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NCT07670182Not yet recruiting

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 · Last updated 26 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
100 (estimated)
First submitted
8 Jun 2026
Start date
Jun 2026
Primary completion date
Oct 2030
Lead sponsor
Tianjin Medical University Cancer Institute and Hospital
NCT number
NCT07670182

What you commit to

  • Study type: Observational
  • Planned participants: 100
  • From Jun 2026 to the primary completion date, Oct 2030
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.