Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00174343 |
Date of registration:
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09/09/2005 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Exemestane As Treatment In Neoadjuvant Setting For Operable Breast Cancer Patients
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Scientific title:
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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. |
Date of first enrolment:
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November 2001 |
Target sample size:
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46 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00174343 |
Study type:
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Interventional |
Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Pfizer CT.gov Call Center |
Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Neoplasms
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Intervention(s)
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Drug: exemestane (Aromasin®)
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Primary Outcome(s)
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To evaluate clinical and pathologic response rates following primary hormonal therapy by exemestane (Aromasin®)
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Secondary Outcome(s)
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To evaluate breast conservative surgery rate; To evaluate intratumoral anti-aromatase activity.
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Secondary ID(s)
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971-ONC-0028-095
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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