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Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer

Last updated on August 9, 2018

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35205 United States
Contact
1-800-718-1021
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
30+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

- unresectable breast cancer

- ER negative primary tumor

NCT00038467
Pfizer
Completed
Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer

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Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer
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
To compare the sequential administration of exemestane with administration of further tamoxifen until 5 years in postmenopausal women with operable breast cancer who have already received 2-3 years of adjuvant tamoxifen, in terms of disease-free survival (DFS), overall survival (OS), incidence of contralateral breast cancer and long-term tolerability.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Breast Neoplasms
  • Drug: Tamoxifen
    Tamoxifen 20 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.
  • Drug: Exemestane
    Exemestane 25 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.
  • Active Comparator: B
    Intervention: Drug: Tamoxifen
  • Experimental: A
    Intervention: Drug: Exemestane
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4740
March 2013
June 2003   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
30 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Belgium,   Bosnia and Herzegovina,   Bulgaria,   Croatia,   Czech Republic,   Denmark,   Egypt,   Estonia,   France,   Germany,   Greece,   Hong Kong,   Hungary,   Ireland,   Israel,   Italy,   Luxembourg,   Malta,   Netherlands,   New Zealand,   Norway,   Peru,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Slovakia,   Slovenia,   South Africa,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Former Serbia and Montenegro,   Montenegro
 
NCT00038467
96-OEXE-031
A5991012
Yes
Not Provided
Not Provided
Pfizer
Pfizer
International Collaborative Cancer Group (ICCG)
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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