title: Phase II clinical trial of high-dose toremifene as primary hormone therapy in aromatase inhibitor-resistant breast cancer.
abstract: BACKGROUND
  Third-generation aromatase inhibitors(AIs)are now common in adjuvant hormone therapy for breast cancer in postmenopausal women. However, a suitable treatment has yet to be established for patients who develop cancer recurrence during or after adjuvant AI therapy.
  
  
  METHODS
  This prospective study evaluated the efficacy and safety of 120mg/day toremifene citrate(TOR-120)administered orally to 23 patients with recurrent breast cancer who were receiving or had received adjuvant AI therapy. Primary therapy for recurrence was TOR-120 monotherapy.
  
  
  RESULTS
  The response rate was 13. 0%(partial response: three patients), the clinical benefit rate was 78. 3%(partial response: three patients; long-term stable disease: 15 patients), and median time to progression was 8. 1 months. Grade 1 adverse events such as loss of appetite, sweating, flushing and edema face were observed.
  
  
  CONCLUSIONS
  TOR-120 monotherapy was effective and safe as a primary hormone therapy for recurrent breast cancer unresponsive to AIs.
authors.affiliation: Dept. of Surgery, Toho University School of Medicine, Japan.
authors.forename: Hideaki
authors.initials: H
authors.lastname: Ogata
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Okamoto
authors.forename: Youichi
authors.initials: Y
authors.lastname: Arima
authors.forename: Hisaki
authors.initials: H
authors.lastname: Fukushima
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Takeyama
authors.forename: Akinori
authors.initials: A
authors.lastname: Yamashita
authors.forename: Masao
authors.initials: M
authors.lastname: Kinoshita
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Suzuki
authors.forename: Terumasa
authors.initials: T
authors.lastname: Sawada
authors.forename: Yoshitomo
authors.initials: Y
authors.lastname: Koshida
authors.forename: Akira
authors.initials: A
authors.lastname: Matsui
authors.forename: Akihiko
authors.initials: A
authors.lastname: Tachibana
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Nakayama
authors.forename: Yoko
authors.initials: Y
authors.lastname: Oishi
authors.forename: Hiroko
authors.initials: H
authors.lastname: Nogi
authors.forename: Ken
authors.initials: K
authors.lastname: Uchida
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D047072:Aromatase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D008875:Middle Aged; D017312:Toremifene / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D018931:Antineoplastic Agents, Hormonal; D047072:Aromatase Inhibitors; D017312:Toremifene