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| ID | Type | Description | Link |
|---|---|---|---|
| D6997C00003 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 250 mg fulvestrant |
|
| 2 | Experimental | 500 mg fulvestrant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fulvestrant | Drug | 250 mg & 500 mg intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-proliferative effect after 4 weeks of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety, tolerability, tumor response and pharmacokinetics after 4 weeks of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Faslodex Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Little Rock | Arkansas | United States | |||
| Research Site |
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| Label | URL |
|---|---|
| Medline Plus - Information on Breast Cancer | View source |
| Breastcancer.org | View source |
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| Boston |
| Massachusetts |
| United States |
| Research Site | Winchester | Massachusetts | United States |
| Research Site | Albuquerque | New Mexico | United States |
| Research Site | Hershey | Pennsylvania | United States |
| Research Site | Nashville | Tennessee | United States |
| Research Site | Laredo | Texas | United States |
| Research Site | Innsbruck | Austria |
| Research Site | Salzburg | Austria |
| Research Site | Vienna | Austria |
| Research Site | Barretos | Brazil |
| Research Site | Florianópolis | Brazil |
| Research Site | Goiamia | Brazil |
| Research Site | Porto Alegre | Brazil |
| Research Site | Rio de Janeiro | Brazil |
| Research Site | Santo André | Brazil |
| Research Site | São Paulo | Brazil |
| Research Site | Berlin | Germany |
| Research Site | Hanover | Germany |
| Research Site | Magdeburg | Germany |
| Research Site | München | Germany |
| Research Site | Rostock | Germany |
| Research Site | Bangalore | India |
| Research Site | Hyderabaad | India |
| Research Site | New Delhi | India |
| Research Site | Pune | India |
| Research Site | Trivandrum | India |
| Research Site | Birmingham | United Kingdom |
| Research Site | Bournemouth | United Kingdom |
| Research Site | Dundee | United Kingdom |
| Research Site | Edinburgh | United Kingdom |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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