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Clinical Trials in Spain / NCT06378294
Active, not recruiting Observational

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

NCT06378294 · tracked via the Priya Life Science Spain tracker
Sponsor
University Hospital A Coruña
Phase
Observational
Started
2021-04-20
Last updated
2025-03-20

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Mastectomy

Mastectomy: Adjuvant postmastectomy radiotherapy

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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 outcome measure(s)

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

Trial sites (7)

FacilityCityRegionStatus
Hospital Universitario Ferrol Ferrol A Coruña
Hospital Universitario Santiago de Compostela Santiago de Compostela A Coruña
Hospital Universitario Vigo Vigo Pontevedra
Hospital Universitario A Coruña A Coruña Spain
Hospital Universitario Lugo Lugo Spain
Hospital Universitario Ourense Ourense Spain
Hospital Universitario Pontevedra Pontevedra Spain

More University Hospital A Coruña trials in Spain

The PreQ-20 TRIAL, a Prospective Cohort Study of Patients Undergoing Prepectoral Breast Reconstruction Active, not recruiting

Other trials for the same condition

A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer Recruiting
A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor. Active, not recruiting
Selective Sentinella Lymph Node Biopsy with Indocyanine Green in Patients with Breast Cancer Recruiting
ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions Recruiting
Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06378294 on ClinicalTrials.gov ↗ ← All trials in Spain