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Open Label, Multicenter, Randomized, Controlled Study of IM or Oral Exemestane (Aromasin) in Postmenopausal Women
This study has been terminated.
Study NCT00040014   Information provided by Pfizer
First Received: June 18, 2002   Last Updated: November 10, 2006   History of Changes

June 18, 2002
November 10, 2006
June 2002
 
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.
Same as current
Complete list of historical versions of study NCT00040014 on ClinicalTrials.gov Archive Site
  • 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 pharmakokinetics and pharmacodynamics after intramuscular and oral administration of exemestane
  • to evaluate the effcacy (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
Same as current
 
Open Label, Multicenter, Randomized, Controlled Study of IM or Oral Exemestane (Aromasin) in Postmenopausal Women
Open Label, Multicenter, Randomized, Controlled Study of IM or Oral Exemestane (Aromasin) in Postmenopausal Women With Advanced Breast Cancer Having Progressed on Tamoxifen.

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.

 
Phase II
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Breast Neoplasms
Drug: exemestane
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
100
 
 

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00040014
 
971-ONC-0401-003
Pfizer
 
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP