Repeat Sentinel Lymph Node Biopsy in Ipsilateral Breast Tumor Recurrence

Официальное название

Repeat Sentinel Lymph Node Biopsy in Ipsilateral Breast Tumor Recurrence Without Distant Metastasis: A Single-arm, Multicenter, Prospective Study

Обзор

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.

Вмешательства

• Процедура reSLNB arm
  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

Первичные конечные точки

• 5 year disease free survival [Срок оценки: 5 years after surgery (re-SLNB)]

Вторичные конечные точки (9)

• identification rate of sentinel lymph node [Срок оценки: 5 years after surgery]
• 5-year overall survival [Срок оценки: 5 years after surgery]
• 5-year local recurrence free survival [Срок оценки: 5 years after surgery]
• 5-year regional recurrence free survival [Срок оценки: 5 years after surgery]
• 5-year distant metastasis free survival [Срок оценки: 5 years after surgery]
• survival by adjuvant treatment [Срок оценки: 5 years after surgery]
• survival by tumor subtype [Срок оценки: 5 years after surgery]
• identification rate of sentinel lymph node by tumor location [Срок оценки: 5 years after surgery]
• 5-year DFS by tumor location [Срок оценки: 5 years after surgery]

Критерии участия

Критерии включения

• Age over 19 years old
• Patients who are expected to undergo surgery under the diagnosis of ipsilateral breast tumor recurrence(histologically confirmed in situ disease or invasive disease)
• Patients who had partial mastectomy and sentinel lymph node biopsy for prior operation for the initially diagnosed breast cancer
• Patients considered to be axillary lymph node negative from clinical findings
• Patients who understand and willingly participate in the study

Критерии исключения

• Patients with recurrence in other regions. (e.g. ipsilateral axillary lymph node, supraclavicular lymph node, internal mammary lymph node, etc.)
• Patients who are not eligible to perform SLNB
• Patients who received mastectomy or axillary lymph node dissection for prior operation
• Patients who experienced recurrence within a year from the primary operation
• Patientes who are known to have axillary lymph node metastasis before the secondary operation, histologically confirmed from tissue biopsy or cytology
• Patients with systemic recurrence
• Patients with inflammatory breast cancer

5\) Pregnant and lactating patients

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Gangnam Severance Hospital, Yonsei University College of Medicine — Seoul

Идентификаторы

NCT: NCT04741737 · 3-2020-0448

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗