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.
RCT Entities:
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.
Authors: Richard J Santen; D Craig Allred; Stacy P Ardoin; David F Archer; Norman Boyd; Glenn D Braunstein; Henry G Burger; Graham A Colditz; Susan R Davis; Marco Gambacciani; Barbara A Gower; Victor W Henderson; Wael N Jarjour; Richard H Karas; Michael Kleerekoper; Roger A Lobo; JoAnn E Manson; Jo Marsden; Kathryn A Martin; Lisa Martin; JoAnn V Pinkerton; David R Rubinow; Helena Teede; Diane M Thiboutot; Wulf H Utian Journal: J Clin Endocrinol Metab Date: 2010-06-21 Impact factor: 5.958
Authors: Francesca Poggio; Lucia Del Mastro; Marco Bruzzone; Marcello Ceppi; Maria Grazia Razeti; Piero Fregatti; Tommaso Ruelle; Paolo Pronzato; Claudia Massarotti; Maria Alice Franzoi; Matteo Lambertini; Marco Tagliamento Journal: Breast Cancer Res Treat Date: 2021-11-03 Impact factor: 4.872