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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00093002
First received: September 28, 2004
Last updated: June 11, 2008
Last verified: June 2008
  Purpose

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
Endpoint Classification: Efficacy Study
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:
  • FASLODEX™
  • ZD9238
Experimental: 2
500 mg fulvestrant
Drug: Fulvestrant
250 mg & 500 mg intramuscular injection
Other Names:
  • FASLODEX™
  • ZD9238

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00093002

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00093002     History of Changes
Other Study ID Numbers: 9238IL/0065, D6997C00003
Study First Received: September 28, 2004
Last Updated: June 11, 2008
Health Authority: United States: Food and Drug Administration

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
Neoplasms
Breast Diseases
Skin Diseases
Estrogens
Estradiol
Fulvestrant
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014