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

Last updated: March 17, 2025
Sponsor: University Hospital A Coruña
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

Mastectomy

Clinical Study ID

NCT06378294
UHACoruna
  • Ages 18-85
  • Female

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.

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 82
Treatment Group(s): 1
Primary Treatment: Mastectomy
Phase:
Study Start date:
April 20, 2021
Estimated Completion Date:
December 31, 2029

Study 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.

Connect with a study center

  • Hospital Universitario Ferrol

    Ferrol, A Coruña 15402
    Spain

    Site Not Available

  • Hospital Universitario Santiago de Compostela

    Santiago De Compostela, A Coruña 15706
    Spain

    Site Not Available

  • Hospital Universitario Vigo

    Vigo, Pontevedra 36214
    Spain

    Site Not Available

  • Hospital Universitario A Coruña

    A Coruña, 15006
    Spain

    Site Not Available

  • Hospital Universitario Lugo

    Lugo, 27003
    Spain

    Site Not Available

  • Hospital Universitario Ourense

    Orense, 32005
    Spain

    Site Not Available

  • Hospital Universitario Pontevedra

    Pontevedra, 36071
    Spain

    Site Not Available

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