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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial population

This study focused on breast cancer patients who had received treatment with anti-HER2-ADC drugs.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Anti-HER2-ADC drug Deruxtepracabine

    Drug

    By monitoring the levels of CTCs/CTECs and serum HER2 expression in breast cancer patients receiving anti-HER2-ADC treatment during the treatment process, we aim to determine the therapeutic monitoring value of CTCs/CTECs and serum HER2 in these breast cancer patients using anti-HER2-ADC drugs.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Low expression of HER21 intervention

Trial outcomes

Primary outcomes

1

Evaluate the correlation between the HER2 expression status of baseline CTCs/CTECs and the overall response rate (ORR) of the entire population.

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.

Time frame
through study completion, an average of 2 year

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: