HER2 Expression of CTC to Predict Response in HER2-low Advanced Breast Cancer Patients Treated With ADC
An Exploratory Clinical Study of HER2 Expression of Circulating Tumor Cells : Predictive and Prognostic Value in HER2-low Advanced Breast Cancer Patients Treated With ADC
1 other identifier
observational
50
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2023
CompletedFirst Submitted
Initial submission to the registry
April 18, 2023
CompletedFirst Posted
Study publicly available on registry
April 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2025
CompletedApril 28, 2023
April 1, 2023
1.9 years
April 18, 2023
April 18, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Progression free survival(PFS)
PFS was defined as the time from the start of treatment to either the first documented disease progression or death from any cause
3 years
Secondary Outcomes (2)
Objective response rate (ORR)
2years
Overall survival(OS)
5 years
Interventions
Detect HER2 expression of circulating tumor cells dynamically during ADC-based treatment in HER2-low ABC
Eligibility Criteria
Patients diagnosed with HER2-low breast cancer (according to International Classification of Diseases-10, ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.
You may qualify if:
- Has pathologically documented breast cancer that:
- Is unresectable or metastatic
- Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested)
- Has progressed on, and would no longer benefit from, endocrine therapy
- 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
You may not qualify if:
- Has breast cancer ever assessed with high-HER2 expression
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 100071, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tao Wang
Beijing 302 Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2023
First Posted
April 28, 2023
Study Start
January 1, 2023
Primary Completion
December 1, 2024
Study Completion
April 1, 2025
Last Updated
April 28, 2023
Record last verified: 2023-04