<clinical_study>
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https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 28, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00040014</url>
</required_header>
<id_info>
<org_study_id>971-ONC-0401-003</org_study_id>
<nct_id>NCT00040014</nct_id>
</id_info>
<brief_title>Open Label, Multicenter, Randomized, Controlled Study of IM or Oral Exemestane (Aromasin) in Postmenopausal Women</brief_title>
<official_title>Open Label, Multicenter, Randomized, Controlled Study of IM or Oral Exemestane (Aromasin) in Postmenopausal Women With Advanced Breast Cancer Having Progressed on Tamoxifen.</official_title>
<sponsors>
<lead_sponsor>
<agency>Pfizer</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Pfizer</source>
<brief_summary>
<textblock>
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.
</textblock>
</brief_summary>
<overall_status>Terminated</overall_status>
<start_date>June 2002</start_date>
<completion_date type="Actual">December 2006</completion_date>
<primary_completion_date type="Actual">December 2006</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>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>
</primary_outcome>
<secondary_outcome>
<measure>to characterize the pharmacodynamic profile of the two formulations in terms of estrogens, androgens, and sec hormone binding globulin</measure>
</secondary_outcome>
<secondary_outcome>
<measure>to characterize the pharmacokinetics of exemestane and 17 hydroexemestane after administration of the two formulations</measure>
</secondary_outcome>
<secondary_outcome>
<measure>to evaluate the relationships between pharmacokinetics and pharmacodynamics after intramuscular and oral administration of exemestane</measure>
</secondary_outcome>
<secondary_outcome>
<measure>to evaluate the efficacy (as tumor response)</measure>
</secondary_outcome>
<secondary_outcome>
<measure>to evaluate the incidence and severity of systemic toxicities and of the local tolerability of the injectable formulation</measure>
</secondary_outcome>
<secondary_outcome>
<measure>to evaluate the effect on serum bone turnover markers</measure>
</secondary_outcome>
<enrollment>100</enrollment>
<condition>Breast Neoplasms</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>exemestane</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- other diagnosed with breast cancer

- estrogen receptor positivity

- Postmenopausal status

- advanced disease

- progression to previous tamoxifen therapy

Exclusion Criteria:

- more than 1 chemotherapy and / or more than 1 hormonotherapy for advanced disease

- previous hormonotherapy other than Tamoxifen
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Pfizer CT.gov Call Center</last_name>
<role>Study Director</role>
<affiliation>Pfizer</affiliation>
</overall_official>
<location>
<facility>
<name>Pfizer Investigational Site</name>
<address>
<city>Leicester</city>
<country>United Kingdom</country>
</address>
</facility>
</location>
<location_countries>
<country>United Kingdom</country>
</location_countries>
<removed_countries>
<country>United States</country>
</removed_countries>
<link>
<url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=971-ONC-0401-003&StudyName=Open+Label%2C+Multicenter%2C+Randomized%2C+Controlled+Study+of+IM+or+Oral+Exemestane+%28Aromasin%29+in+Postmenopausal+Women</url>
<description>To obtain contact information for a study center near you, click here.</description>
</link>
<verification_date>February 2012</verification_date>
<study_first_submitted>June 18, 2002</study_first_submitted>
<study_first_submitted_qc>June 19, 2002</study_first_submitted_qc>
<study_first_posted type="Estimate">June 20, 2002</study_first_posted>
<last_update_submitted>February 14, 2012</last_update_submitted>
<last_update_submitted_qc>February 14, 2012</last_update_submitted_qc>
<last_update_posted type="Estimate">February 16, 2012</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Breast Neoplasms</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Exemestane</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
