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

RECRUITING

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.

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Study details:

A prospective, randomized, open-label, parallel-assigned, multicenter study. The estimated sample size is 1660 patients, 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. An interim analysis will also be performed with the first 820 patients recruited.

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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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2021-06-01

Primary completion: 2025-06-01

Study completion finish: 2026-12-31

Study type

TREATMENT

Phase

Trial ID

NCT04889924

Intervention or treatment

RADIATION: Axillary Radiotherapy

PROCEDURE: Lymphadenectomy

Conditions

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

Condition: Breast Cancer, Radiotherapy Side Effect and more
RADIATION: Axillary Radiotherapy and other drugs
Sydney, New South Wales, Australia and more
Sponsor: Hospital Universitari de Bellvitge

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

GenesisCare Mater

Research sites nearby

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

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 Axillary radiotherapy (level I and II) + level III and supraclavicular +/- internal mammary chain without lymphadenectomy	RADIATION: Axillary Radiotherapy Axillary radiotherapy without lymphadenectomy (level I and II) + level III and supraclavicular +/- internal mammary chain
ACTIVE_COMPARATOR: Axillary lymph node dissection Axillary lymph node dissection + radiotherapy level III and supraclavicular +/- internal mammary chain	PROCEDURE: Lymphadenectomy Axillary Lymph node dissection

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome 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

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome 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

Frequently Asked Questions

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References

Clinical Trials Gov: ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer