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

March 17, 2025 updated by: Alberto Bouzon, University Hospital A Coruña

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multi-center, prospective study with an estimated sample size of 60 early-stage IBC patients.

Clinically node-negative T1-2 IBC patients undergoing mastectomy with up to 2 macrometases after SLNB will be informed about this study.

Patients will be checked with annual mammography and clinical examination. The axilla will be checked with ultrasound at 3 and 5 years of the surgery.

After surgery, patients will receive axillary radiotherapy, but no ALND, and adjuvant systemic treatment based on international guidelines.

Study Type

Observational

Enrollment (Actual)

82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • A Coruña, Spain, 15006
        • Hospital Universitario A Coruña
      • Lugo, Spain, 27003
        • Hospital Universitario Lugo
      • Orense, Spain, 32005
        • Hospital Universitario Ourense
      • Pontevedra, Spain, 36071
        • Hospital Universitario Pontevedra
    • A Coruña
      • Ferrol, A Coruña, Spain, 15402
        • Hospital Universitario Ferrol
      • Santiago De Compostela, A Coruña, Spain, 15706
        • Hospital Universitario Santiago de Compostela
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36214
        • Hospital Universitario Vigo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Early-stage invasive breast cancer patients receiving upfront mastectomy

Description

Inclusion Criteria:

  • Patients with T1-2 primary invasive breast cancer
  • No suspicion of lymph node involvement prior to sentinel lymph node biopsy
  • Patients undergoing upfront mastectomy
  • Macrometastasis in not more than 2 lymph nodes at sentinel lymph node biopsy
  • Patients treated with adjuvant axillary radiotherapy

Exclusion Criteria:

  • Prior history of invasive breast cancer
  • Medical contraindication for radiotherapy
  • Medical contraindication for adjuvant systemic treatment
  • Planned neoadjuvant systemic treatment
  • Distant metastasis at initial diagnosis
  • Inability to absorb or understand the meaning of the study information

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?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mastectomy patients
clinically node-negative T1-2 invasive breast cancer patients treated with upfront mastectomy
Procedure: Mastectomy
Adjuvant postmastectomy radiotherapy
Other Names:
  • Axillary radiotherapy without axillary lymph node dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: 3 and 5 years
recurrence in the ipsilateral breast/thoracic wall, regional recurrence, distant recurrence or death
3 and 5 years
Axillary recurrence rate
Time Frame: 3 and 5 years
recurrence rate in the ipsilateral axillary lymph nodes
3 and 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
any cause of death as event
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital A Coruña

Collaborators

Complejo Hospitalario Universitario de Vigo
Complejo Hospitalario Universitario de Santiago
Hospital Universitario Lucus Augusti
Complejo Hospitalario Universitario de Pontevedra
Complexo Hospitalario de Ourense
Hospital Arquitecto Marcide

Investigators

  • Principal Investigator: ALBERTO BOUZÓN, Hospital Universitario A Coruña

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2021

Primary Completion (Actual)

December 31, 2024

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

April 18, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 17, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHACoruna

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Results will be published by the investigators in academic journals

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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