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SHR-A1811 Plus Pertuzumab in the Neoadjuvant Treatment of HER2 Positive BC

StatusRecruiting
PhasePhase 2
Started2025-04-16
View on ClinicalTrials.gov ↗

Amendment history

2025-06-20
notable
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations, IPDSharing v1
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2025-04-13
minor
Original filing
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 1:SHR-A1811 combined with pertuzumab for 6 cycles; * cohort 2:SHR-A1811 combined with pertuzumab and albumin-paclitaxel for 6 cycles; * cohort 3:TCbHP (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.
Trial Details
NCT Number NCT06927180
Lead Sponsor Henan Cancer Hospital
Conditions Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Enrollment 180 participants
Start Date 2025-04-16
Primary Completion 2029-05-01 (estimated)
Study Completion 2030-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-06-23