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ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer

RECRUITING

In the case of primary surgery, in patients with sentinel node involvement, it has already been shown that omitting axillary lymph node dissection (ALND), often combining axillary radiotherapy (RT), does not worsen the prognosis and does significantly reduce the appearance of lymphedema. However, patients who have received neoadjuvant systemic treatment cannot benefit from this option, even though in the majority of those who have responded well to treatment, a residual disease in the armpit is low, but there are no studies yet published that supports the possibility of not performing lymphadenectomy. The primary endpoint is to evaluate wether axillary radiotherapy (ART) presents a lower risk of lymphedema with respect to lymphadenectomy (ALND) in patients with breast cancer who, after neoadjuvant systemic treatment (NST), present the sentinel node affected.

Likewise, we will evaluate recurrences and overall survival in both groups. Finally, we will analyze the quality of life of these patients.

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Study details:

A prospective, randomized, open-label, parallel-assigned, multicenter study. The estimated sample size is 1660 patients, over 5 years. Patients will be stratified and analyzed independently according to the neoadjuvant treatment regimen, whether chemotherapy (CT) +/- hormonal therapy (HT).

A pilot phase of the study was carried out with the first 200 patients. An interim analysis will also be performed with the first 820 patients recruited.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • T1-T4 N0/ T0-T4 N1 at diagnosis and subsidiary of neoadjuvant treatment
  • Post-CT SLN with ≤2 macrometastasis/micrometastasis or ITCs
  • Post-CT axillary response by ultrasound or MRI
  • Complete at least 70% of neoadjuvant chemotherapy and 6 months of endocrine treatment.
  • Exclusion criteria

  • cN2
  • ypN0
  • History of breast surgery for ipsilateral cancer in the last 10 years
  • History of other cancer in the last 5 years, except squamous carcinoma of the skin.
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2021-06-01

    Primary completion: 2025-06-01

    Study completion finish: 2026-12-31

    study type

    Study type

    TREATMENT

    phase

    Phase

      NA

    trial

    Trial ID

    NCT04889924

    Intervention or treatment

    RADIATION: Axillary Radiotherapy

    PROCEDURE: Lymphadenectomy

    Conditions

    • Breast Cancer
    • Radiotherapy Side Effect
    • Chemotherapy
    • Sentinel Lymph Node
    • Axillary Lymph Nodes Dissection
    Image related to Breast Cancer
    • Condition: Breast Cancer, Radiotherapy Side Effect and more

    • RADIATION: Axillary Radiotherapy and other drugs

    • Sydney, New South Wales, Australia and more

    • Sponsor: Hospital Universitari de Bellvitge

    Find a site

    Closest Location:

    GenesisCare Mater

    Research sites nearby

    Select from list below to view details:

    • GenesisCare Mater

      Sydney, New South Wales, Australia

    • GenesisCare North Shore

      Sydney, New South Wales, Australia

    • GenesisCare Frenchs Forest

      Sydney, New South Wales, Australia

    • GenesisCare Norwest

      Sydney, New South Wales, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: Axillary radiotherapy without lymphadenectomy
    • Axillary radiotherapy (level I and II) + level III and supraclavicular +/- internal mammary chain without lymphadenectomy
    RADIATION: Axillary Radiotherapy
    • Axillary radiotherapy without lymphadenectomy (level I and II) + level III and supraclavicular +/- internal mammary chain
    ACTIVE_COMPARATOR: Axillary lymph node dissection
    • Axillary lymph node dissection + radiotherapy level III and supraclavicular +/- internal mammary chain
    PROCEDURE: Lymphadenectomy
    • Axillary Lymph node dissection

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Disease-free survivalTo assess whether the irradiation of the axilla concerning axillary lymph node dissection is not inferior in disease-free survival, in patients with positive sentinel lymph node (SN) after neoadjuvant systemic treatment.From date of diagnosis until the date of first documented recurrence or death, wichever came first,assessed up to 5 years

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Overall survivalTo assess whether the irradiation of the axilla concerning axillary lymph node dissection is not inferior in overall survival, in patients with positive sentinel lymph node (SN) after neoadjuvant systemic treatment.From date of diagnosis until the date of death from any cause, assessed up to 5 years
    Lymphedema IncidenceVolume difference between both arms (cm\^3) above 10%From date of surgery until the date of first lynphedema apparition, assessed up to 3 years

    Frequently Asked Questions

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    References

    Clinical Trials Gov: ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer

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