NCT00040014

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2002

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2002

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

February 16, 2012

Status Verified

February 1, 2012

Enrollment Period

4.5 years

First QC Date

June 18, 2002

Last Update Submit

February 14, 2012

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Interventions

exemestaneDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • other diagnosed with breast cancer
  • estrogen receptor positivity
  • Postmenopausal status
  • advanced disease
  • progression to previous tamoxifen therapy

You may not qualify if:

  • more than 1 chemotherapy and / or more than 1 hormonotherapy for advanced disease
  • previous hormonotherapy other than Tamoxifen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Leicester, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestane

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2002

First Posted

June 20, 2002

Study Start

June 1, 2002

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

February 16, 2012

Record last verified: 2012-02

Locations

GB(1)