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Trial Title:
HER2 Expression of CTC to Predict Response in HER2-low Advanced Breast Cancer Patients Treated With ADC
NCT ID:
NCT05834699
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Biological
Intervention name:
HER2 expression of circulating tumor cells
Description:
Detect HER2 expression of circulating tumor cells dynamically during ADC-based treatment
in HER2-low ABC
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
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Has pathologically documented breast cancer that:
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 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
Gender:
Female
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Fifth Medical Center of PLA General Hospital
Address:
City:
Beijing
Zip:
100071
Country:
China
Status:
Recruiting
Contact:
Last name:
Tao Wang
Phone:
01066947250
Email:
wangtaotg@163.com
Start date:
January 1, 2023
Completion date:
April 2025
Lead sponsor:
Agency:
Beijing 302 Hospital
Agency class:
Other
Source:
Beijing 302 Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05834699
