HER2 Expression of CTC to Predict Response in HER2-low Advanced Breast Cancer Patients Treated With ADC
Study Details
Study Description
Brief Summary
To evaluate the predictive and prognostic value of HER2 expression of circulating tumor cells in HER2-low advanced breast cancer patients treated with ADC
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
- Progression free survival(PFS) [3 years]
PFS was defined as the time from the start of treatment to either the first documented disease progression or death from any cause
Secondary Outcome Measures
- Objective response rate (ORR) [2years]
ORR was defined as the proportion of patients with a complete response or a partial response.
- Overall survival(OS) [5 years]
OS was defined as the time from the start of treatment to death from any cause
Eligibility Criteria
Criteria
Inclusion Criteria:
- Has pathologically documented breast cancer that:
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Is unresectable or metastatic
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Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested)
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Has progressed on, and would no longer benefit from, endocrine therapy
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Has been treated at least 1 prior line of chemotherapy in the metastatic setting
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Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions
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Receives anti-HER2 ADC treatment
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Life expectancy > 3 months
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Evidence of measurable or evaluable disease (RECIST 1.1 criteria)in the 28 days before selection
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ECOG ≤2
Exclusion Criteria:
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Has breast cancer ever assessed with high-HER2 expression
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Has previously been treated with any anti-HER2 therapy, including an antibody drug conjugate
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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
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Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | The Fifth Medical Center of PLA General Hospital | Beijing | Beijing | China | 100071 |
Sponsors and Collaborators
- Beijing 302 Hospital
Investigators
- Study Director: Tao Wang, Beijing 302 Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Breast-CTC-HER1