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

Sponsor:	Pfizer
Information provided by (Responsible Party):	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. Link to TEAM Trial [971-ONC-0028-081/A5991026] Study Results: http://clinicaltrials.gov/ct2/show/results/NCT00036270?term=971-ONC-0028-081&rank=1

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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
Study Completion Date:	June 2009
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Drug: exemestane On tablet of 25 mg per day during 5 years Other Name: Aromasin
Active Comparator: B	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 Other Name: Kessar

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 59 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 TEAM Trial [971-ONC-0028-081/A5991026] Study Results This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

van de Velde CJ, Rea D, Seynaeve C, Putter H, Hasenburg A, Vannetzel JM, Paridaens R, Markopoulos C, Hozumi Y, Hille ET, Kieback DG, Asmar L, Smeets J, Nortier JW, Hadji P, Bartlett JM, Jones SE. Adjuvant tamoxifen and exemestane in early breast cancer (TEAM): a randomised phase 3 trial. Lancet. 2011 Jan 22;377(9762):321-31.

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00279448 History of Changes
Other Study ID Numbers:	EXEAPO-0028-118, A5991081
Study First Received:	January 17, 2006
Last Updated:	December 22, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Adjuvants, Immunologic
Tamoxifen
Exemestane
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal

Antineoplastic Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Estrogen Antagonists
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012