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

Holmberg, L and Anderson, Harald LU (2004) In The Lancet 363(9407). p.453-455
Abstract
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... (More)
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. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
The Lancet
volume
363
issue
9407
pages
453 - 455
publisher
Elsevier Limited
external identifiers
  • wos:000188999500013
  • pmid:14962527
  • scopus:1142285536
ISSN
1474-547X
DOI
10.1016/S0140-6736(04)15493-7
language
English
LU publication?
yes
id
38acf379-7e90-4a35-a5e9-185ac776bc4a (old id 288242)
date added to LUP
2007-10-26 16:12:18
date last changed
2017-12-10 03:45:40
@article{38acf379-7e90-4a35-a5e9-185ac776bc4a,
  abstract     = {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.},
  author       = {Holmberg, L and Anderson, Harald},
  issn         = {1474-547X},
  language     = {eng},
  number       = {9407},
  pages        = {453--455},
  publisher    = {Elsevier Limited},
  series       = {The Lancet},
  title        = {HABITS (hormonal replacement therapy after breast cancer - is it safe?), a randomised comparison: trial stopped},
  url          = {http://dx.doi.org/10.1016/S0140-6736(04)15493-7},
  volume       = {363},
  year         = {2004},
}