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

NCT07527806 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2026-04-17

No results posted yet for this study

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.

Conditions

Interventions

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

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

Sponsors & Collaborators

  • Peking University Cancer Hospital & Institute

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2029-05-01
Completion
2029-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07527806 on ClinicalTrials.gov