Faslodex Clinical Experience & Use Clinical Data: Trials Overview

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.

Click on any link below to read clinical study data on a specific topic.

Trials Overview

Objective Response Rates

Time to Objective Response

Duration of Response

Time to Progression

Overall Survival

Safety & Tolerability

Clinical data: trials overview

Two multicenter clinical trials, one conducted in North America and the other predominantly in Europe, evaluated the efficacy and tolerability of FASLODEX in comparison with ARIMIDEX in the treatment of postmenopausal women with locally advanced or metastatic breast cancer. All patients in the study had received previous antiestrogen therapy.1,14

Patient types in locally advanced or metastatic breast cancer clinical trials of FASLODEX

  • ~45% of patients studied had recurrence while on adjuvant antiestrogen therapy or within 12 months of therapy completion6
  • ~55% of patients studied had progression on antiestrogen therapy as their first hormonal treatment for advanced disease6
FASLODEX clinical study information.

*While on adjuvant antiestrogen therapy or within 12 months of completion.1,6

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.