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Exemestane As Treatment In Neoadjuvant Setting For Operable Breast Cancer Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00174343
First Posted: September 15, 2005
Last Update Posted: April 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  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
Intervention Model: Single Group Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00174343     History of Changes
Other Study ID Numbers: 971-ONC-0028-095
First Submitted: September 9, 2005
First Posted: September 15, 2005
Last Update Posted: April 22, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Exemestane
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs