Clinical trial NCT06378294: Locoregional Control With Radiotherapy of Breast Cancer Patients With MACrometastases Treated With MAstectomy (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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: axillary radiotherapy
mastectomy
sentinel lymph node biopsy
Lead sponsor: University Hospital A Coruña
Sponsor class: OTHER
Collaborators: name: Complejo Hospitalario Universitario de Pontevedra
name: Complejo Hospitalario Universitario de Vigo
name: Complejo Hospitalario Universitario de Santiago
name: Hospital Universitario Lucus Augusti
name: Complexo Hospitalario de Ourense
name: Hospital Arquitecto Marcide
First posted: 2024-04-22
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Early-stage invasive breast cancer patients receiving upfront mastectomy

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disease-free survival
timeFrame: 3 and 5 years
measure: Axillary recurrence rate
timeFrame: 3 and 5 years
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Ferrol
country: Spain
facility: Hospital Universitario Ferrol
state: A Coruña
city: Santiago De Compostela
country: Spain
facility: Hospital Universitario Santiago de Compostela
state: A Coruña
city: Vigo
country: Spain
facility: Hospital Universitario Vigo
state: Pontevedra
city: A Coruña
country: Spain
facility: Hospital Universitario A Coruña
city: Lugo
country: Spain
facility: Hospital Universitario Lugo
city: Orense
country: Spain
facility: Hospital Universitario Ourense
city: Pontevedra
country: Spain
facility: Hospital Universitario Pontevedra
Study officials:
affiliation: HOSPITAL UNIVERSITARIO A CORUÑA
name: ALBERTO BOUZÓN
role: PRINCIPAL_INVESTIGATOR
References:
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 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.
citation: 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.