HABITS (hormonal replacement therapy after breast cancer—is it safe?), a randomised comparison: trial stopped

doi:10.1016/S0140-6736(04)15493-7

The Lancet

Volume 363, Issue 9407, 7 February 2004, Pages 453-455

https://doi.org/10.1016/S0140-6736(04)15493-7 Get rights and content

Summary

In the 1990s, two randomised clinical trials started in Scandinavia addressing whether hormone replacement therapy (HRT) is safe for women with previous breast cancer. We report the findings of the safety analysis in HABITS (hormonal replacement therapy after breast cancer—is it safe?), an open randomised clinical trial with allocation to either HRT or best treatment without hormones. The main endpoint was any new breast cancer event. All analyses were done according to intention-to-treat. Until September, 2003, 434 women were randomised; 345 had at least one follow-up report. After a median follow-up of 2·1 years, 26 women in the HRT group and seven in the non-HRT group had a new breast-cancer event. All women with an event in the HRT group and two of those in the non-HRT group were exposed to HRT and most women had their event when on treatment. We decided that these findings indicated an unacceptable risk for women exposed to HRT in the HABITS trial, and the trial was terminated on Dec 17, 2003.

Published online Feb 3, 2004. http://image.thelancet.com/extras/03let12260web.pdf

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Fast track — Research LettersHABITS (hormonal replacement therapy after breast cancer—is it safe?), a randomised comparison: trial stopped

Summary

Hormone replacement therapy after breast cancer: a systematic review and quantitative assessment of risk

J Clin Oncol

Hormone replacement therapy after a diagnosis of breast cancer in relation to recurrence and mortality

J Natl Cancer Inst

Breast cancer and hormone replacement therapy: collaborative reanalysis of data from 51 epidemiological studies of 52 705 women with breast cancer and 108 411 women without breast cancer

Lancet

Fast track — Research Letters
HABITS (hormonal replacement therapy after breast cancer—is it safe?), a randomised comparison: trial stopped