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

ConditionsBreast CancerChemotherapySentinel Lymph NodeAxillary Lymph Nodes DissectionRadiotherapy Side Effect
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Universitari de Bellvitge

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Axillary Radiotherapy

    Radiation

    Axillary radiotherapy without lymphadenectomy (level I and II) + level III and supraclavicular +/- internal mammary chain

  • Lymphadenectomy

    Procedure/Surgery

    Axillary lymph node dissection + radiotherapy level III and supraclavicular +/- internal mammary chain

Treatment groups

820 Participants
are divided into 2 treatment groups
Group A: Axillary radiotherapy without lymphadenectomyExperimental treatment 1 intervention
Group B: Axillary lymph node dissectionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Disease-free survival

To 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.

Time frame
From date of diagnosis until the date of first documented recurrence or death, wichever came first,assessed up to 5 years

Secondary outcomes

1

Overall survival

To 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.

Time frame
From date of diagnosis until the date of death from any cause, assessed up to 5 years
2

Lymphedema Incidence

Volume difference between both arms (cm\^3) above 10%

Time frame
From date of surgery until the date of first lynphedema apparition, assessed up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Universitari de Bellvitge

Lead sponsor

Source ClinicalTrials.gov
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