- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00174343
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
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
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Bordeaux, France
- Pfizer Investigational Site
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Clermont Ferrand, France
- Pfizer Investigational Site
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Montpellier, France
- Pfizer Investigational Site
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Poitiers Cedex, France
- Pfizer Investigational Site
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St. Cloud, France
- Pfizer Investigational Site
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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 |
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To evaluate clinical and pathologic response rates following primary hormonal therapy by exemestane (Aromasin®)
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Secondary Outcome Measures
Outcome Measure |
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To evaluate breast conservative surgery rate; To evaluate intratumoral anti-aromatase activity.
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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
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Exemestane
Other Study ID Numbers
- 971-ONC-0028-095
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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Clinical Trials on exemestane (Aromasin®)
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Roxane LaboratoriesCompletedBreast CancerUnited States
-
Roxane LaboratoriesCompleted
-
PfizerTerminated