SHR-A1811 for HER2-positive Breast Cancer With Suboptimal Neoadjuvant Response (NCT07129187) | Clinical Trial Compass
Not Yet RecruitingPhase 2
SHR-A1811 for HER2-positive Breast Cancer With Suboptimal Neoadjuvant Response
30 participantsStarted 2025-10
Plain-language summary
This is an open-label, single-arm, multicenter clinical study to evaluate the efficacy and safety of SHR-A1811 in early or locally advanced HER2-positive breast cancer patients with suboptimal response to neoadjuvant regimen. Patients who were determined by the researchers to have poor therapeutic effect will switch to SHR-A1811.
Who can participate
Age range18 Years – 70 Years
SexFEMALE
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Inclusion Criteria:
* 1.Female patients with newly diagnosed breast cancer aged 18 to 70 years old;
* 2.Early or locally advanced HER2-positive invasive breast cancer;
* 3.Known hormone receptor status;
* 4.ECOG score of 0-1;
* 5.Patients who were determined by the researchers to have poor therapeutic effect after 4 cycles of neoadjuvant therapy;
* 6.Organ function levels must meet the following requirements:
* 7.Women of childbearing age must undergo a serum pregnancy test within 7 days before enrollment, with a negative result, and be willing to use a medically approved highly effective contraceptive method during the study and within 3 months after the last administration of the study drug.
* 8.The subjects voluntarily participate in this study and sign the informed consent form.
Exclusion Criteria:
* 1\. Patients with metastatic or bilateral breast cancer, or inflammatory breast cancer
* 2\. Patients with grade 3 or higher thrombocytopenia during previous treatment, or grade 3 or higher nausea and vomiting despite primary prevention
* 3\. History of other malignant tumors (except cured carcinoma in situ of the cervix, basal cell carcinoma, etc.) and related treatment history
* 4\. Patients who received major non-breast cancer surgery within 4 weeks before enrollment and have not recovered (except biopsy and PICC)
* 5\. Autoimmune diseases (except special cases such as hypothyroidism and stable type 1 diabetes)
* 6\. Interstitial lung disease, non-infectious pneumonia, …