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.

Research output: Contribution to journalArticle

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.

Details

Authors
  • Jonas Bergh
  • Per-Ebbe Jönsson
  • Elisabet Kerstin Lidbrink
  • Maureen Trudeau
  • Wolfgang Eiermann
  • Daniel Brattström
  • Justin P O Lindemann
  • Fredrik Wiklund
  • Roger Henriksson
Organisations
Research areas and keywords

Subject classification (UKÄ) – MANDATORY

  • Cancer and Oncology
Original languageEnglish
Pages (from-to)1919-1925
JournalJournal of Clinical Oncology
Volume30
Issue number16
Publication statusPublished - 2012
Publication categoryResearch
Peer-reviewedYes