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

NCT06378294 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 82

Last updated 2025-03-20

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Mastectomy

Adjuvant postmastectomy radiotherapy

Sponsors & Collaborators

  • Complejo Hospitalario Universitario de Pontevedra

    collaborator OTHER

  • Complejo Hospitalario Universitario de Vigo

    collaborator OTHER

  • Complejo Hospitalario Universitario de Santiago

    collaborator OTHER

  • Hospital Universitario Lucus Augusti

    collaborator OTHER

  • Complexo Hospitalario de Ourense

    collaborator OTHER

  • Hospital Arquitecto Marcide

    collaborator OTHER

  • University Hospital A Coruña

    lead OTHER

Principal Investigators

  • ALBERTO BOUZÓN · HOSPITAL UNIVERSITARIO A CORUÑA

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-20
Primary Completion
2024-12-31
Completion
2029-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06378294 on ClinicalTrials.gov