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

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: tamoxifen Drug: exemestane	Phase III

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

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

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:

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 ]
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 ]

Estimated Enrollment:	1379
Study Start Date:	January 2002
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	October 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

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

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	EXEAPO-0028-118, A5991081
First Received:	January 17, 2006
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00279448
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Skin Diseases

Quality of Life

Breast Neoplasms

Exemestane

Tamoxifen

Menopause

Breast Diseases

Additional relevant MeSH terms:

Estrogen Antagonists

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents, Hormonal

Antineoplastic Agents

Hormone Antagonists

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Enzyme Inhibitors

Bone Density Conservation Agents

Selective Estrogen Receptor Modulators

Pharmacologic Actions

Estrogen Receptor Modulators

Neoplasms

Neoplasms by Site

Therapeutic Uses

Aromatase Inhibitors

ClinicalTrials.gov processed this record on October 24, 2008

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