- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00093002
Fulvestrant (FASLODEX™) as a Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer
June 11, 2008 updated by: AstraZeneca
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).
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
179
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Innsbruck, Austria
- Research Site
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Salzburg, Austria
- Research Site
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Vienna, Austria
- Research Site
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Wien, Austria
- Research Site
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Barretos, Brazil
- Research Site
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Florianopolis, Brazil
- Research Site
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Goiamia, Brazil
- Research Site
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Porto Alegre, Brazil
- Research Site
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Rio de Janeiro, Brazil
- Research Site
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Santo Andre, Brazil
- Research Site
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Sao Paulo, Brazil
- Research Site
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Berlin, Germany
- Research Site
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Hannover, Germany
- Research Site
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Magdeburg, Germany
- Research Site
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Munchen, Germany
- Research Site
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Rostock, Germany
- Research Site
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Bangalore, India
- Research Site
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Hyderabaad, India
- Research Site
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New Delhi, India
- Research Site
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Pune, India
- Research Site
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Trivandrum, India
- Research Site
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Birmingham, United Kingdom
- Research Site
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Bournemouth, United Kingdom
- Research Site
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Dundee, United Kingdom
- Research Site
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Edinburgh, United Kingdom
- Research Site
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Arkansas
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Little Rock, Arkansas, United States
- Research Site
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Massachusetts
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Boston, Massachusetts, United States
- Research Site
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Winchester, Massachusetts, United States
- Research Site
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New Mexico
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Albuquerque, New Mexico, United States
- Research Site
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Pennsylvania
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Hershey, Pennsylvania, United States
- Research Site
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Tennessee
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Nashville, Tennessee, United States
- Research Site
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Texas
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Laredo, Texas, United States
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
250 mg fulvestrant
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250 mg & 500 mg intramuscular injection
Other Names:
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Experimental: 2
500 mg fulvestrant
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250 mg & 500 mg intramuscular injection
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Anti-proliferative effect after 4 weeks of treatment.
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Secondary Outcome Measures
Outcome Measure |
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Safety, tolerability, tumor response and pharmacokinetics after 4 weeks of treatment.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2004
Study Completion (Actual)
July 1, 2007
Study Registration Dates
First Submitted
September 28, 2004
First Submitted That Met QC Criteria
September 28, 2004
First Posted (Estimate)
September 29, 2004
Study Record Updates
Last Update Posted (Estimate)
June 12, 2008
Last Update Submitted That Met QC Criteria
June 11, 2008
Last Verified
June 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9238IL/0065
- D6997C00003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
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Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
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University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
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Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
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CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
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University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
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University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
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Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
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Baylor Breast Care CenterRecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer InvasiveUnited States
Clinical Trials on Fulvestrant
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Genor Biopharma Co., Ltd.RecruitingLocally Advanced or Metastatic Breast CancerChina
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Ontario Clinical Oncology Group (OCOG)AstraZenecaCompleted
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Xuanzhu Biopharmaceutical Co., Ltd.RecruitingAdvanced Breast CancerChina
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Jiangsu Hansoh Pharmaceutical Co., Ltd.Recruiting
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Ahon Pharmaceutical Co., Ltd.RecruitingAdvanced Breast Cancer | Female Breast CancerChina
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Roswell Park Cancer InstituteCompleted
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Fudan UniversityActive, not recruiting
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Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Completed
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Sun Yat-sen UniversityAstraZenecaUnknown
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Zhejiang Cancer HospitalRecruitingBreast Neoplasm FemaleChina