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

Phase 2

Terminated

• Conditions: Breast Neoplasms

• Registration Number: NCT00040014
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2002-06-18
• Study First Submitted QC: 2002-06-19
• Study First Posted: 2002-06-20
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-14
• Last Update Posted: 2012-02-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Leicester, United Kingdom