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Refusal of Sentinel Lymph Node Biopsy in Patients With Luminal A Subtype Early Breast Cancer (LumiNOde)

2026년 5월 6일 업데이트: N.N. Petrov National Medical Research Center of Oncology

Sentinel lymph node biopsy (SLNB) is the standard of axillary lymph node surgical staging in patients with early breast cancer.

The main goal of the study is to abandon axillary surgery in patients over 59 years old with early, luminal A, clinical lymph node negative breast cancer.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

Sentinel lymph node biopsy (SLNB) has replaced axillary lymph node dissection (ALND) in early breast cancer and has been widely implemented in clinical practice worldwide. The primary goal of SLNB is to reduce the complications associated with ALND while maintaining high anti-tumor efficacy.

However, many studies have shown that although SLNB reduces the complications typical of ALND, the incidence of these complications remains high: the risk of developing lymphedema is 7.5%, sensory disturbances and restrictions in arm movement occur in 5-8% of cases. It is well known that these complications negatively affect the physical, psychological, and emotional well-being of women, thereby reducing their quality of life.

It is also noteworthy that there is a relatively high rate of false-negative results in SLNB (ranging from 4.6% to 16.7%).

Due to advances in imaging diagnostic methods, the accuracy of preoperative assessment of lymph node status has significantly improved. According to studies, the sensitivity and specificity of ultrasound examination of the axillary lymph nodes in diagnosing lymph node involvement are 85% and 78%, respectively. Other sources, however, report a 15.5% of false-negative rate in preoperative ultrasound examinations. Consequently, the diagnostic field of standard radiological methods (ultrasound, CT, MRI) in assessing axillary lymph node status is deemed 'insufficient'. Mammolymphoscintigraphy is an additional diagnostic method based on the detection of pathophysiological alterations in the energy metabolism of tumor cells at the subcellular and molecular levels. Moreover, since metabolic changes usually precede anatomical reorganization, functional imaging methods are regarded as having greater sensitivity in identifying neoplastic changes. Our own experience with radiolabeled 99mTc lipophilic cations in diagnosing axillary lymph node metastasis breast cancer demonstrated that the sensitivity, specificity, and overall accuracy of the method were 80%, 84%, and 76%, respectively. Therefore, in this study, we are incorporating mammolymphoscintigraphy as an essential method for determining lymph node status.

In recent years, the status of axillary lymph nodes has played a diminishing role for adjuvant therapy in early breast cancer patients. Furthermore, in the luminal A subtype of early breast cancer, hormone therapy will be prescribed in the adjuvant setting regardless of axillary lymph node status.

Thus, the existing clinical data do not allow for a definitive conclusion regarding the role of SLNB in early breast cancer patients with the luminal A subtype. To address this and other questions, the present study was initiated

연구 유형

중재적

등록 (추정된)

100

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 러시아 제국
    • Russian Federation
      • Saint Petersburg, Russian Federation, 러시아 제국, 197758
        • 모병
        • N.N. Petrov National Medical Research Center of Oncology

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  1. HER2-negative breast cancer (ER +/ PR +), Ki67 <= 30%, G1-2
  2. age> 59 years.
  3. morphologically confirmed diagnosis of breast cancer, IA-IIA stage
  4. ECOG score 0-2.
  5. the absence of contraindications to surgical intervention (including anesthetic risk is taken into account).
  6. patient is able to provide informed consent and sign approved consent forms to participate in the study.
  7. patients after surgical treatment in the scope of breast resection with sentinel lymph node biopsy (SLNB, group 1) or without axillary surgery (without SLNB, group 2).
  8. N0 status of axillary lymph nodes according to ultrasound and SPECT-CT of the breast with 99mTc-Technetril.

Exclusion Criteria:

  1. Inconsistency with inclusion criteria.
  2. stage T2-4, N1 or M1 cancer
  3. severe uncontrolled concomitant chronic diseases or acute diseases
  4. previous/concurrent malignancy or history of radiation therapy to the chest wall region
  5. any condition that is a contraindication to radiation therapy

5. pregnancy

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Group 2:breast resection without sentinel lymph node biopsy, radiotherapy to the breast area and SLN
  1. Prior to the surgical phase of treatment, all patients undergo SPECT-CT of the breasts with 99mTc-Technetril and SPECT-CT of the sentinel lymph nodes with Tc99m-colloid. A sectoral resection of the breast is performed according to the standard technique, with subsequent histological examination of the excised tissue. Surgical staging using sentinel lymph node biopsy is not performed.
  2. In the next phase, 4-12 weeks after surgery, 3D conformal radiotherapy is administered to the remaining breast tissue, including the region of the sentinel lymph nodes as identified by the preoperative SPECT-CT of the sentinel lymph nodes with Tc99m-colloid. Radiation planning is carried out according to ESTRO protocols, modified in accordance with the atlas of the sentinel lymph nodes.
  3. Based on the postoperative histological findings, adjuvant systemic therapy is prescribed to the patient in accordance with current clinical guidelines.
절차: breast resection
breast resection without sentinel lymph node biopsy, radiotherapy to the breast area and sentinel lymph nodes
활성 비교기: Group 1: Breast resection with biopsy of the sentinel lymph node, radiotherapy
  1. Prior to surgical treatment all patients undergo breast SPECT-CT using 99mTc-Technetril and SPECT-CT of the SLN using Tc99m-colloid. The patient then undergoes a sectoral resection of the breast with a sentinel lymph node biopsy, followed by histological analysis of the excised tissue.
  2. In the next stage, 3D conformal RT is administered to the remaining breast tissue 4 to 12 weeks after the surgical treatment. In patients who have undergone SLNB, only the remaining breast tissue is irradiated, without irradiation of the axillary region, provided that the postoperative histological examination shows no evidence of sentinel lymph node involvement. If metastatic involvement of the SLN is detected, additional RT of the axillary region is performed. Radiation planning is carried out in accordance with ESTRO protocols.
  3. Based on the postoperative histological findings, the patient is prescribed adjuvant systemic therapy in accordance with current clinical guidelines.
절차: Breast resection with sentinel lymph node biopsy
Breast resection with sentinel lymph node biopsy, radiotherapy to the breast and axilla according to current treatment standards

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Axillary recurrence rate.
기간: 2, 3, 5 years
Compare the rate of axillary recurrences in patients with early breast cancer who did not undergo sentinel lymph node biopsy (SLNB) versus those who received standard treatment with SLNB.
2, 3, 5 years

2차 결과 측정

결과 측정
측정값 설명
기간
locoregional recurrence-free survival
기간: 5 and 10 years
Compare locoregional recurrence-free survival in the study groups of patients with early breast cancer
5 and 10 years
overall survival and recurrence-free survival
기간: 5 and 10 years
Compare overall survival and recurrence-free survival in the study groups of patients with early breast cancer
5 and 10 years
frequency and severity of adverse events
기간: 3, 5 and 10 years
Compare the frequency and severity of adverse events, using the current version 5.0 of the CTCAE
3, 5 and 10 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

N.N. Petrov National Medical Research Center of Oncology

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 7월 27일

기본 완료 (추정된)

2027년 5월 25일

연구 완료 (추정된)

2027년 5월 25일

연구 등록 날짜

최초 제출

2026년 5월 6일

QC 기준을 충족하는 최초 제출

2026년 5월 6일

처음 게시됨 (실제)

2026년 5월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 6일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2417313
  • 24/173 (기타 식별자: N.N. Petrov National Medical Research Center of Oncology)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

조기 유방암에 대한 임상 시험

breast resection에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Thailand

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

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