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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.

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    Authors
    Bergh, Jonas
    Jönsson, P
    Lidbrink, E
    Trudeau, M
    Eiermann, W
    Brattström, D
    Lindemann, J
    Wiklund, F
    Henriksson, R
    Affiliation
    Manchester University and Christie Hospital, Manchester, United Kingdom.
    Issue Date
    2012-03-12
    
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    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 (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.
    Citation
    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, 30(16):1919-25 J Clin Oncol
    Journal
    Journal of Clinical Oncology
    URI
    http://hdl.handle.net/10541/222756
    DOI
    10.1200/JCO.2011.38.1095
    PubMed ID
    22370325
    Type
    Article
    Language
    en
    ISSN
    1527-7755
    ae974a485f413a2113503eed53cd6c53
    10.1200/JCO.2011.38.1095
    Scopus Count
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    All Paterson Institute for Cancer Research

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