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Several researches have proved that avoiding axillary surgery does not worsen the outcome of breast cancer patients with relatively low risk. Based on the routine axillary imaging evaluation (ultrasound and MR etc.) and latest dedicate lymph node PET (LymphPET), axillary nodal burden can be identified before operation.
Therefore this prospective study are designed to evaluate the negative predictive value of LymphPET and to verify whether sentinel lymph node biopsy can be spared in patients with negative preoperative axillary assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation group( SLNB is spared) | Experimental | In the second stage, sentinel lymph node biopsy will be spared in the patients with negative preoperative axillary assessment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SLNB is spared | Procedure | SLNB is spared in patients with negative preoperative axillary assessment(including LymphPET and other imaging examinations) |
|
| Measure | Description | Time Frame |
|---|---|---|
| stage 1: negative predictive value | negative predictive value of LymphPET in breast cancer patients with a negative preoperative axillary assessment | 6 months |
| stage 2: D-DFS(distant disease-free survival) | D-DFS of patients with negative preoperative axillary assessment(including LymphPET and other imaging examination) and for whom axillary surgery is spared | 5 years |
| stage 2: LRFS(local-regional free survival) | LRFS of patients with negative preoperative axillary assessment(including LymphPET and other imaging examination) and for whom axillary surgery is spared | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| stage 1: false negative rate | false negative rate of LymphPET in breast cancer patients with a negative preoperative axillary assessment | 6 months |
| stage 2: DFS(disease-free survival) | DFS of patients with negative preoperative axillary assessment(including LymphPET and other imaging examination) and for whom axillary surgery is spared |
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Inclusion Criteria:
stage 1:
stage 2:
Exclusion Criteria:
stage 1:
stage 2:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhi-Min Shao | Contact | 086-021-64175590 | zhimingshao@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhi-Min Shao | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41760969 | Derived | Qu FL, Cheng JY, Jiang SH, Zhang Q, Liu GY, Cao AY, Wu J, Yu KD, Di GH, Li JJ, Shao ZM. Omission of Axillary Surgery in Patients with Negative Axillary Evaluation Integrated with LymphPET: A Prospective Clinical Study. Ann Surg Oncol. 2026 Jun;33(6):5558-5566. doi: 10.1245/s10434-026-19342-5. Epub 2026 Feb 27. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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In the first stage, the negative predictive value is evaluated in patients with negative preoperative axillary assessment, including LymphPET and routine imaging examinations. In the second stage, sentinel lymph node biopsy will be spared in the patients with negative preoperative axillary assessment.
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| 5 years |
| stage 2: OS(overall survival) | OS of patients with negative preoperative axillary assessment(including LymphPET and other imaging examination) and for whom axillary surgery is spared | 5 years |
| stage 2: adverse events of upper limbs | adverse events of patients with negative preoperative axillary assessment(including LymphPET and other imaging examination) and for whom axillary surgery is spared，as assessed by CTCAE v5.0 | 5 years |
| stage 2: breast self evaluation | breast self evaluation for patients with negative preoperative axillary and for whom axillary surgery is spared, as assessed by BREAST Q© index. The BREAST-Q has a modular, procedure-specific structure with scales that evaluate both satisfaction and quality of life. Psychometric evaluation reveals high reliability, validity and responsiveness to surgical intervention across all scales. Breast Q is composed of aesthetical and emotional modules, and each score ranges from 1 to 4 points (higher values represent a better self evaluation). By comparing the sum of the score in different modules before and after the surgery, Breast Q can help to facilitate a self evaluation for breast cancer patients. | 5 years |
| D017437 |
| Skin and Connective Tissue Diseases |