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. DESIGN Open randomized study. SETTING Outpatient clinics at The Royal Marsden and St. George's Hospitals, London. PATIENT(S) One hundred postmenopausal women with early-stage breast cancer, experiencing vasomotor symptoms and/or vaginal dryness. INTERVENTION(S) Randomization (1:1) to HRT or no HRT for 6 months. MAIN OUTCOME MEASURE(S) Acceptance, continuance rates, and the reasons eligible women declined study entry. RESULT(S) 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. CONCLUSION(S) 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.