Clinical trial · Observational
HER2 Expression of CTC to Predict Response in HER2-positive Advanced Breast Cancer Patients Treated With ADC
An Exploratory Clinical Study of HER2 Expression of Circulating Tumor Cells : Predictive and Prognostic Value in HER2-positive Advanced Breast Cancer Patients Treated With ADC
NCT05834686CI-TRIAL-00066034unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the predictive and prognostic value of HER2 expression of circulating tumor cells in HER2-positive advanced breast cancer patients treated with ADC
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HER2 expression of circulating tumor cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression free survival(PFS)
- timeFrame
- 3 years
- description
- PFS was defined as the time from the start of treatment to either the first documented disease progression or death from any cause
Secondary outcomes (2)
- measure
- Objective response rate (ORR)
- timeFrame
- 2years
- description
- ORR was defined as the proportion of patients with a complete response or a partial response
- measure
- Overall survival(OS)
- timeFrame
- 5 years
- description
- OS was defined as the time from the start of treatment to death from any cause
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Has pathologically documented breast cancer that: 1. Is unresectable or metastatic 2. has confirmed HER2-positive expression defined as IHC 2+/ISH+ or IHC 3+ 3. was previously treated with trastuzumab and taxane in the advanced setting or progressed within 6 months after neoadjuvant or adjuvant treatment involving a regimen including trastuzumab and taxane * Has 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 uncontrolled or significant cardiovascular disease * 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
References
Publications (0)
Data not yet available
No reference posted for this study.