NCT05914402

Axillary Surgery De-escalation After Neoadjuvant Therapy Using Dedicate Breast PET

Axillary Surgery De-escalation After Neoadjuvant Therapy (NeoaPET) Using a Dedicated Breast PET-based Pathological Response-adapted Strategy in Patients With Axillary-positive Early Breast Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Some breast cancer patients with initial axillary metastasis can achieve axillary complete pathological remission(A-pCR) after neoadjuvant therapy(NAT)，These patients are candidates for axillary Surgery de-escalation. This prospective study is designed to evaluate the feasibility and safety of axillary surgery de-escalation for the initial axillary metastasis breast cancer patients who are predicted to achieve A-pCR using multiple pathological indicators and imaging examinations (molecular typing, ultrasound and dedicated breast positron emission tomography, etc.) before and after 1-2 cycles NAT

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	axillary surgery de-escalation after NAT	the process of axillary surgical evaluation will be spared after NAT using the prediction model if the probability is more than 90%.

Timeline

• Start date: 2023-06-18
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-06-22
• Last updated: 2023-06-22

Locations

1 site across 1 country: China