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NOT YET RECRUITING
NCT07527806
PHASE2

Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET/CT Molecular Imaging

Sponsor: Peking University Cancer Hospital & Institute

View on ClinicalTrials.gov

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

DRUG

Trastuzumab (Herceptin)

8 mg/kg first dose, followed 6 mg/kg given into the vein (IV; intravenously) every 21 days

DRUG

Pertuzumab

840 mg first dose, followed 420 mg given by IV every 21 days

DRUG

Combination product: Trastuzumab + Pertuzumab

600 mg Pertuzumab, 600 mg Trastuzumab, and 20,000 units hyaluronidase will be given by subcutaneous injection every 21 days

DRUG

Docetaxel or Nab-paclitaxel

Docetaxe 75mg/m²/ Nab-paclitaxel:260mg/m²

DRUG

carboplatin

AUC6

DRUG

CDK4/6 inhibitor

Ribociclib 600mg once daily every 21days/ Dalpiciclib 150mg once daily every 21days/ Palbociclib 125mg once daily every 21days

DRUG

Aromatase Inhibitor (AI)

Letrozole 2.5mg once daily/ Anastrozole 1mg once daily/ Exemestane25mg once daily

DRUG

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