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

Tracking Information

First Received Date ^ICMJE

June 18, 2002

Last Updated Date

November 10, 2006

Start Date ^ICMJE

June 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00040014 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 pharmakokinetics and pharmacodynamics after intramuscular and oral administration of exemestane
to evaluate the effcacy (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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Open Label, Multicenter, Randomized, Controlled Study of IM or Oral Exemestane (Aromasin) in Postmenopausal Women With Advanced Breast Cancer Having Progressed on Tamoxifen.

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Breast Neoplasms

Intervention ^ICMJE

Drug: exemestane

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

100

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00040014

Responsible Party

Study ID Numbers ^ICMJE

971-ONC-0401-003

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

November 2006

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