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

Breast Cancer Clinical Trial

— MACMA  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06378294
• Other study ID #: UHACoruna
• Status: Recruiting
• Start date: April 20, 2021
• Est. completion date: December 31, 2029

Study information

• Verified date: April 2024
• Source: University Hospital A Coruña
• Contact: ALBERTO BOUZÓN
• Phone: +34690103810
• Email: dr.alberto[@]aecirujanos.es
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2024
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Mastectomy
Adjuvant postmastectomy radiotherapy

Locations

Country	Name	City	State
Spain	Hospital Universitario A Coruña	A Coruña
Spain	Hospital Universitario Ferrol	Ferrol	A Coruña
Spain	Hospital Universitario Lugo	Lugo
Spain	Hospital Universitario Ourense	Orense
Spain	Hospital Universitario Pontevedra	Pontevedra
Spain	Hospital Universitario Santiago de Compostela	Santiago De Compostela	A Coruña
Spain	Hospital Universitario Vigo	Vigo	Pontevedra

Sponsors (6)

Lead Sponsor	Collaborator
University Hospital A Coruña	Complejo Hospitalario Universitario de Pontevedra, Complejo Hospitalario Universitario de Santiago, Complejo Hospitalario Universitario de Vigo, Complexo Hospitalario de Ourense, Hospital Universitario Lucus Augusti

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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, — View Citation

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 Wome — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival	recurrence in the ipsilateral breast/thoracic wall, regional recurrence, distant recurrence or death	3 and 5 years
Primary	Axillary recurrence rate	recurrence rate in the ipsilateral axillary lymph nodes	3 and 5 years
Secondary	Overall survival	any cause of death as event	5 years