SHR-A1811 Plus Pertuzumab in the Neoadjuvant Treatment of HER2 Positive BC
Status:
RECRUITING
Trial end date:
2030-12-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to evaluate the efficacy and safety of SHR-A1811 plus pertuzumab in combination with or without albumin-paclitaxel neoadjuvant therapy for early or locally advanced HER2-positive breast cancer. The main questions it aims to answer are:
* Does the pCR of SHR-A1811 plus pertuzumab with or without albumin-paclitaxel improve compared to the current standard of treatment?
* Is the safety of SHR-A1811 plus pertuzumab with or without albumin-paclitaxel better compared to the current standard of treatment? Researchers will compare SHR-A1811+pertuzumab or SHR-A1811+pertuzumab+albumin-paclitaxel to TCbHP to see if SHR-A1811 plus pertuzumab with or without albumin-paclitaxel works to treat early or locally advanced HER2-positive breast cancer.
Subjects will be randomly assigned 1:1:1 to
* cohort 1SHR-A1811 combined with pertuzumab for 6 cycles;
* cohort 2SHR-A1811 combined with pertuzumab and albumin-paclitaxel for 6 cycles;
* cohort 3TCbHP (docetaxel, carboplatin, trastuzumab and pertuzumab) for 6 cycles.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.