The Efficacy of Combined Peripheral Blood CTCs and Serum HER2 Detection in Docetaxel-based Treatment for HER2 Low-expression Breast Cancer

Starting soon

Conditions studied: Patients With Low HER2 Expression (IHC 1+ or IHC 2+/ISH-) and HER2 IHC 0 Advanced Breast Cancer

In brief

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.

Key facts

Study ID

NCT07670182

Run by

Tianjin Medical University Cancer Institute and Hospital

People needed

100

Starts

2026-06-15

Expected to finish

2031-01-01

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients with a pathological record of breast cancer;
• Group A: Diagnosed with low expression of HER2 (IHC 1+ or IHC 2+ and ISH-); Group B: Diagnosed with HER2 0 expression (IHC 0);
• No history of other malignant tumors;
• Signed the informed consent form at the age of 18 or above;
• Possess relatively complete clinical case characteristic data.

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

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