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

RECRUITINGN/ASponsored by Hospital Universitari de Bellvitge
Actively Recruiting
PhaseN/A
SponsorHospital Universitari de Bellvitge
Started2021-06-11
Est. completion2026-06-30
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions6

Axillary Lymph Nodes DissectionBreast CancerCancerChemotherapyRadiotherapy Side EffectSentinel Lymph Node

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