ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer
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.
Study details:
A prospective, randomized, open-label, parallel-assigned, multicenter study. The estimated sample size is 820 patients (410 patients in neoadjuvant chemotherapy and 410 in neoadjuvant hormone therapy), over 5 years. Patients will be stratified and analyzed independently according to the neoadjuvant treatment regimen, whether chemotherapy (CT) +/- hormonal therapy (HT).
A pilot phase of the study was carried out with the first 200 patients (Until 1 May 2023), and an interim analysis will also be performed with these first 200 patients.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- NA
Study ID
NCT04889924
Intervention or treatment
RADIATION: Axillary Radiotherapy
PROCEDURE: Lymphadenectomy
Conditions
- Breast Cancer
- Chemotherapy
- Sentinel Lymph Node
- Axillary Lymph Nodes Dissection
- Radiotherapy Side Effect
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Research sites nearby
Closest Location:
GenesisCare Mater
Select from list below to view details:
GenesisCare Mater
Sydney, New South Wales, Australia
GenesisCare North Shore
Sydney, New South Wales, Australia
GenesisCare Frenchs Forest
Sydney, New South Wales, Australia
GenesisCare Norwest
Sydney, New South Wales, Australia
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Who is running the clinical trial?
Hospital Universitari de Bellvitge
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Axillary radiotherapy without lymphadenectomy
| Radiation: Axillary Radiotherapy |
ACTIVE_COMPARATOR: Axillary lymph node dissection
| Procedure: Lymphadenectomy |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | To assess whether the irradiation of the axilla concerning axillary lymph node dissection is not inferior in disease-free survival, in patients with positive sentinel lymph node (SN) after neoadjuvant systemic treatment. | From date of diagnosis until the date of first documented recurrence or death, wichever came first,assessed up to 5 years |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | To assess whether the irradiation of the axilla concerning axillary lymph node dissection is not inferior in overall survival, in patients with positive sentinel lymph node (SN) after neoadjuvant systemic treatment. | From date of diagnosis until the date of death from any cause, assessed up to 5 years |
| Lymphedema Incidence | Volume difference between both arms (cm\^3) above 10% | From date of surgery until the date of first lynphedema apparition, assessed up to 3 years |
References
Clinical Trials Gov: ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast CancerOther trials to consider
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