Status:
RECRUITING
ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer
Lead Sponsor:
Hospital Universitari de Bellvitge
Conditions:
Breast Cancer
Chemotherapy
Eligibility:
All Genders
18+ years
Phase:
NA
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), d...
Detailed Description
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)...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
820 Patients enrolled
Trial Details
Trial ID
NCT04889924
Start Date
June 11 2021
End Date
December 31 2028
Last Update
October 2 2025
Active Locations (58)
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1
GenesisCare Mater
Sydney, New South Wales, Australia, 2060
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3
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Sydney, New South Wales, Australia, 2086
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GenesisCare Norwest
Sydney, New South Wales, Australia, 2153