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Compares treatment options for Breast Cancer
Official title ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer
ClinicalTrials.gov ID: NCT04889924
What this study is testing
- What it's testing
- 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.
- Time commitment: about 5 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Sydney, New South Wales, Australia
- Badalona, Barcelona, Spain
- Calella, Barcelona, Spain
- Granollers, Barcelona, Spain
- L'Hospitalet de Llobregat, Barcelona, Spain
- Manresa, Barcelona, Spain
- Mataró, Barcelona, Spain
- Sant Cugat del Vallès, 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
+ 18 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sydney, New South Wales, Australia; Badalona, Barcelona, Spain; Calella, Barcelona, Spain; Granollers, Barcelona, Spain; L'Hospitalet de Llobregat, Barcelona, Spain; Manresa, Barcelona, Spain and 32 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.