title: Are randomized trials of hormone replacement therapy in symptomatic women with breast cancer feasible?
abstract: OBJECTIVE
  To evaluate the feasibility of conducting a large randomized trial of HRT in symptomatic women with early-stage breast cancer.
  
  
  METHODS
  Open randomized study.
  
  
  METHODS
  Outpatient clinics at The Royal Marsden and St. George's Hospitals, London.
  
  
  METHODS
  One hundred postmenopausal women with early-stage breast cancer, experiencing vasomotor symptoms and/or vaginal dryness.
  
  
  METHODS
  Randomization (1:1) to HRT or no HRT for 6 months.
  
  
  METHODS
  Acceptance, continuance rates, and the reasons eligible women declined study entry.
  
  
  RESULTS
  Acceptance (38.8%) and continuance rates (>80%) were encouraging. The efficacy of HRT did not appear to be antagonized with concomitant tamoxifen. Seventy-five percent of women continued HRT after the study ended. Three women developed metastatic disease. Two used HRT.
  
  
  CONCLUSIONS
  Despite informed consent, a national UK randomized trial of HRT should be feasible and has now been planned. Successful implementation necessitates the provision of information about HRT and the estrogen deficiency side effects of breast cancer therapy to health professionals and women with breast cancer.
authors.affiliation: Department of Surgery, The Royal Marsden Hospital Trust, London, United Kingdom.
authors.forename: J
authors.initials: J
authors.lastname: Marsden
authors.forename: M
authors.initials: M
authors.lastname: Whitehead
authors.forename: R
authors.initials: R
authors.lastname: A'Hern
authors.forename: M
authors.initials: M
authors.lastname: Baum
authors.forename: N
authors.initials: N
authors.lastname: Sacks
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy*; D004958:Estradiol / Q000031:analogs & derivatives / Q000627:therapeutic use; D015914:Estrogen Replacement Therapy; D005260:Female; D006801:Humans; D008875:Middle Aged; D010342:Patient Acceptance of Health Care / Q000706:statistics & numerical data*; D010865:Pilot Projects; D016032:Randomized Controlled Trials as Topic; D011795:Surveys and Questionnaires; D013629:Tamoxifen / Q000627:therapeutic use
chemical_list: D018931:Antineoplastic Agents, Hormonal; D013629:Tamoxifen; D004958:Estradiol