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Randomized Double-Blind Trial In Postmenopausal Women With Primary Breast Cancer Who Have Received Adjuvant Tamoxifen For 2-3 Years, Comparing Subsequent Adjuvant Exemestane Treatment With Further Tamoxifen


Phase 3
30 Years
N/A
Not Enrolling
Female
Breast Neoplasms

Thank you

Trial Information

Randomized Double-Blind Trial In Postmenopausal Women With Primary Breast Cancer Who Have Received Adjuvant Tamoxifen For 2-3 Years, Comparing Subsequent Adjuvant Exemestane Treatment With Further Tamoxifen


Inclusion Criteria:



- postmenopausal women with histologically or cytologically confirmed primary breast
adenocarcinoma, receiving tamoxifen and have been treated with tamoxifen continuously
for between 2 and 3 years and one month, and still free of disease

Exclusion Criteria:

- unresectable breast cancer

- ER negative primary tumor

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Disease Free Survival (DFS)

Outcome Time Frame:

June 2003, February 2006, December 2009, February 2013

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

96-OEXE-031

NCT ID:

NCT00038467

Start Date:

February 1998

Completion Date:

March 2013

Related Keywords:

  • Breast Neoplasms
  • Breast Neoplasms
  • Neoplasms

Name

Location

Pfizer Investigational SiteBirmingham, Alabama  35205
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteFlagstaff, Arizona  86001
Pfizer Investigational SiteAurora, Colorado  80012
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteCarmel, Indiana  46032
Pfizer Investigational SiteCedar Rapids, Iowa  52403
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteEugene, Oregon  97401