NCT07393425

Neoadjuvant Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab in HER2+ Breast Cancer

Neoadjuvant Therapy With Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab or Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab Sequenced With Paclitaxel-based Regimens + Trastuzumab + Pyrotinib in HER2+ Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Patients with Stage II-III HER2-positive breast cancer will receive three cycles of treatment with Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab, followed by imaging assessment. If clinical complete response (cCR) or radiological complete response/near radiological complete response (rCR/near rCR) is achieved, they will continue to receive an additional three cycles of treatment with Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab, followed by surgery. If cCR/rCR or near rCR is not achieved, the treatment will be switched to the THPy regimen (paclitaxel-based regimen + Trastuzumab + Pyrotinib) for three cycles.

Conditions

• HER2 + Breast Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab Deruxtecan	4.8mg/kg, d1, q3w
DRUG	Pertuzumab	840mg on cycle1, 420mg on following cycles, d1, q3w
DRUG	Taxane Chemotherapy	Nab-paclitaxel 100 mg per square meter, d1,d8,d15 q3w Or Paclitaxel 80mg per square meter, d1,d8,d15 q3w Or Docetaxel 100mg per square meter, d1 q3w
DRUG	Trastuzumab (or biosimilar)	Trastuzumab 8mg/kg (loading dose) or 6mg/kg on following cycles, d1, q3w
DRUG	Pyrotinib 320mg	320mg qd

Timeline

• Start date: 2026-02-02
• Primary completion: 2027-09-30
• Completion: 2032-09-30
• First posted: 2026-02-06
• Last updated: 2026-02-06

Locations

1 site across 1 country: China