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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00040014     History of Changes
Other Study ID Numbers: 971-ONC-0401-003
Study First Received: June 18, 2002
Last Updated: February 14, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Exemestane
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014