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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00093002 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study |
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). |
Enrollment: | 179 |
Study Start Date: | June 2004 |
Study Completion Date: | July 2007 |
Arms | Assigned Interventions |
---|---|
1: Experimental
250 mg fulvestrant
|
Drug: Fulvestrant
250 mg & 500 mg intramuscular injection
|
2: Experimental
500 mg fulvestrant
|
Drug: Fulvestrant
250 mg & 500 mg intramuscular injection
|
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | AstraZeneca Faslodex Medical Science Director, MD | AstraZeneca |
Study ID Numbers: | 9238IL/0065, D6997C00003 |
Study First Received: | September 28, 2004 |
Last Updated: | June 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00093002 |
Health Authority: | United States: Food and Drug Administration |
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 |
Skin Diseases Fulvestrant Breast Neoplasms Breast Diseases |
Estrogen Receptor Modulators Estrogen Antagonists Neoplasms Neoplasms by Site Antineoplastic Agents, Hormonal Antineoplastic Agents |
Hormone Antagonists Therapeutic Uses Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Pharmacologic Actions |