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

• ClinicalTrials.gov Identifier: NCT06378294
• Recruitment Status: Recruiting
• First Posted: April 22, 2024
• Last Update Posted: April 25, 2024
• Sponsor: University Hospital A Coruña
• Collaborators: Complejo Hospitalario Universitario de Pontevedra; Complejo Hospitalario Universitario de Vigo; Complejo Hospitalario Universitario de Santiago; Hospital Universitario Lucus Augusti; Complexo Hospitalario de Ourense
• Information provided by (Responsible Party): Alberto Bouzon, University Hospital A Coruña

Tracking Information

• First Submitted Date: April 18, 2024
• First Posted Date: April 22, 2024
• Last Update Posted Date: April 25, 2024
• Actual Study Start Date: April 20, 2021
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 18, 2024)

• Disease-free survival [ Time Frame: 3 and 5 years ]
  recurrence in the ipsilateral breast/thoracic wall, regional recurrence, distant recurrence or death
• Axillary recurrence rate [ Time Frame: 3 and 5 years ]
  recurrence rate in the ipsilateral axillary lymph nodes

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 18, 2024)

Overall survival [ Time Frame: 5 years ]

any cause of death as event

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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 Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 5 Years
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Early-stage invasive breast cancer patients receiving upfront mastectomy
• Condition: Breast Cancer

Intervention

Procedure: Mastectomy

Adjuvant postmastectomy radiotherapy

Other Name: Axillary radiotherapy without axillary lymph node dissection

Study Groups/Cohorts

Mastectomy patients

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

Intervention: Procedure: Mastectomy

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 18, 2024): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2029
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided

Contacts

Contact: ALBERTO BOUZÓN; +34690103810; dr.alberto@aecirujanos.es

Contact: BENIGNO ACEA; +34650482409; benigno.acea.nebril@sergas.es

• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT06378294
• Other Study ID Numbers: UHACoruna
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Results will be published by the investigators in academic journals

• Current Responsible Party: Alberto Bouzon, University Hospital A Coruña
• Original Responsible Party: Alberto Bouzon, University Hospital A Coruña, 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
• Current Study Sponsor: University Hospital A Coruña
• Original Study Sponsor: Same as current

Collaborators

• Complejo Hospitalario Universitario de Pontevedra
• Complejo Hospitalario Universitario de Vigo
• Complejo Hospitalario Universitario de Santiago
• Hospital Universitario Lucus Augusti
• Complexo Hospitalario de Ourense

Investigators

• Principal Investigator: ALBERTO BOUZÓN; HOSPITAL UNIVERSITARIO A CORUÑA

• PRS Account: University Hospital A Coruña
• Verification Date: April 2024