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

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. Identifier: NCT00040014
Recruitment Status : Terminated
First Posted : June 20, 2002
Last Update Posted : February 16, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: exemestane Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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.
Study Start Date : June 2002
Primary Completion Date : December 2006
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Exemestane
U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. to characterize the pharmacodynamic profile of the two formulations in terms of estrogens, androgens, and sec hormone binding globulin
  2. to characterize the pharmacokinetics of exemestane and 17 hydroexemestane after administration of the two formulations
  3. to evaluate the relationships between pharmacokinetics and pharmacodynamics after intramuscular and oral administration of exemestane
  4. to evaluate the efficacy (as tumor response)
  5. to evaluate the incidence and severity of systemic toxicities and of the local tolerability of the injectable formulation
  6. to evaluate the effect on serum bone turnover markers

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

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

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 identifier (NCT number): NCT00040014

United Kingdom
Pfizer Investigational Site
Leicester, United Kingdom
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
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