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 volunteersQualifiers
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
Case-control
Prospective
Treatments tested in this trial
Anti-HER2-ADC drug Deruxtepracabine
DrugBy 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
Trial outcomes
Primary outcomes
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.
Locations
Sponsors and contacts
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