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

Not Applicable

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT05914402
• Lead Sponsor: Fudan University

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-11
• Study First Submitted QC: 2023-06-13
• Last Update Submitted: 2023-06-13
• Study Start: 2023-06-18
• Study First Posted: 2023-06-22
• Last Update Posted: 2023-06-22
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Node Recurrence Rate	2 years	a recurrence in the ipsilateral axillary, supraclavicular, or internalmammary nodal basins.

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center Shanghai, China, 200032; 🇨🇳 Shanghai, Shanghai, China