Are randomized trials of hormone replacement therapy in symptomatic women with breast cancer feasible?
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.
Marsden
J
J
Department of Surgery, The Royal Marsden Hospital Trust, London, United Kingdom.
Whitehead
M
M
A'Hern
R
R
Baum
M
M
Sacks
N
N
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
D018931:Antineoplastic Agents, Hormonal; D013629:Tamoxifen; D004958:Estradiol