SHR-A1811 for HER2-positive Breast Cancer With Suboptimal Neoadjuvant Response
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorChuan Wang
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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)
Trial design
Treatments tested in this trial
- SHR-A1811
Treatment groups
30 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Chuan Wang
Lead sponsor
Fujian Medical University Union Hospital
Sponsor institution
Source ClinicalTrials.gov