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Fulvestrant (FASLODEX™) as a Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00093002
First received: September 28, 2004
Last updated: June 11, 2008
Last verified: June 2008
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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 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). |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Breast Cancer
Drug Information available for:
Fulvestrant
U.S. FDA Resources
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:
|
|
Experimental: 2
500 mg fulvestrant
|
Drug: Fulvestrant
250 mg & 500 mg intramuscular injection
Other Names:
|
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| 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
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
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:
| 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 |
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 Antineoplastic Agents, Hormonal Antineoplastic Agents Estrogen Receptor Antagonists Estrogen Antagonists Hormone Antagonists |
ClinicalTrials.gov processed this record on August 18, 2017