Exemestane As Treatment In Adjuvant For Post-Menopausal Patients With Non-Metastatic Breast Cancer - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00279448

Purpose

To compare recurrence free survival between two treatment groups (5 years with exemestane vs 2.5 to 3 years tamoxifen followed by 2 to 2.5 years of exemestane for a total duration of 5 years)

This Pfizer sponsored trial is part of an international collaboration of investigators conducting 7 similar yet independent studies in 9 countries. This study is designed to be part of the larger TEAM trial where the data from these 7 studies will be combined. A pre-specified analysis of the pooled data will be conducted.

Condition	Intervention	Phase
Breast Neoplasms	Drug: exemestane Drug: tamoxifen	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Multicenter, Randomized, Open-Label Study To Compare The Efficacy, Tolerance And Quality Of Life Of 5 Years Of Adjuvant Exemestane (Aromasin) Therapy With 2.5 To 3 Years Of Adjuvant Tamoxifen Therapy, Followed By 2 To 2.5 Years Of Exemestane For A Total Duration Of 5 Years To Treat HR+ Post-Menopausal Patients With Non-Metastatic Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Menopause

Drug Information available for: Tamoxifen Tamoxifen citrate Exemestane

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

To compare recurrence free survival between two treatment groups. [ Time Frame: 2.75 years and 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The quality of life of patients treated with exemestane to that of patients treated with tamoxifen [ Time Frame: Every 3 months during first year then every 6 months for 4 years ] [ Designated as safety issue: No ]
Overall survival between the 2 treatment groups [ Time Frame: Every 3 months during first year then every 6 months for 4 years ] [ Designated as safety issue: Yes ]
incidence of a second breast cancer (contralateral) between the 2 treatment groups [ Time Frame: Every 3 months during first year then every 6 months for 4 years ] [ Designated as safety issue: Yes ]
General tolerance in the short- and long-term between the 2 treatment groups [ Time Frame: Every 3 months during first year then every 6 months dor 4 years ] [ Designated as safety issue: Yes ]

Enrollment:	9779
Study Start Date:	January 2002
Estimated Study Completion Date:	September 2011
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: exemestane On tablet of 25 mg per day during 5 years
B: Active Comparator	Drug: tamoxifen Two tablets of tamoxifen 10 mg per day during 2.5 to 3 years followed by one tablet of exemestane 25 mg per day during 2 to 2.5 years for a total duration of 5 years of treatment

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HR+ post-menopausal patients with non-metastatic breast cancer

Exclusion Criteria:

Any of the following: HR-, non-menopausal patient, metastatic breast cancer

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00279448

Show 60 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to NCT00036270 (US Study Data Included) This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	EXEAPO-0028-118
Study First Received:	January 17, 2006
Last Updated:	November 2, 2009
ClinicalTrials.gov Identifier:	NCT00279448 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:

Estrogen Antagonists
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Breast Neoplasms
Enzyme Inhibitors
Bone Density Conservation Agents

Selective Estrogen Receptor Modulators
Tamoxifen
Pharmacologic Actions
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Exemestane
Aromatase Inhibitors
Breast Diseases

ClinicalTrials.gov processed this record on November 09, 2009