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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04889924




Registration number
NCT04889924
Ethics application status
Date submitted
5/05/2021
Date registered
17/05/2021
Date last updated
13/11/2024

Titles & IDs
Public title
ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer
Scientific title
Axillary Lymph Node Dissection Versus Axillary Radiotherapy in Breast Cancer Patients With Positive Sentinel Node After Neoadjuvant Therapy: A Multicenter Randomized Study
Secondary ID [1] 0 0
PR148/21
Universal Trial Number (UTN)
Trial acronym
ADARNAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Chemotherapy 0 0
Sentinel Lymph Node 0 0
Axillary Lymph Nodes Dissection 0 0
Radiotherapy Side Effect 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Axillary Radiotherapy
Treatment: Surgery - Lymphadenectomy

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

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


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

Treatment: Surgery: Lymphadenectomy
Axillary Lymph node dissection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease-free survival
Timepoint [1] 0 0
From date of diagnosis until the date of first documented recurrence or death, wichever came first,assessed up to 5 years
Secondary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
From date of diagnosis until the date of death from any cause, assessed up to 5 years
Secondary outcome [2] 0 0
Lymphedema Incidence
Timepoint [2] 0 0
From date of surgery until the date of first lynphedema apparition, assessed up to 3 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
1660
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
GenesisCare Mater - Sydney
Recruitment hospital [2] 0 0
GenesisCare North Shore - Sydney
Recruitment hospital [3] 0 0
GenesisCare Frenchs Forest - Sydney
Recruitment hospital [4] 0 0
GenesisCare Norwest - Sydney
Recruitment hospital [5] 0 0
GenesisCare Hurstville - Sydney
Recruitment hospital [6] 0 0
GenesisCare Campbelltown - Sydney
Recruitment postcode(s) [1] 0 0
2060 - Sydney
Recruitment postcode(s) [2] 0 0
2065 - Sydney
Recruitment postcode(s) [3] 0 0
2086 - Sydney
Recruitment postcode(s) [4] 0 0
2153 - Sydney
Recruitment postcode(s) [5] 0 0
2220 - Sydney
Recruitment postcode(s) [6] 0 0
2560 - Sydney
Recruitment outside Australia
Country [1] 0 0
Spain
State/province [1] 0 0
Barcelona
Country [2] 0 0
Spain
State/province [2] 0 0
Bizkaia
Country [3] 0 0
Spain
State/province [3] 0 0
Cádiz
Country [4] 0 0
Spain
State/province [4] 0 0
Gipuzkoa
Country [5] 0 0
Spain
State/province [5] 0 0
Madrid
Country [6] 0 0
Spain
State/province [6] 0 0
Murcia
Country [7] 0 0
Spain
State/province [7] 0 0
Pontevedra
Country [8] 0 0
Spain
State/province [8] 0 0
Santa Cruz De Tenerife
Country [9] 0 0
Spain
State/province [9] 0 0
Tarragona
Country [10] 0 0
Spain
State/province [10] 0 0
A Coruña
Country [11] 0 0
Spain
State/province [11] 0 0
Burgos
Country [12] 0 0
Spain
State/province [12] 0 0
Girona
Country [13] 0 0
Spain
State/province [13] 0 0
Granada
Country [14] 0 0
Spain
State/province [14] 0 0
Málaga
Country [15] 0 0
Spain
State/province [15] 0 0
Pamplona
Country [16] 0 0
Spain
State/province [16] 0 0
Segovia
Country [17] 0 0
Spain
State/province [17] 0 0
Sevilla
Country [18] 0 0
Spain
State/province [18] 0 0
Valencia
Country [19] 0 0
Spain
State/province [19] 0 0
Valladolid
Country [20] 0 0
Spain
State/province [20] 0 0
Álava

Funding & Sponsors
Primary sponsor type
Other
Name
Hospital Universitari de Bellvitge
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT04889924
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Maria Laplana, MDPhD
Address 0 0
Hospital Clínico y Provincial de Barcelona
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amparo Garcia-Tejedor, MDPhD
Address 0 0
Country 0 0
Phone 0 0
34 + 932607695
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04889924