NCT00174343

Brief Summary

To evaluate clinical and pathologic response rates following primary hormonal therapy by exemestane (Aromasin®)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2001

Longer than P75 for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

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

November 1, 2001

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

April 22, 2011

Status Verified

April 1, 2011

First QC Date

September 9, 2005

Last Update Submit

April 21, 2011

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

  • To evaluate clinical and pathologic response rates following primary hormonal therapy by exemestane (Aromasin®)

Secondary Outcomes (1)

  • To evaluate breast conservative surgery rate; To evaluate intratumoral anti-aromatase activity.

Interventions

exemestane (Aromasin®)DRUG

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Post-menopausal patients with unilateral breast cancer T2 to T4, N0-1, M0, non inflammatory, operable, hormonal receptors positive

You may not qualify if:

  • Patients with bilateral breast cancer T4d, inflammatory, non operable, hormonal receptors negative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Pfizer Investigational Site

Bordeaux, France

Location

Pfizer Investigational Site

Clermont-Ferrand, France

Location

Pfizer Investigational Site

Montpellier, France

Location

Pfizer Investigational Site

Poitiers, France

Location

Pfizer Investigational Site

Saint-Cloud, France

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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

November 1, 2001

Study Completion

September 1, 2006

Last Updated

April 22, 2011

Record last verified: 2011-04

Locations

FR(5)