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NCT06378294Recruiting

Locoregional Control With Radiotherapy of Breast Cancer Patients With MACrometastases Treated With MAstectomy (MACMA)

Locoregional Control With Radiotherapy of cT1-2N0 Invasive Breast Cancer Patients With MACrometastases in the Sentinel Node Treated With MAstectomy: a Multi-center Observational Study
University Hospital A CoruñaClinicalTrials.govprocedure
Verified
Study focus
Disease/Condition
Breast Cancer
Drug/Device/Intervention
Mastectomy
Study type
Observational
Intervention type
procedure
Sponsor & location
Primary sponsor
University Hospital A Coruña
Location
Ferrol,Santiago De Compostela,Vigo,A Coruña,Lugo,Orense,Pontevedra, Spain
Timeline & enrollment
Phase
N/A
Start date
Apr 20, 2021
End date
Dec 31, 2029
Enrollment
60 participants
Primary outcome

Disease-free survival,Axillary recurrence rate

Summary

Sentinel lymph node biopsy (SLNB) is the standard procedure to stage the axilla in clinically
 node-negative invasive breast cancer (IBC) patients undergoing upfront surgery.
 
 The ACOSOG-Z0011 and the AMAROS trial demonstrated that SLNB with or without radiotherapy
 provided equivalent local control and survival to axillary lymph node dissection (ALND) in
 early-stage breast cancer patients with 1 or 2 positive SLNs. However, the ACOSOG-Z0011 trial
 did not included patients treated with mastectomy, and the AMAROS trial only included 17% of
 mastectomy patients.
 
 The investigators conduct an observational cohort study of early stage breast cancer patients
 receiving upfront mastectomy with 1 or 2 macrometastases after SLNB. The study aim to
 demonstrate a 5-year disease-free survival of not less than 80% when ALND is omitted and
 replaced by axillary radiotherapy, and determine the axillary recurrence rate.

ICD-10 classifications
Malignant neoplasm of breastMalignant neoplasm of breastCarcinoma in situ of breast, unspecifiedMalignant neoplasm: Breast, unspecifiedOther carcinoma in situ of breast
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06378294
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06378294 through Pure Global AI's free database. This phase not specified trial is sponsored by University Hospital A Coruña and is currently Recruiting. The study focuses on Breast Cancer. Target enrollment is 60 participants.

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