title: Phase III randomized equivalence trial of early breast cancer treatments with or without axillary clearance in post-menopausal patients results after 5 years of follow-up.
abstract: BACKGROUND
  Axillary lymph node clearance (ALNC) improves locoregional control and provides prognostic information for early breast cancer treatment, but effects on survival are controversial. This multicentre, randomized pragmatic equivalence trial compares outcomes for post-menopausal early invasive breast cancer patients after locoregional treatment with ALNC and adjuvant therapies to outcomes after locoregional treatment without ALNC and adjuvant therapies.
  
  
  METHODS
  From 1995-2005, women aged ≥ 50 years with early breast cancer (tumor ≤ 10 mm) and clinically-negative axillary nodes were randomized to receive treatment with ALNC (Ax) or without (no-Ax). Adjuvant therapies were prescribed according to hormonal receptor status and individual histological results. The primary endpoint was overall survival (OS); secondary endpoints were event-free survival (EFS) and functional outcomes. The trial was terminated due to lack of equivalence and low accrual after first interim analyses.
  
  
  BACKGROUND
  NCT00210236.
  
  
  RESULTS
  Of 625 patients, 297 no-Ax and 310 Ax patients were maintained for final per-protocol analyses. OS and EFS at five years were not equivalent (Ax vs. no-Ax: 98% vs. 94% and 96% vs. 90% respectively). Recurrence was higher for no-Ax, particularly in the first five years after surgery. Axillary nodes were positive for 14% Ax patients but only 2% no-Ax patients experienced axillary node recurrence. Functional impairments were greater after ALNC.
  
  
  CONCLUSIONS
  Our results fail to demonstrate equivalence of outcomes when ALNC is omitted from post-menopausal early breast cancer patient treatment. However the low locoregional recurrence rates warrant further examination over a longer duration, in particular to consider whether these would impact on survival.
authors.affiliation: Department of Surgery, Institut Bergonié, 229 cours de l'Argonne, 33076 Bordeaux Cedex, France. avril@bergonie.org
authors.forename: A
authors.initials: A
authors.lastname: Avril
authors.forename: G
authors.initials: G
authors.lastname: Le Bouëdec
authors.forename: G
authors.initials: G
authors.lastname: Lorimier
authors.forename: J M
authors.initials: JM
authors.lastname: Classe
authors.forename: C
authors.initials: C
authors.lastname: Tunon-de-Lara
authors.forename: S
authors.initials: S
authors.lastname: Giard
authors.forename: G
authors.initials: G
authors.lastname: MacGrogan
authors.forename: M
authors.initials: M
authors.lastname: Debled
authors.forename: S
authors.initials: S
authors.lastname: Mathoulin-Pélissier
authors.forename: L
authors.initials: L
authors.lastname: Mauriac
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use; D001365:Axilla; D001943:Breast Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D018270:Carcinoma, Ductal, Breast / Q000401:mortality / Q000473:pathology / Q000556:secondary / Q000628:therapy; D018275:Carcinoma, Lobular / Q000401:mortality / Q000473:pathology / Q000556:secondary / Q000628:therapy; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D057239:Early Termination of Clinical Trials; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008197:Lymph Node Excision / Q000009:adverse effects; D008198:Lymph Nodes / Q000473:pathology; D008207:Lymphatic Metastasis; D015411:Mastectomy, Modified Radical; D015412:Mastectomy, Segmental; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D017698:Postmenopause; D018714:Radiotherapy, Adjuvant; D015996:Survival Rate; D013629:Tamoxifen / Q000627:therapeutic use
chemical_list: D018931:Antineoplastic Agents, Hormonal; D013629:Tamoxifen