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

Hide Study Locations

Locations

France
Pfizer Investigational Site
Neuilly, France, 92200
Pfizer Investigational Site
Paris, France, 75248
Pfizer Investigational Site
Mareuil Les Meaux, France
Pfizer Investigational Site
Quincy Sous Senart, France, 91480
Pfizer Investigational Site
Ris Orangis, France, 91130
Pfizer Investigational Site
St Cloud, France, 92210
Pfizer Investigational Site
Saint Brieuc, France, 22105
Pfizer Investigational Site
Vannes, France, 56000
Pfizer Investigational Site
Nantes Cedex 2, France, 44202
Pfizer Investigational Site
Saint-Herblain, France, 44805
Pfizer Investigational Site
Evreux, France, 27000
Pfizer Investigational Site
Rouen, France, 76000
Pfizer Investigational Site
Blois, France, 41000
Pfizer Investigational Site
Le Havre, France, 76600
Pfizer Investigational Site
Metz, France, 57072
Pfizer Investigational Site
Lorient, France
Pfizer Investigational Site
St Herblain, France, 44805
Pfizer Investigational Site
Lille, France, 59000
Pfizer Investigational Site
Croix, France, 59170
Pfizer Investigational Site
Nancy, France, 54000
Pfizer Investigational Site
Amiens, France, 80000
Pfizer Investigational Site
Chaumont, France, 52000
Pfizer Investigational Site
Dijon, France, 21000
Pfizer Investigational Site
Chalon Sur Saone, France, 71100
Pfizer Investigational Site
Dunkerque, France, 59140
Pfizer Investigational Site
Douai, France, 59500
Pfizer Investigational Site
Vandoeuvre Les Nancy, France, 54511
Pfizer Investigational Site
Reims, France, 51100
Pfizer Investigational Site
Brest, France, 29283
Pfizer Investigational Site
Montbeliard, France, 25200
Pfizer Investigational Site
Nice Cedex 1, France, 06050
Pfizer Investigational Site
Avignon Cedex 2, France, 84082
Pfizer Investigational Site
Nimes, France, 30900
Pfizer Investigational Site
Hyres, France, 83400
Pfizer Investigational Site
Mougins, France, 06250
Pfizer Investigational Site
Cagne Sur Mer, France, 06805
Pfizer Investigational Site
Lyon, France, 69008
Pfizer Investigational Site
Annecy Cedex, France, 74011
Pfizer Investigational Site
Marseille, France, 13012
Pfizer Investigational Site
Marseille, France, 13006
Pfizer Investigational Site
Marseille, France, 13009
Pfizer Investigational Site
Draguignan, France, 83007
Pfizer Investigational Site
Aix En Provence, France, 13616
Pfizer Investigational Site
Toulon, France, 83056
Pfizer Investigational Site
Montpellier, France, 34059
Pfizer Investigational Site
Montelimar, France, 26026
Pfizer Investigational Site
Bordeaux Cedex, France, 33000
Pfizer Investigational Site
Toulouse, France, 31000
Pfizer Investigational Site
L'Union, France, 31240
Pfizer Investigational Site
Bayonne, France, 64100
Pfizer Investigational Site
Montauban, France, 82017
Pfizer Investigational Site
Toulouse, France, 31400
Pfizer Investigational Site
Pessac, France, 33600
Pfizer Investigational Site
Bordeaux, France, 33076
Pfizer Investigational Site
Strasbourg, France
France, BE1 01971
Pfizer Investigational Site
Marseille, BE1 01971, France, 13285
France, BE1 02256
Pfizer Investigational Site
Compiegne, BE1 02256, France, 60200
France, BE1 03677
Pfizer Investigational Site
Rennes, BE1 03677, France, 35033
France, BE1 04292
Pfizer Investigational Site
Brest, BE1 04292, France, 29609

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 20, 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 27, 2009