ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer
Recruiting
N/A
Interventional Study
Breast Cancer
Chemotherapy
Sentinel Lymph Node
Axillary Lymph Nodes Dissection
Radiotherapy Side Effect
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 820 (estimated)
- Sponsor
- Hospital Universitari de Bellvitge · Other
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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…
Trial Locations
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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.
Excl…
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