Exemestane As Treatment In Neoadjuvant Setting For Operable Breast Cancer Patients

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00174343
First received: September 9, 2005
Last updated: April 21, 2011
Last verified: April 2011
  Purpose

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


Condition Intervention Phase
Breast Neoplasms
Drug: exemestane (Aromasin®)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

Secondary Outcome Measures:
  • To evaluate breast conservative surgery rate; To evaluate intratumoral anti-aromatase activity.

Estimated Enrollment: 46
Study Start Date: November 2001
Study Completion Date: September 2006
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174343

Locations
France
Pfizer Investigational Site
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
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00174343     History of Changes
Other Study ID Numbers: 971-ONC-0028-095
Study First Received: September 9, 2005
Last Updated: April 21, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Exemestane
Antineoplastic Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014