FASLODEX Clinical Experience & Use Clinical Data: Time to Progression

Two clinical trials evaluated the effectiveness of FASLODEX in comparison with ARIMIDEX® (anastrozole) Tablets in the treatment of postmenopausal women with hormone-responsive locally advanced or metastatic breast cancer who had experienced a first recurrence or progression following antiestrogen therapy.

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Time to progression

In postmenopausal patients with hormone-responsive breast cancer experiencing first recurrence or progression following antiestrogen failure, studies in comparison with ARIMIDEX confirm...

FASLODEX: proven effective, with median time to progression (TTP)* of 5+ months…with a different mechanism of action than an aromatase inhibitor1,3

Median time to progression:combined North American and European trials1

FASLODEX clinical study.  Time to progression.
  • North American trial: median time to progression was 5.5 months with FASLODEX vs 3.4 months with ARIMIDEX1,7
  • European trial: median time to progression was 5.5 months with FASLODEX vs 5.1 months with ARIMIDEX1,7
  • *Time to progression was defined as the time from the date of randomization to the date of objective disease progression or death from any cause.1

Please see Indications and Important Safety Information

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  1. Robertson JF, Osborne CK, Howell A, et al. Fulvestrant versus anastrozole for the treatment of advanced breast carcinoma in postmenopausal women: a prospective combined analysis of two multicenter trials. Cancer. 2003;98(2):229-238.
  2. Howell A, Pippen J, Elledge RM, et al. Fulvestrant versus anastrozole for the treatment of advanced breast carcinoma: a prospectively planned combined survival analysis of two multicenter trials. Cancer. 2005;104(2):236-239.
  3. Wakeling AE. Similarities and distinctions in the mode of action of different classes of antioestrogens. Endocr Relat Cancer. 2000;7(1):17-28.
  4. Data on file, DA-FAS-08. Wilmington, DE: AstraZeneca Pharmaceuticals LP.
  5. Mauriac L, Pippen JE, Albano JQ, Gertler SZ, Osborne CK. Fulvestrant (Faslodex) versus anastrozole for the second-line treatment of advanced breast cancer in subgroups of postmenopausal women with visceral and non-visceral metastases: combined results from two multicentre trials. Eur J Cancer. 2003;39(9):1228-1233.
  6. Data on file, DA-FAS-09. Wilmington, DE: AstraZeneca Pharmaceuticals LP.
  7. Faslodex [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2004.
  8. Pippen J. Similar time to response between fulvestrant and anastrozole: comparison from two phase III trials. Abstract presented at San Antonio Breast Cancer Symposium, December 10, 2005, San Antonio, TX. Abstract 5092.
  9. Dodwell D, Pippen J. Time to response: comparison of fulvestrant and oral endocrine agents. Clin Breast Cancer. 2006;7(3):244-247.
  10. Data on file, DA-FAS-10. Wilmington, DE: AstraZeneca Pharmaceuticals LP.
  11. Data on file, DA-FAS-12. Wilmington, DE: AstraZeneca Pharmaceuticals LP.
  12. FASP6125: Administration of ‘Faslodex’—a monthly intramuscular (i.m.) injection. Macclesfield, Cheshire, UK: AstraZeneca Pharmaceuticals LP; January 2005.
  13. Robertson JF, Nicholson RI, Bundred NJ, Burton G, Osborne CK, Mauriac L; Comparison of the short-term biological effects of 7α-[9-(4,4,5,5,5-pentafluoropentylsylfinyl)-nonyl]estra-1,3,5, (10)-triene-3,17β-diol (Faslodex) versus tamoxifen in postmenopausal women with primary breast cancer. Cancer Res. 2001;61(18):6739-6746.
  14. Vergote I, Robertson JF, Kleeberg U, et al; for the Trial 0020 and 0021 Investigators. Postmenopausal women who progress on fulvestrant (‘Faslodex’) remain sensitive to further endocrine therapy. Breast Cancer Res Treat. 2003;79(2):207-211.