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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:
ClinicalTrials.gov Identifier:
NCT00040014
First Posted: June 20, 2002
Last Update Posted: February 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
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.

Condition Intervention Phase
Breast Neoplasms Drug: exemestane Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

Estimated Enrollment: 100
Study Start Date: June 2002
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00040014


Locations
United Kingdom
Pfizer Investigational Site
Leicester, United Kingdom
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00040014     History of Changes
Other Study ID Numbers: 971-ONC-0401-003
First Submitted: June 18, 2002
First Posted: June 20, 2002
Last Update Posted: February 16, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Exemestane
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs