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NCT00174343 Clinical Trial

Exemestane As Treatment In Neoadjuvant Setting For Operable Breast Cancer Patients

Breast Neoplasms Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00174343
Other study ID # 971-ONC-0028-095
Secondary ID
Status Completed
Phase Phase 2
First received September 9, 2005
Last updated April 21, 2011
Start date November 2001
Est. completion date September 2006

Study information
Verified date April 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 46
Est. completion date September 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• exemestane (Aromasin®)

Locations
Country Name City State
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

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate clinical and pathologic response rates following primary hormonal therapy by exemestane (Aromasin®)
Secondary To evaluate breast conservative surgery rate; To evaluate intratumoral anti-aromatase activity.
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