title: Adjuvant chemotherapy in older women (ACTION) study - what did we learn from the pilot phase?
abstract: BACKGROUND
  The ACTION trial was initiated to provide evidence from a randomised trial on the effects of chemotherapy in women aged over 70 years where evidence for risk and benefit are lacking.
  
  
  METHODS
  This was a randomised, phase III clinical trial for high risk, oestrogen receptor (ER) negative/ER weakly positive early breast cancer. The trial planned to recruit 1000 women aged 70 years and older, randomised to receive 4 cycles of anthracycline chemotherapy or observation. The primary endpoint was relapse-free interval. The trial included a pilot phase to assess the acceptability and feasibility of recruitment.
  
  
  RESULTS
  The trial opened at 43 UK centres. Information on number of patients approached was available from 38 centres. Of the 43 eligible patients that were approached, 39 were not randomised due to patients declining entry. After 10 months only 4 patients had been randomised and after discussion with the research funder, the trial was closed and funding terminated.
  
  
  CONCLUSIONS
  Despite widespread support at several public meetings, input from patient groups including representation on the Trial Management Group, the trial failed to recruit due to the inability to convince patients to accept randomisation. It would therefore seem that randomising the patients to receive chemotherapy vs observation is not a viable design in the current era for this patient population.
authors: Department of Surgery and Cancer, Imperial College London, London W12 0HS, UK. rleonard@imperial.ac.uk
authors: R
authors: R
authors: Leonard
authors: R
authors: R
authors: Ballinger
authors: D
authors: D
authors: Cameron
authors: P
authors: P
authors: Ellis
authors: L
authors: L
authors: Fallowfield
authors: M
authors: M
authors: Gosney
authors: L
authors: L
authors: Johnson
authors: L S
authors: LS
authors: Kilburn
authors: A
authors: A
authors: Makris
authors: J
authors: J
authors: Mansi
authors: M
authors: M
authors: Reed
authors: A
authors: A
authors: Ring
authors: A
authors: A
authors: Robinson
authors: P
authors: P
authors: Simmonds
authors: G
authors: G
authors: Thomas
authors: J M
authors: JM
authors: Bliss
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy*; D017024:Chemotherapy, Adjuvant; D005260:Female; D006801:Humans; D010349:Patient Compliance; D018579:Patient Selection; D010865:Pilot Projects; D016032:Randomized Controlled Trials as Topic; D012107:Research Design