Breast Cancer
Conditions
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
Interventions
Detect HER2 expression of circulating tumor cells dynamically during ADC-based treatment in HER2-low ABC
Sponsors
Beijing 302 Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactJinmei Zhou, Doctor
Backup ContactJinyi Xiao, Doctor
Outcome results
None listed