Axillary Surgery De-escalation After Neoadjuvant Therapy Using Dedicate Breast PET
- Conditions
- Breast Cancer
- Interventions
- Procedure: axillary surgery de-escalation after NAT
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Observation group( Axillary surgical evaluation is spared) axillary surgery de-escalation after NAT Breast cancer patients with initial axillary metastasis（T1-3N1-3M0） who are preparing for neoadjuvant therapy(NAT)，including neoadjuvant chemotherapy, targeted therapy, immunotherapy, etc. will received imaging examination（MRI、mammography、ultrasonography）at baseline and after every two cycles of NAT before surgery, dedicated breast/lymph positron emission tomography(DB/L-PET) at baseline and after first 1-2 cycle of NAT. We have developed a prediction model, which includes clinical parameters, pathological parameters, imaging examination parameters and DB/L-PET to predict the probability of complete pathological remission of axillary lymph nodes after receiving NAT. If the probability is more than 90%, the process of axillary surgical evaluation will be spared. If the probability is 50% -90%, Sentinel lymph node biopsy will be performed. If the probability is less than 50%, standard axillary lymph node dissection will be performed.
- Primary Outcome Measures
Name Time Method Node Recurrence Rate 2 years a recurrence in the ipsilateral axillary, supraclavicular, or internalmammary nodal basins.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fudan University Shanghai Cancer Center Shanghai, China, 200032
🇨🇳Shanghai, Shanghai, China