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

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Procedure: Mastectomy

• Registration Number: NCT06378294
• Lead Sponsor: University Hospital A Coruña

Brief 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.

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 Timeline

• Study Start: 2021-04-20
• Study First Submitted: 2024-04-18
• Study First Submitted QC: 2024-04-18
• Study First Posted: 2024-04-22
• Primary Completion: 2024-12-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 82

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mastectomy patients	Mastectomy	clinically node-negative T1-2 invasive breast cancer patients treated with upfront mastectomy

Primary Outcome Measures

Name	Time	Method
Axillary recurrence rate	3 and 5 years	recurrence rate in the ipsilateral axillary lymph nodes
Disease-free survival	3 and 5 years	recurrence in the ipsilateral breast/thoracic wall, regional recurrence, distant recurrence or death

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 years	any cause of death as event

Trial Locations

Locations (7)

Hospital Universitario Ferrol; 🇪🇸 Ferrol, A Coruña, Spain

Hospital Universitario Santiago de Compostela; 🇪🇸 Santiago De Compostela, A Coruña, Spain

Hospital Universitario Vigo; 🇪🇸 Vigo, Pontevedra, Spain

Hospital Universitario A Coruña; 🇪🇸 A Coruña, Spain

Hospital Universitario Lugo; 🇪🇸 Lugo, Spain

Hospital Universitario Ourense; 🇪🇸 Orense, Spain

Hospital Universitario Pontevedra; 🇪🇸 Pontevedra, Spain