NCT06927180

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

SHR-A1811 Plus Pertuzumab in Combination With or Without Albumin-paclitaxel as Neoadjuvant Treatment for Early or Locally Advanced HER2-positive Breast Cancer：A Prospective, Randomized, Open-label, Phase II Trial.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Interventions

Type	Name	Description
DRUG	SHR-A1811	an anti-HER2 antibody-drug conjugate (ADC)
DRUG	Pertuzumab	Pertuzumab
DRUG	Albumin-Paclitaxel	Nab paclitaxel
DRUG	Docetaxel	Docetaxel
DRUG	Carboplatin	Carboplatin
DRUG	Trastuzumab	Trastuzumab

Timeline

• Start date: 2025-04-16
• Primary completion: 2029-05-01
• Completion: 2030-12-01
• First posted: 2025-04-15
• Last updated: 2025-06-23

Locations

1 site across 1 country: China