Clinical trial · Observational
The Efficacy of Combined Peripheral Blood CTCs and Serum HER2 Detection in Docetaxel-based Treatment for HER2 Low-expression Breast Cancer
A Prospective, Multicenter Clinical Study on the Efficacy Correlation of Deruxtepruzumab Treatment for Advanced Breast Cancer With Low/Ultra-low HER2 Expression, Guided by Peripheral Blood CTCs/CTECs Combined With Serum HER2 Detection
- 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)
This study is a multicenter, double-cohort clinical research aimed at systematically evaluating the value of jointly detecting the HER2 expression of CTCs/CTECs and the serum HER2 ECD level in predicting the efficacy of T-DXd treatment for patients with HER2 low expression (IHC 1+ or IHC 2+/ISH-) and HER2 IHC 0 advanced breast cancer.
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 |
|---|---|---|---|
| Patients With Low HER2 Expression (IHC 1+ or IHC 2+/ISH-) and HER2 IHC 0 Advanced Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-HER2-ADC drug Deruxtepracabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Low expression of HER2
- description
- Patients with low HER2 expression (IHC 1+ or IHC 2+/ISH-) and HER2 IHC 0 advanced breast cancer
- interventionNames
- Drug: Anti-HER2-ADC drug Deruxtepracabine
Primary outcomes (1)
- measure
- Evaluate the correlation between the HER2 expression status of baseline CTCs/CTECs and the overall response rate (ORR) of the entire population.
- timeFrame
- through study completion, an average of 2 year
- description
- Evaluate the correlation between the HER2 expression status of baseline CTCs/CTECs and the overall population's DCR, PFS, and OS. Evaluate the correlation between the baseline serum HER2 ECD level and the overall population's ORR, DCR, PFS, and OS.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with a pathological record of breast cancer; 2. Group A: Diagnosed with low expression of HER2 (IHC 1+ or IHC 2+ and ISH-); Group B: Diagnosed with HER2 0 expression (IHC 0); 3. No history of other malignant tumors; 4. Signed the informed consent form at the age of 18 or above; 5. Possess relatively complete clinical case characteristic data. Exclusion Criteria: * 1\. Male breast cancer patients; 2. Pregnant or breastfeeding; 3. Patients known to have an allergic reaction to the active substances or any excipients of T-DXd; 4. Patients judged by the investigators to be unsuitable to participate in this study.
References
Publications (0)
Data not yet available