FASLODEX Clinical Experience & Use Clinical Data: Safety & Tolerability

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

Safety and tolerability

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

FASLODEX side effects: safety and tolerability profile

Most commonly reported adverse events* at a median 15.1-month follow-up:combined North American and European trials1,7

FASLODEX clinical study. Most commonly reported adverse events.

*Regardless of investigator’s assessment of causality.7

Low discontinuation rates

  • Withdrawal rates due to drug-related adverse events: 0.9% with FASLODEX vs 1.2% with ARIMIDEX1

Low risk of estrogenic effects

FASLODEX is an estrogen receptor antagonist with no known agonist effects.7

  • <1% incidence of vaginal bleeding†7
  • <1% incidence of thromboembolic events7
  • †Reported mainly in patients during the first 6 weeks after changing from their existing hormonal treatment to treatment with FASLODEX.7

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

Significantly lower risk of joint disorders (arthritis, arthrosis, and arthralgia):combined North American and European trials2

FASLODEX clinical study. Incidents of joint disorders.
  • Injection site reactions with mild, transient pain and inflammation reported in 7% of patients (1% of treatments) given a single 5 mL injection and 27% of patients (4.6% of treatments) given 2 x 2.5 mL injections of FASLODEX7
  • Because FASLODEX is administered intramuscularly, it should not be used in patients with bleeding diatheses or thrombocytopenia or in patients on anticoagulants7

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.