Exemestane As Treatment In Neoadjuvant Setting For Operable Breast Cancer Patients

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NCT00174343

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Study Location
Pfizer Investigational Site
Bordeaux, , , France
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Exemestane As Treatment In Neoadjuvant Setting For Operable Breast Cancer Patients
Official Title  ICMJE 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.
Brief Summary To evaluate clinical and pathologic response rates following primary hormonal therapy by exemestane (Aromasin®)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE Drug: exemestane (Aromasin®)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 9, 2005)		46
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00174343
Other Study ID Numbers  ICMJE 971-ONC-0028-095
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP