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NCT07670182
The Efficacy of Combined Peripheral Blood CTCs and Serum HER2 Detection in Docetaxel-based Treatment for HER2 Low-expression Breast Cancer
Conditions: Patients With Low HER2 Expression (IHC 1+ or IHC 2+/ISH-) and HER2 IHC 0 Advanced Breast Cancer
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 100
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Summary
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07670182). StuddyBuddy aggregates publicly available trial information.