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

NCT06378294 | Active Not Recruiting

• 1 other identifier: UHACoruna
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 7

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.

Conditions

Breast Cancer

Keywords

axillary radiotherapy; mastectomy; sentinel lymph node biopsy

Outcome Measures

Primary Outcomes (2)

• Disease-free survival

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

  3 and 5 years

• Axillary recurrence rate

  recurrence rate in the ipsilateral axillary lymph nodes

  3 and 5 years

Secondary Outcomes (1)

• Overall survival

  5 years

Study Arms (1)

Mastectomy patients

clinically node-negative T1-2 invasive breast cancer patients treated with upfront mastectomy

Procedure: Mastectomy

Interventions

Mastectomy PROCEDURE

Adjuvant postmastectomy radiotherapy

Also known as: Axillary radiotherapy without axillary lymph node dissection

Mastectomy patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Early-stage invasive breast cancer patients receiving upfront mastectomy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital A Coruña: lead
• Complejo Hospitalario Universitario de Pontevedra: collaborator
• Complejo Hospitalario Universitario de Vigo: collaborator
• Complejo Hospitalario Universitario de Santiago: collaborator
• Hospital Universitario Lucus Augusti: collaborator
• Complexo Hospitalario de Ourense: collaborator
• Hospital Arquitecto Marcide: collaborator

Study Sites (7)

Hospital Universitario Ferrol

Ferrol, A Coruña, 15402, Spain

Location

Hospital Universitario Santiago de Compostela

Santiago de Compostela, A Coruña, 15706, Spain

Location

Hospital Universitario Vigo

Vigo, Pontevedra, 36214, Spain

Location

Hospital Universitario A Coruña

A Coruña, 15006, Spain

Location

Hospital Universitario Lugo

Lugo, 27003, Spain

Location

Hospital Universitario Ourense

Ourense, 32005, Spain

Location

Hospital Universitario Pontevedra

Pontevedra, 36071, Spain

Location

Related Publications (2)

• Giuliano AE, Ballman KV, McCall L, Beitsch PD, Brennan MB, Kelemen PR, Ollila DW, Hansen NM, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, Hunt KK, Morrow M. Effect of Axillary Dissection vs No Axillary Dissection on 10-Year Overall Survival Among Women With Invasive Breast Cancer and Sentinel Node Metastasis: The ACOSOG Z0011 (Alliance) Randomized Clinical Trial. JAMA. 2017 Sep 12;318(10):918-926. doi: 10.1001/jama.2017.11470.

  PMID: 28898379 RESULT

• Bartels SAL, Donker M, Poncet C, Sauve N, Straver ME, van de Velde CJH, Mansel RE, Blanken C, Orzalesi L, Klinkenbijl JHG, van der Mijle HCJ, Nieuwenhuijzen GAP, Veltkamp SC, van Dalen T, Marinelli A, Rijna H, Snoj M, Bundred NJ, Merkus JWS, Belkacemi Y, Petignat P, Schinagl DAX, Coens C, van Tienhoven G, van Duijnhoven F, Rutgers EJT. Radiotherapy or Surgery of the Axilla After a Positive Sentinel Node in Breast Cancer: 10-Year Results of the Randomized Controlled EORTC 10981-22023 AMAROS Trial. J Clin Oncol. 2023 Apr 20;41(12):2159-2165. doi: 10.1200/JCO.22.01565. Epub 2022 Nov 16.

  PMID: 36383926 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• ALBERTO BOUZÓN

  HOSPITAL UNIVERSITARIO A CORUÑA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, M.D., Ph.D.

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 22, 2024
• Study Start: April 20, 2021
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (7)