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

RecruitingNAAges 18 Years - anyAllHospital Universitari de Bellvitge
NCT04889924 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 r

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📋 Eligibility rules (as published)
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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What it tests

  • Axillary Radiotherapy
  • Lymphadenectomy
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Where

61 sites
GenesisCare Mater
Sydney, Australia
GenesisCare North Shore
Sydney, Australia
GenesisCare Frenchs Forest
Sydney, Australia
GenesisCare Norwest
Sydney, Australia
GenesisCare Hurstville
Sydney, Australia
GenesisCare Campbelltown
Sydney, Australia
Hospital Universitari Germans Trias i Pujol
Badalona, Spain
Instituto Catalán de Oncología de Badalona
Badalona, Spain

…and 53 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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