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Open Label, Multicenter, Randomized, Controlled Study of IM or Oral Exemestane (Aromasin) in Postmenopausal Women

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00040014
First received: June 18, 2002
Last updated: February 14, 2012
Last verified: February 2012
History of Changes

June 18, 2002
February 14, 2012
June 2002
December 2006   (final data collection date for 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.
Not Provided
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 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
Not Provided
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Neoplasms
Drug: exemestane
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
100
December 2006
December 2006   (final data collection date for primary outcome measure)

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
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2012

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