent
Exclusion Criteria
* Receiving neoadjuvant treatment
* Other malignancies within 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer
* Severe systemic infections or other serious illnesses
* HIV infection, active hepatitis B or C infection
* Known allergy to or intolerance to a therapeutic drug or its excipients
* Prior history of chemotherapy, endocrine therapy, biotherapy, or radiation therapy for any reason
* Enrollment of another investigational study within 4 weeks prior to initial administration of the investigational treatment
* Receiving live vaccine within 30 days prior to initial administration of the investigational treatment
* History of mental illness or drug abuse that may affect compliance with the trial requirements
* The researchers determine that the patients were not suitable for the study
18 Years
75 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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Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Xiaosong Chen
Role: primary
Yiwei Tong
Role: backup
Other Identifiers
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RJBC-THP4
Identifier Type: -
Identifier Source: org_study_id