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Fulvestrant (FASLODEX™) as a Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: September 28, 2004
Last updated: June 11, 2008
Last verified: June 2008
The purpose of this study is to evaluate fulvestrant in the preliminary stage of breast cancer treatment and assess the relationship between dose, exposure, degree of reduction in tumor markers, and efficacy in postmenopausal women with estrogen receptor positive disease.

Condition Intervention Phase
Breast Cancer
Drug: Fulvestrant
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Multicenter, Phase II Study Comparing the Effects on Proliferation and the Efficacy and Tolerability of Fulvestrant (FASLODEX®) 500 mg With Fulvestrant (FASLODEX®) 250 mg When Given as Neoadjuvant Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer (T2, 3, 4b, N0-3, M0).

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Anti-proliferative effect after 4 weeks of treatment.

Secondary Outcome Measures:
  • Safety, tolerability, tumor response and pharmacokinetics after 4 weeks of treatment.

Enrollment: 179
Study Start Date: June 2004
Study Completion Date: July 2007
Arms Assigned Interventions
Experimental: 1
250 mg fulvestrant
Drug: Fulvestrant
250 mg & 500 mg intramuscular injection
Other Names:
  • ZD9238
Experimental: 2
500 mg fulvestrant
Drug: Fulvestrant
250 mg & 500 mg intramuscular injection
Other Names:
  • ZD9238


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Postmenopausal women defined as women who have stopped having menstrual periods
  • Written informed consent to participate in the trial
  • Biopsy confirmation of invasive breast cancer
  • Evidence of hormone sensitivity
  • Willingness to undergo biopsies

Exclusion Criteria:

  • Any previous treatment for breast cancer
  • Unwillingness to stop taking any drug known to affect sex hormonal status or a patient in which it would be inappropriate to stop.
  • Any severe concurrent condition that would preclude surgery or that would jeopardize compliance with the study, e.g., uncontrolled cardiac disease or uncontrolled diabetes mellitus
  • The presence of more than one primary tumor
  • History of hypersensitivity to castor oil
  • History of known bleeding disorders
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00093002

  Show 32 Study Locations
Sponsors and Collaborators
Study Director: AstraZeneca Faslodex Medical Science Director, MD AstraZeneca
  More Information

Additional Information: Identifier: NCT00093002     History of Changes
Other Study ID Numbers: 9238IL/0065
Study First Received: September 28, 2004
Last Updated: June 11, 2008

Keywords provided by AstraZeneca:
Early Breast Cancer
neoadjuvant therapy
hormonal treatment
newly diagnosed breast cancer
Estrogen Receptor Positive Breast Cancer
treatment naïve
neoadjuvant treatment
neoadjuvant setting
invasive breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Hormones processed this record on April 28, 2017