Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Internal Mammary Node Irradiation After Neoadjuvant Systemic Therapy for Breast Cancer (IMN-Neo)

3 novembre 2026 aggiornato da: Mahidol University

Internal Mammary Node Irradiation Versus Omission of Internal Mammary Node Irradiation in Breast Cancer Treated With Neoadjuvant Systemic Therapy: A Phase III Multicenter Randomized Trial

This multicenter randomized controlled trial evaluates whether internal mammary node irradiation (IMNI) improves oncologic outcomes in patients with breast cancer who have residual pathologically positive lymph nodes after neoadjuvant systemic therapy.

Eligible participants will be randomly assigned in a 1:1 ratio to receive locoregional radiotherapy either with or without irradiation of the internal mammary lymph nodes. The primary outcome is disease-free survival. Secondary outcomes include overall survival, breast cancer mortality, locoregional recurrence-free survival, distant metastasis-free survival, and treatment-related toxicity, particularly cardiac and pulmonary toxicity.

A total of 1,760 participants are planned to be enrolled across multiple centers in Thailand.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Regional nodal irradiation is an established component of adjuvant radiotherapy for selected patients with node-positive breast cancer. However, the additional benefit of internal mammary node irradiation (IMNI) remains uncertain, particularly in patients receiving contemporary neoadjuvant systemic therapy. Although previous randomized trials have demonstrated potential oncologic benefits of regional nodal irradiation incorporating IMNI, most were conducted in patients undergoing upfront surgery, before the widespread use of modern systemic treatments. Consequently, the benefit-risk balance of IMNI in patients with residual nodal disease after neoadjuvant systemic therapy remains unclear.

IMN-Neo is a phase III, multicenter, randomized, open-label superiority trial designed to evaluate whether the addition of IMNI to standard locoregional radiotherapy improves oncologic outcomes in patients with residual pathologically positive axillary lymph nodes following neoadjuvant systemic therapy.

Participants will be randomized in a 1:1 ratio using computer-generated mixed block randomization, stratified by pathological nodal stage, method of axillary evaluation, primary tumor location, and breast cancer molecular subtype. Randomization will be performed at the time of radiotherapy simulation.

Both treatment groups will receive radiotherapy to the breast or chest wall and regional lymph nodes according to protocol-defined target delineation and dose constraints. The experimental group will additionally receive irradiation of the internal mammary lymph nodes, encompassing the first through third intercostal spaces, whereas the control group will undergo intentional omission of IMNI. Three-dimensional conformal radiotherapy or more advanced techniques will be used, with deep inspiration breath-hold permitted to minimize radiation exposure to surrounding normal tissues.

Participants will undergo scheduled clinical follow-up to assess disease recurrence, survival, and treatment-related adverse effects. Particular attention will be given to cardiac and pulmonary toxicity because of the potential increase in radiation exposure associated with IMNI.

An independent Data and Safety Monitoring Board will oversee participant safety and trial conduct. A prespecified interim efficacy analysis will be performed after approximately 50% of the required primary endpoint events have occurred, with additional monitoring for unexpected oncologic harm and serious treatment-related toxicity.

The trial aims to provide prospective evidence to guide individualized decision-making regarding IMNI in patients with residual nodal disease following contemporary neoadjuvant systemic therapy.

Tipo di studio

Interventistico

Iscrizione (Stimato)

1760

Fase

  • Fase 3

Contatti e Sedi

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

Contatto studio

Luoghi di studio

  • Tailandia
      • Bangkok, Tailandia
        • Chulabhorn Hospital
        • Contatto:
        • Sub-investigatore:
          • Areeya Tinsurawattana, MD
      • Chon Buri, Tailandia
        • Chonburi Cancer Hospital
        • Contatto:
      • Chon Buri, Tailandia
        • Vibharam Amata Nakorn Cancer Hospital
        • Contatto:
      • Lopburi, Tailandia
        • Lop Buri Cancer Hospital
        • Contatto:
      • Nakhon Pathom, Tailandia
        • Synphaet Hospital Nakhon Pathom
        • Contatto:
      • Nakhon Si Thammarat, Tailandia
        • Maharaj Nakhon Si Thammarat Hospital
        • Contatto:
      • Ratchaburi, Tailandia
        • Ratchaburi Hospital
        • Contatto:
      • Samut Sakhon, Tailandia
        • Metropolitan Hospital Tha Chalom, Samut Sakhon Hospital
        • Contatto:
    • Bangkok Noi
      • Bangkok, Bangkok Noi, Tailandia, 10700
        • Siriraj Hospital
        • Contatto:
        • Investigatore principale:
          • Tanun Jitwatcharakomol, MD
        • Sub-investigatore:
          • Pittaya Dankulchai, MD
        • Sub-investigatore:
          • Janjira Petsuksiri, MD
        • Sub-investigatore:
          • Chinnavuth Vatanashevanopakorn, MD
        • Sub-investigatore:
          • Pongpop Tuntapakul, MD
        • Sub-investigatore:
          • Wiwatchai Sittiwong, MD
        • Sub-investigatore:
          • Ratchapas Romrattaphan, MD
        • Sub-investigatore:
          • Krittee Chesdachai, MD

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

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion Criteria:

  • Histologically confirmed breast cancer with pathologically proven lymph node positivity after neoadjuvant systemic therapy.
  • Received neoadjuvant chemotherapy and/or targeted therapy and/or immunotherapy before surgery.
  • Underwent either breast-conserving surgery or mastectomy with lymph node evaluation and is planned to receive adjuvant locoregional radiotherapy.
  • Planned treatment with three-dimensional conformal radiotherapy (3D-CRT) or a more advanced radiotherapy technique.
  • Female ≥ 18 years

Exclusion Criteria:

  • Clinical or radiologic evidence of internal mammary lymph node involvement of any size.
  • Inflammatory breast cancer.
  • Bilateral breast cancer.
  • Multiple primary malignancies, except basal cell carcinoma and premalignant gynecologic lesions including CIN, HSIL, LSIL, VIN, and VAIN.
  • Prior chest irradiation.
  • Disease progression before radiotherapy.
  • Metastatic disease (M1) according to the AJCC 8th edition.

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: IMNI Group

Participants will receive adjuvant locoregional radiotherapy including irradiation of the internal mammary lymph nodes.
Radiazione: Locoregional Radiotherapy With Internal Mammary Node Irradiation

Adjuvant locoregional radiotherapy to the breast or chest wall and regional lymph nodes, including the internal mammary lymph nodes. Allowed dose-fractionation schedules include 50 Gy in 25 fractions, 42.5 Gy in 16 fractions, or 40 Gy in 15 fractions, according to the study protocol.

Altri nomi:
  • IMNI Group
Comparatore attivo: Non-IMNI Group

Participants will receive adjuvant radiotherapy to the breast or chest wall and regional lymph nodes without irradiation of the internal mammary lymph nodes.
Radiazione: Locoregional Radiotherapy Without Internal Mammary Node Irradiation

Adjuvant locoregional radiotherapy to the breast or chest wall and regional lymph nodes, with intentional omission of the internal mammary lymph nodes. Allowed dose-fractionation schedules include 50 Gy in 25 fractions, 42.5 Gy in 16 fractions, or 40 Gy in 15 fractions, according to the study protocol.

Altri nomi:
  • Non-IMNI Group

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Disease-Free Survival (DFS)
Lasso di tempo: From randomization through 5 years

Disease-free survival is defined as the time from randomization to the first occurrence of locoregional recurrence, distant metastasis, or death from any cause, whichever occurs first.
From randomization through 5 years

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival (OS)
Lasso di tempo: Up to 5 years after randomization

Overall survival is defined as the time from randomization to death from any cause.
Up to 5 years after randomization
Breast Cancer Mortality
Lasso di tempo: Up to 5 years after randomization

Breast cancer mortality is defined as the time from randomization to death attributable to breast cancer.
Up to 5 years after randomization
Locoregional Recurrence-Free Survival (LRFS)
Lasso di tempo: Up to 5 years after randomization

Locoregional recurrence-free survival is defined as the time from randomization to the occurrence of locoregional recurrence.
Up to 5 years after randomization
Distant Metastasis-Free Survival (DMFS)
Lasso di tempo: Up to 5 years after randomization

Distant metastasis-free survival is defined as the time from randomization to the occurrence of distant metastasis.
Up to 5 years after randomization
Incidence and Severity of Cardiac Toxicity Assessed Using RTOG/EORTC Radiation Morbidity Scoring Criteria
Lasso di tempo: Last week of radiotherapy, then at 1, 3, and 6 months, and every 6 months through 2 years

Acute cardiac toxicity will be assessed using the RTOG Acute Radiation Morbidity Scoring Criteria, while late cardiac toxicity will be assessed using the RTOG/EORTC Late Radiation Morbidity Scoring Schema. Toxicity will be graded from 0 (no toxicity) to 5 (death related to toxicity). The incidence and severity of cardiac toxicity will be compared between treatment groups.
Last week of radiotherapy, then at 1, 3, and 6 months, and every 6 months through 2 years
Incidence and Severity of Pulmonary Toxicity Assessed Using RTOG/EORTC Radiation Morbidity Scoring Criteria
Lasso di tempo: Last week of radiotherapy, then at 1, 3, and 6 months, and every 6 months through 2 years

Acute pulmonary toxicity will be assessed using the RTOG Acute Radiation Morbidity Scoring Criteria, while late pulmonary toxicity will be assessed using the RTOG/EORTC Late Radiation Morbidity Scoring Schema. Toxicity will be graded from 0 (no toxicity) to 5 (death related to toxicity). The incidence and severity of pulmonary toxicity will be compared between the two treatment groups.
Last week of radiotherapy, then at 1, 3, and 6 months, and every 6 months through 2 years

Collaboratori e investigatori

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

Sponsor

Mahidol University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

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 (Stimato)

1 luglio 2027

Completamento primario (Stimato)

1 luglio 2032

Completamento dello studio (Stimato)

1 luglio 2036

Date di iscrizione allo studio

Primo inviato

28 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 novembre 2026

Primo Inserito (Effettivo)

4 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 novembre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 587/2569(IRB2)

Piano per i dati dei singoli partecipanti (IPD)

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

NO

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 .

Sottoscrivi