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FACT: An Open-Label Randomized Phase III Study of Fulvestrant and Anastrozole in Combination Compared With Anastrozole Alone as First-Line Therapy for Patients With Receptor-Positive Postmenopausal Breast Cancer.

Bergh, Jonas; Jönsson, Per-Ebbe LU ; Lidbrink, Elisabet Kerstin; Trudeau, Maureen; Eiermann, Wolfgang; Brattström, Daniel; Lindemann, Justin P O; Wiklund, Fredrik and Henriksson, Roger (2012) In Journal of Clinical Oncology 30(16). p.1919-1925
Abstract
PURPOSE

To compare the effect of therapy with anastrozole versus a combination of fulvestrant and anastrozole in women in first relapse of endocrine-responsive breast cancer.



PATIENTS AND METHODS

Postmenopausal women, or premenopausal women receiving a gonadotropin-releasing hormone agonist, with estrogen receptor- and/or progesterone receptor-positive disease at first relapse after primary treatment of localized disease were open-label randomly assigned to a fulvestrant loading dose (LD) regimen followed by monthly injection plus 1 mg of anastrozole daily or to 1 mg of anastrozole daily alone. The primary end point was time to progression (TTP).



RESULTS:

63 patients... (More)
PURPOSE

To compare the effect of therapy with anastrozole versus a combination of fulvestrant and anastrozole in women in first relapse of endocrine-responsive breast cancer.



PATIENTS AND METHODS

Postmenopausal women, or premenopausal women receiving a gonadotropin-releasing hormone agonist, with estrogen receptor- and/or progesterone receptor-positive disease at first relapse after primary treatment of localized disease were open-label randomly assigned to a fulvestrant loading dose (LD) regimen followed by monthly injection plus 1 mg of anastrozole daily or to 1 mg of anastrozole daily alone. The primary end point was time to progression (TTP).



RESULTS:

63 patients (24.6%) versus 35 patients (13.8%) in the standard arm (P = .0023). Death owing to AEs was reported in 11 (4.3%) and five patients (2.0%) in the experimental versus standard arm, respectively.



CONCLUSION

Fulvestrant (250 mg + LD regimen) in combination with anastrozole offered no clinical efficacy advantage over anastrozole monotherapy in this population of individuals with a relatively high proportion of previous adjuvant antiestrogen exposure. (Less)
Please use this url to cite or link to this publication:
author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Journal of Clinical Oncology
volume
30
issue
16
pages
1919 - 1925
publisher
American Society of Clinical Oncology
external identifiers
  • wos:000304596800011
  • pmid:22370325
  • scopus:84863892191
ISSN
1527-7755
DOI
10.1200/JCO.2011.38.1095
language
English
LU publication?
yes
id
8acce21b-d8ff-4b3e-adb7-6390d0ceaf24 (old id 2432473)
alternative location
http://www.ncbi.nlm.nih.gov/pubmed/22370325?dopt=Abstract
date added to LUP
2012-04-02 11:29:48
date last changed
2017-10-01 04:57:56
@article{8acce21b-d8ff-4b3e-adb7-6390d0ceaf24,
  abstract     = {PURPOSE<br/><br>
To compare the effect of therapy with anastrozole versus a combination of fulvestrant and anastrozole in women in first relapse of endocrine-responsive breast cancer. <br/><br>
<br/><br>
PATIENTS AND METHODS<br/><br>
Postmenopausal women, or premenopausal women receiving a gonadotropin-releasing hormone agonist, with estrogen receptor- and/or progesterone receptor-positive disease at first relapse after primary treatment of localized disease were open-label randomly assigned to a fulvestrant loading dose (LD) regimen followed by monthly injection plus 1 mg of anastrozole daily or to 1 mg of anastrozole daily alone. The primary end point was time to progression (TTP). <br/><br>
<br/><br>
RESULTS: <br/><br>
63 patients (24.6%) versus 35 patients (13.8%) in the standard arm (P = .0023). Death owing to AEs was reported in 11 (4.3%) and five patients (2.0%) in the experimental versus standard arm, respectively. <br/><br>
<br/><br>
CONCLUSION<br/><br>
Fulvestrant (250 mg + LD regimen) in combination with anastrozole offered no clinical efficacy advantage over anastrozole monotherapy in this population of individuals with a relatively high proportion of previous adjuvant antiestrogen exposure.},
  author       = {Bergh, Jonas and Jönsson, Per-Ebbe and Lidbrink, Elisabet Kerstin and Trudeau, Maureen and Eiermann, Wolfgang and Brattström, Daniel and Lindemann, Justin P O and Wiklund, Fredrik and Henriksson, Roger},
  issn         = {1527-7755},
  language     = {eng},
  number       = {16},
  pages        = {1919--1925},
  publisher    = {American Society of Clinical Oncology},
  series       = {Journal of Clinical Oncology},
  title        = {FACT: An Open-Label Randomized Phase III Study of Fulvestrant and Anastrozole in Combination Compared With Anastrozole Alone as First-Line Therapy for Patients With Receptor-Positive Postmenopausal Breast Cancer.},
  url          = {http://dx.doi.org/10.1200/JCO.2011.38.1095},
  volume       = {30},
  year         = {2012},
}