Back to resultsOpen Label, Multicenter, Randomized, Controlled Study of IM or Oral Exemestane (Aromasin) in Postmenopausal Women
Primary Purpose
Breast Neoplasms
Status
Terminated
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
exemestane
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms
Eligibility Criteria
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
Sites / Locations
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00040014
Brief Title
Open Label, Multicenter, Randomized, Controlled Study of IM or Oral Exemestane (Aromasin) in Postmenopausal Women
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Terminated
Study Start Date
June 2002 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
exemestane
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
to characterize the pharmacodynamic profile of the two formulations in terms of estrogens, androgens, and sec hormone binding globulin
Title
to characterize the pharmacokinetics of exemestane and 17 hydroexemestane after administration of the two formulations
Title
to evaluate the relationships between pharmacokinetics and pharmacodynamics after intramuscular and oral administration of exemestane
Title
to evaluate the efficacy (as tumor response)
Title
to evaluate the incidence and severity of systemic toxicities and of the local tolerability of the injectable formulation
Title
to evaluate the effect on serum bone turnover markers
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Leicester
Country
United Kingdom
12. IPD Sharing Statement
Links:
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
Description
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Learn more about this trial
Open Label, Multicenter, Randomized, Controlled Study of IM or Oral Exemestane (Aromasin) in Postmenopausal Women
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