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The purpose of this study is to find out if the two different formulations of exemestane (Aromasin), oral and injectable, are equivalent in terms of pharmacodynamics and pharmacokinetics, i.e., if ultimately both formulations have the same efficacy in postmenopausal women with metastatic breast cancer who have failed previous antiestrogens therapy and are equally safe.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exemestane | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the pharmacodynamic equivalence at steady state of the IM formulation of exemestane with the oral formulation in terms of plasma estrone sulphate inhibitory effect in postmenopausal women with advanced breast cancer. |
| Measure | Description | Time Frame |
|---|---|---|
| to characterize the pharmacodynamic profile of the two formulations in terms of estrogens, androgens, and sec hormone binding globulin | ||
| to characterize the pharmacokinetics of exemestane and 17 hydroexemestane after administration of the two formulations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Leicester | United Kingdom |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C056516 | exemestane |
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| to evaluate the relationships between pharmacokinetics and pharmacodynamics after intramuscular and oral administration of exemestane |
| to evaluate the efficacy (as tumor response) |
| to evaluate the incidence and severity of systemic toxicities and of the local tolerability of the injectable formulation |
| to evaluate the effect on serum bone turnover markers |
| D017437 |
| Skin and Connective Tissue Diseases |