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.
(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:
https://lup.lub.lu.se/record/2432473
- author
- Bergh, Jonas ; Jönsson, Per-Ebbe LU ; Lidbrink, Elisabet Kerstin ; Trudeau, Maureen ; Eiermann, Wolfgang ; Brattström, Daniel ; Lindemann, Justin P O ; Wiklund, Fredrik and Henriksson, Roger
- organization
- publishing date
- 2012
- 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
- pmid:22370325
- 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
- 2016-04-04 08:18:37
- date last changed
- 2022-04-15 20:08:36
@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}},
doi = {{10.1200/JCO.2011.38.1095}},
volume = {{30}},
year = {{2012}},
}