RecruitingNot ApplicableNCT04889924

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

Axillary Lymph Node Dissection Versus Axillary Radiotherapy in Breast Cancer Patients With Positive Sentinel Node After Neoadjuvant Therapy: A Multicenter Randomized Study

Sponsor

Hospital Universitari de Bellvitge

Enrollment

820 participants

Start Date

Jun 11, 2021

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two approaches to managing the lymph nodes under the arm in breast cancer patients who had a positive sentinel node (the first lymph node where cancer can spread) after completing chemotherapy before surgery. One approach is full lymph node removal; the other is radiation therapy to the armpit area. **You may be eligible if...** - You had breast cancer (T1–T4 or N1 at diagnosis) and received chemotherapy before surgery - After chemotherapy, your sentinel node biopsy showed 1 or 2 affected lymph nodes (small deposits or micrometastases) or only isolated tumor cells - Imaging showed your armpit responded to chemotherapy - You completed at least 70% of your chemotherapy and 6 months of hormone therapy **You may NOT be eligible if...** - You had clinically advanced armpit disease (N2) at diagnosis - Your sentinel node came back clean after chemotherapy (ypN0) - You had breast surgery for cancer on the same side in the past 10 years - You have had another cancer in the past 5 years (except skin cancer) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONAxillary Radiotherapy

Axillary radiotherapy without lymphadenectomy (level I and II) + level III and supraclavicular +/- internal mammary chain

PROCEDURELymphadenectomy

Axillary lymph node dissection + radiotherapy level III and supraclavicular +/- internal mammary chain