Are randomized trials of hormone replacement therapy in symptomatic women with breast cancer feasible?

J Marsden, M Whitehead, R A'Hern, M Baum, N Sacks

Research output: Contribution to journalConference paper

63 Citations (Scopus)


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 WRT 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. (Fertil Steril(R) 2000;73:292-9. (C) 2000 by American Society for Reproductive Medicine).
Original languageEnglish
Pages (from-to)292 - 299
Number of pages8
JournalFertility and Sterility
Issue number2
Publication statusPublished - Feb 2000
EventBritish-Oncological-Association Annual Meeting - ST ANDREWS, SCOTLAND
Duration: 1 Jan 2000 → …


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