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

6 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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

Tipo di studio

Interventistico

Iscrizione (Stimato)

100

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Russia
    • Russian Federation
      • Saint Petersburg, Russian Federation, Russia, 197758
        • Reclutamento
        • N.N. Petrov National Medical Research Center of Oncology

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Procedura: breast resection
breast resection without sentinel lymph node biopsy, radiotherapy to the breast area and sentinel lymph nodes
Comparatore attivo: 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.
Procedura: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Axillary recurrence rate.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
locoregional recurrence-free survival
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

N.N. Petrov National Medical Research Center of Oncology

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

27 luglio 2023

Completamento primario (Stimato)

25 maggio 2027

Completamento dello studio (Stimato)

25 maggio 2027

Date di iscrizione allo studio

Primo inviato

6 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

6 maggio 2026

Primo Inserito (Effettivo)

12 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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