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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00241449 |
The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Nolvadex (tamoxifen) as first-line treatment for postmenopausal women with advanced breast cancer. Patients will be treated until disease progression or until the investigator has determined that treatment is not in the best interest of the patient, whichever occurs first.
Condition | Intervention | Phase |
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Breast Cancer Metastasis |
Drug: Fulvestrant Drug: Tamoxifen |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Double-Blind, Randomized, Multicentre Trial Comparing the Efficacy and Tolerability of 250mg of Faslodex (Long Acting ICI 182,780) With 20mg of Nolvadex (Tamoxifen) in Postmenopausal Women With Advanced Breast Cancer |
Enrollment: | 51 |
Study Start Date: | November 1998 |
Estimated Study Completion Date: | December 2010 |
Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Tamoxifen
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Drug: Tamoxifen
20 mg oral tablet
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2: Experimental
Fulvestrant
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Drug: Fulvestrant
intramuscular injection 250 mg
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Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Postmenopausal women. Written informed consent to participate in the study.
Exclusion Criteria:
Treatment with an investigational or non-approved drug within one month of then start of the study.
Study Director: | AstraZeneca Oncology Medical Science Director, MD | AstraZeneca |
Study ID Numbers: | 9238IL/0025 |
Study First Received: | October 17, 2005 |
Last Updated: | April 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00241449 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Locally advanced breast cancer or metastatic breast cancer |
Estrogen Antagonists Estrogens Skin Diseases Antineoplastic Agents, Hormonal Hormone Antagonists Fulvestrant Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms |
Bone Density Conservation Agents Selective Estrogen Receptor Modulators Tamoxifen Hormones Estrogen Receptor Modulators Neoplasm Metastasis Breast Diseases |
Estrogen Antagonists Skin Diseases Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Fulvestrant Breast Neoplasms Bone Density Conservation Agents Selective Estrogen Receptor Modulators |
Tamoxifen Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes Therapeutic Uses Neoplasm Metastasis Breast Diseases |