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dc.contributor.authorBergh, Jonas
dc.contributor.authorJönsson, P
dc.contributor.authorLidbrink, E
dc.contributor.authorTrudeau, M
dc.contributor.authorEiermann, W
dc.contributor.authorBrattström, D
dc.contributor.authorLindemann, J
dc.contributor.authorWiklund, F
dc.contributor.authorHenriksson, R
dc.date.accessioned2012-05-09T12:56:31Z
dc.date.available2012-05-09T12:56:31Z
dc.date.issued2012-03-12
dc.identifier.citationFACT: 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, 30(16):1919-25 J Clin Oncolen_GB
dc.identifier.issn1527-7755
dc.identifier.pmid22370325
dc.identifier.doi10.1200/JCO.2011.38.1095
dc.identifier.urihttp://hdl.handle.net/10541/222756
dc.description.abstractPURPOSE 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.
dc.languageENG
dc.language.isoenen
dc.rightsArchived with thanks to Journal of clinical oncology : official journal of the American Society of Clinical Oncologyen_GB
dc.titleFACT: 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.en
dc.typeArticleen
dc.contributor.departmentManchester University and Christie Hospital, Manchester, United Kingdom.en_GB
dc.identifier.journalJournal of Clinical Oncologyen_GB
html.description.abstractPURPOSE 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.


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