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Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET/CT Molecular Imaging
Sponsor: Peking University Cancer Hospital & Institute
Summary
This study evaluates HER2-PET/CT-guided dynamic optimization of neoadjuvant therapy in patients with early-stage HER2-positive breast cancer. Based on metabolic response after two cycles, patients receive either intenstified treatment (Arm A) or de-escalation treatment (Arm B), alongside with a concurrent standard-treatment control group (Arm C). The study aims to establish a response-adaptive, imaging-guided treatment paradigm to optimize neoadjuvant therapy in HER2-positive breast cancer.
Official title: A Prospective, Double-Arm Study on the Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET/CT Molecular Imaging
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
156
Start Date
2026-05-01
Completion Date
2029-12-31
Last Updated
2026-04-17
Healthy Volunteers
No
Conditions
Interventions
Trastuzumab (Herceptin)
8 mg/kg first dose, followed 6 mg/kg given into the vein (IV; intravenously) every 21 days
Pertuzumab
840 mg first dose, followed 420 mg given by IV every 21 days
Combination product: Trastuzumab + Pertuzumab
600 mg Pertuzumab, 600 mg Trastuzumab, and 20,000 units hyaluronidase will be given by subcutaneous injection every 21 days
Docetaxel or Nab-paclitaxel
Docetaxe 75mg/m²/ Nab-paclitaxel:260mg/m²
carboplatin
AUC6
CDK4/6 inhibitor
Ribociclib 600mg once daily every 21days/ Dalpiciclib 150mg once daily every 21days/ Palbociclib 125mg once daily every 21days
Aromatase Inhibitor (AI)
Letrozole 2.5mg once daily/ Anastrozole 1mg once daily/ Exemestane25mg once daily
ADC
T-Dxd: 5.4mg/kg given into the vein (IV; intravenously) every 21 days SHR-A1811: 4.8mg/kg given into the vein (IV; intravenously) every 21 days