Exemestane As Treatment In Neoadjuvant Setting For Operable Breast Cancer Patients

April 21, 2011 updated by: Pfizer

Phase II Study Evaluating The Role Of Exemestane On Clinical And Pathologic Response Rates, And Its Aromatase Activity As Treatment In Neoadjuvant Setting For Operable Breast Cancer Patients.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bordeaux, France
        • Pfizer Investigational Site
      • Clermont Ferrand, France
        • Pfizer Investigational Site
      • Montpellier, France
        • Pfizer Investigational Site
      • Poitiers Cedex, France
        • Pfizer Investigational Site
      • St. Cloud, France
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

April 22, 2011

Last Update Submitted That Met QC Criteria

April 21, 2011

Last Verified

April 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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