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According to the standard treatment guidelines established until recently, in the case of ipsilateral breast tumor recurrence without systemic metastasis, salvage mastectomy or lumpectomy can be performed when either partial or whole breast radiation therapy is possible. On the other hand, there are currently no standard treatment guidelines for axillary treatment, and the evidence for this is limited. Axillary lymph node metastasis was reported to occur in about 26% of breast cancer patients who had negative sentinel lymph nodes from previous surgery for primary breast cancer and only local recurrence occurred. It is still important in the decision of treatment or adjuvant radiation therapy. However, it is known that most of the patients with ipsilateral breast recurrence do not have axillary lymph node metastasis. Therefore, performing axillary axillary surgery in all of these patients does not help the patient's survival in many cases, but rather can lead to complications such as lymphedema and seroma and postoperative wound infection. A question about the implementation of axillary lymph node resection has been raised and for this reason, it is necessary to study whether surveillance lymph node biopsy is still effective in patients with recurrence in the ipsilateral breast.
Most of the studies on ipsilateral breast tumor recurrence without systemic metastasis reported to date are case reports or small retrospective studies. In addition, the combined meta-analysis also has limitations in that the study design is not uniform, and there are many cases in which primary breast cancer surgery performed total mastectomy or axillary lymph node dissection. This study is a multicenter prospective study designed to validate the clinical effectiveness of repeat-SLNB conducted in patients with ipsilateral breast tumor recurrence among patients who previously underwent breast conservation and sentinel lymph node biopsy for unilateral primary breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| reSLNB arm | Experimental | repeat SLNB procedure is performed in when the patient is diagnosed with ipsilateral breast tumor recurrence, who had undergone partial mastectomy and sentinel lymph node biopsy for primary operation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| reSLNB arm | Procedure | Radioisotope, blue dye, dual mapping methods are all allowed for re-SLNB mapping. Positive finding in re-SLNB is defined according to AJCC 8th edition, as micrometastasis or macrometastasis. Isolated tumor cell is considered negative. When sentinel lymph node is not identified, axillary operation is via physician's choice. When re-SLNB finding is negative, no further axillary lymph node dissection is performed. If there is node metastasis from re-SLNB, axillary lymph node dissection or radiation therapy can be performed as in physician's choice. |
| Measure | Description | Time Frame |
|---|---|---|
| 5 year disease free survival | To prove non-inferiority of re-SLNB compared to ALND regarding disease free survival | 5 years after surgery (re-SLNB) |
| Measure | Description | Time Frame |
|---|---|---|
| identification rate of sentinel lymph node | identification rate of sentinel lymph node | 5 years after surgery |
| 5-year overall survival | 5-year overall survival |
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Inclusion Criteria:
Exclusion Criteria:
5) Pregnant and lactating patients
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soong June Bae, M.D. | Contact | 82-2-2019-4401 | mission815815@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Joon Jeong | Gangnam Severance Hospital, Yonsei University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gangnam Severance Hospital, Yonsei University College of Medicine | Recruiting | Seoul | 06273 | South Korea |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| 5 years after surgery |
| 5-year local recurrence free survival | 5-year local recurrence free survival | 5 years after surgery |
| 5-year regional recurrence free survival | 5-year regional recurrence free survival | 5 years after surgery |
| 5-year distant metastasis free survival | 5-year distant metastasis free survival | 5 years after surgery |
| survival by adjuvant treatment | survival analysis according to the adjuvant treatment after secondary surgery | 5 years after surgery |
| survival by tumor subtype | survival analysis by tumor subtype | 5 years after surgery |
| identification rate of sentinel lymph node by tumor location | identification rate of sentinel lymph node according to the location of primary tumor(caudal/non-caudal) | 5 years after surgery |
| 5-year DFS by tumor location | 5-year DFS accoridng to the location of primary tumor (caudal/non-caudal) | 5 years after surgery |
| D017437 |
| Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |