HER2 Expression of CTC to Predict Response in HER2-low Advanced Breast Cancer Patients Treated With ADC
NCT ID: NCT05834699
Last Updated: 2023-04-28
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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UNKNOWN
50 participants
OBSERVATIONAL
2023-01-01
2025-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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HER2 expression of circulating tumor cells
Detect HER2 expression of circulating tumor cells dynamically during ADC-based treatment in HER2-low ABC
Eligibility Criteria
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Inclusion Criteria
1. Is unresectable or metastatic
2. Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested)
3. Has progressed on, and would no longer benefit from, endocrine therapy
4. Has been treated at least 1 prior line of chemotherapy in the metastatic setting
* Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions
* Receives anti-HER2 ADC treatment
* Life expectancy \> 3 months
* Evidence of measurable or evaluable disease (RECIST 1.1 criteria)in the 28 days before selection
* ECOG ≤2
Exclusion Criteria
* Has previously been treated with any anti-HER2 therapy, including an antibody drug conjugate
* Has history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
* Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study
FEMALE
No
Sponsors
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Beijing 302 Hospital
OTHER
Responsible Party
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Principal Investigators
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Tao Wang
Role: STUDY_DIRECTOR
Beijing 302 Hospital
Locations
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The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Tao Wang
Role: primary
Other Identifiers
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Breast-CTC-HER1
Identifier Type: -
Identifier Source: org_study_id