FASLODEX Clinical Experience & Use Clinical Data: Duration of Response

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

Duration of response

In postmenopausal patients with hormone-responsive breast cancer experiencing first recurrence or progression following antiestrogen therapy...

FASLODEX: duration of response

Duration of response in patients who responded:combined North American and European trials11

FASLODEX clinical study. Duration of response data in responding patients.
  • *Number of patients with an objective response.
  • †Total number of patients randomized to FASLODEX in combined trials.
  • Duration of response is based on total number of patients taking FASLODEX (81/428) who responded in the North American and European trials1
  • North American trial: in patients taking FASLODEX who had objective response‡10 (36/206), median duration of response was 11 months (95% CI 6.3-20.5)
  • European trial: in patients taking FASLODEX who had objective response10 (45/222), median duration of response was 9.2 months (95% CI 6.3-11.7)
  • ‡Duration of response is calculated for patients with a complete or partial response as the number of days between the start of objective response and the earliest occurrence of progression or death from any cause.

In postmenopausal patients with hormone-responsive breast cancer experiencing first recurrence or progression following antiestrogen therapy…

Response rates with or without visceral metastases5

Rates of objective response: combined North American and European trials

FASLODEX clinical study information. Objective response rate data.

  • In patients with no visceral metastases (patients presenting with metastases at any location except in the lung and/or liver) the objective response rate was 21.9%5
  • In all patients with visceral metastases (presenting with lung and/or liver metastases, either with or without metastases at other locations), the objective response rate was 15.7%5
  • In patients with visceral metastases only (with lung and/or liver metastases only), the objective response rate was 18.8%5

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.