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NCT Number: NCT06378294

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–85 year

Sex eligibility

Female

Study type

Observational

Primary location

Hospital Universitario Ferrol, Ferrol, A Coruña, Spain

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mastectomy

Procedure

Adjuvant postmastectomy radiotherapy

Other names: Axillary radiotherapy without axillary lymph node dissection

Primary outcomes

  1. Disease-free survival

    Time frame: 3 and 5 years

    recurrence in the ipsilateral breast/thoracic wall, regional recurrence, distant recurrence or death

  2. Axillary recurrence rate

    Time frame: 3 and 5 years

    recurrence rate in the ipsilateral axillary lymph nodes

Secondary outcomes

  1. Overall survival

    Time frame: 5 years

    any cause of death as event

Sponsors and collaborators

Lead sponsor

University Hospital A Coruña

Other

Collaborators

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

Registry information

Official study title

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

Acronym: MACMA

Important dates

Study start
2021
Primary completion
2024
Study completion
2029
First posted
Apr 22, 2024
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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