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

NCT04889924

RecruitingNA

Sponsor: Hospital Universitari de Bellvitge

Conditions: Breast Cancer, Chemotherapy, Sentinel Lymph Node, Axillary Lymph Nodes Dissection, Radiotherapy Side Effect

Interventions: Axillary Radiotherapy, Lymphadenectomy

Countries: Australia, Spain

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (60)
  • Sydney, New South Wales, Australia
  • Sydney, New South Wales, Australia
  • Sydney, New South Wales, Australia
  • Sydney, New South Wales, Australia
  • Sydney, New South Wales, Australia
  • Sydney, New South Wales, Australia
  • Badalona, Barcelona, Spain
  • Badalona, Barcelona, Spain
  • Calella, Barcelona, Spain
  • Granollers, Barcelona, Spain
  • L'Hospitalet de Llobregat, Barcelona, Spain
  • L'Hospitalet de Llobregat, Barcelona, Spain
  • L'Hospitalet de Llobregat, Barcelona, Spain
  • Manresa, Barcelona, Spain
  • Mataró, Barcelona, Spain
  • Sant Cugat del Vallès, Barcelona, Spain
  • Terrassa, Barcelona, Spain
  • Terrassa, Barcelona, Spain
  • Viladecans, Barcelona, Spain
  • Barakaldo, Bizkaia, Spain
  • Galdakao, Bizkaia, Spain
  • Cadiz, Cádiz, Spain
  • Donostia / San Sebastian, Gipuzkoa, Spain
  • Alcalá de Henares, Madrid, Spain
  • Leganés, Madrid, Spain
  • Majadahonda, Madrid, Spain
  • Parla, Madrid, Spain
  • El Palmar, Murcia, Spain
  • Vigo, Pontevedra, Spain
  • Vigo, Pontevedra, Spain
  • + 30 more on CT.gov