UK Trial Of Hormone Replacement Therapy (HRT) In Women With A History Of Early Stage Breast Cancer
- Compare disease-free survival and overall survival of postmenopausal women with prior
stage I or II breast cancer treated with hormone replacement therapy (HRT) vs
nonhormonal alternatives to HRT.
- Compare relief of menopausal symptoms and quality of life of patients treated with
- Compare cardiovascular and osteoporotic events in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, age (< 40 years vs ≥ 40 years), and years from diagnosis (≤ 2 vs > 2
to < 5 vs ≥ 5). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral or transdermal HRT comprising estrogen with or without
progesterone for at least 2 years.
- Arm II: Patients are offered advice on nonhormonal HRT alternatives. Menopausal
symptoms are assessed at baseline, at 3, 6, and 12 months, every 6 months for 4 years,
and then annually thereafter. Quality of life is assessed at baseline, at 3, 6, and 12
months, every 6 months for 1 year, and then annually thereafter.
Patients are followed every 6 months for 3 years and then annually thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 2,800-3,000 patients (1,400-1,500 per treatment arm) will be
accrued for this study.
Allocation: Randomized, Primary Purpose: Supportive Care
Jenni Parmar, RN
Institute of Cancer Research, United Kingdom
United States: Federal Government