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

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ClinicalTrials.gov Identifier: NCT00093002
Recruitment Status : Completed
First Posted : September 29, 2004
Last Update Posted : June 12, 2008
Sponsor:
Information provided by:
AstraZeneca

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: Fulvestrant Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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).
Study Start Date : June 2004
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
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


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

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

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00093002


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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: AstraZeneca Faslodex Medical Science Director, MD AstraZeneca
More Information
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Additional Information:
Medline Plus - Information on Breast Cancer  This link exits the ClinicalTrials.gov site Breastcancer.org  This link exits the ClinicalTrials.gov site Cancerguide.org - Pros and Cons of Researching Your Cancer  This link exits the ClinicalTrials.gov site Faslodex Information  This link exits the ClinicalTrials.gov site

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ClinicalTrials.gov Identifier: NCT00093002     History of Changes
Other Study ID Numbers: 9238IL/0065
D6997C00003
First Posted: September 29, 2004    Key Record Dates
Last Update Posted: June 12, 2008
Last Verified: June 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:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Estrogens
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists