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
NA
36 participants
INTERVENTIONAL
2023-05-04
2026-08-31
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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RC48-ADC
RC48-ADC as salvage treatment for HER2-low advanced breast cancer
Disitamab vedotin
2.0mg/kg, iv, day1, every 2 weeks
Interventions
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Disitamab vedotin
2.0mg/kg, iv, day1, every 2 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Expected survival ≥12 weeks
* ECOG 0-1
* Histologically confirmed invasive advanced or metastatic breast cancer that is incurable and unresectable
* At least one measurable lesion according to the RECIST 1.1
* No history of antibody-drug conjugate use
* Up to one previous chemotherapy for advanced disease
* Available hormone receptor status. Hormone receptor-positive subjects are allowed to receive no more than two previous endocrine therapy for advanced disease
* HER2-low tumors, defined as IHC1+ or IHC2+ with negative FISH test; or HER2-ultralow tumors, defined as incomplete and faint membrane staining in \>0 but ≤10% of tumor cells
* Adequate organ function
Exclusion Criteria
* Uncontrolled systemic diseases, including diabetes, hypertension, interstitial lung disease, cirrhosis, etc.
* Active infections requiring systemic treatment
* Pregnant or lactating
* Presence of brain metastases and/or carcinomatous meningitis
18 Years
FEMALE
No
Sponsors
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RenJi Hospital
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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Facility Contacts
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Other Identifiers
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LY2023-054-B
Identifier Type: -
Identifier Source: org_study_id
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