Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane - Full Text View

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00036270

Purpose

To compare the effects of exemestane for 5 years versus tamoxifen and exemestane given sequentially over 5 years in the adjuvant treatment of postmenopausal women with early breast cancer.

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 (Aromasin) Drug: tamoxifen + exemestane	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:	Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen For 2.5- 3 Years Followed By Exemestane (Aromasin) For A Total Of 5 Years As Adjuvant Therapy For Postmenopausal, Receptor Positive, Node Negative or Node Positive Breast Cancer Patients

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Tamoxifen Tamoxifen citrate Exemestane

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years [ Time Frame: Baseline (Month 0) up to 2.75 years ] [ Designated as safety issue: No ]
Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 2.75 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse.
Disease Free Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
The Incidence of New Primary Breast Cancers of the Postmenopausal Women Treated With 5 Years of Exemestane (Aromasin) Versus Tamoxifen Therapy for 2.5- 3 Years Followed by 2.5- 2 Years of Exemestane (Aromasin). [ Time Frame: 2.75 years; 5 years ] [ Designated as safety issue: No ]
Summary of Adverse Events: Overall Number of Subjects Affected for Adverse Events and Serious Adverse Events [ Time Frame: Baseline up to 5 years ] [ Designated as safety issue: Yes ]

Enrollment:	9779
Study Start Date:	August 2001
Study Completion Date:	February 2011
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: exemestane	Drug: exemestane (Aromasin) exemestane, orally, 25 mg, for 5 years Other Name: aromasin
Experimental: tamoxifen + exemestane	Drug: tamoxifen + exemestane tamoxifen, 20 mg, orally, daily, 2-3 years; followed by exemestane, orally, 25 mg, for a total of 5 years of therapy

Eligibility

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

Criteria

Inclusion Criteria:

Histologically/cytologically confirmed adenocarcinoma of the breast, followed by adequate surgical resection and/or radiotherapy, and/or adjuvant chemotherapy, if indicated.
Stage T1-3 N0-2 Mo, Any TNM stage BC for whom adjuvant hormonal therapy is being considered.

Exclusion Criteria:

Those patients not deemed to have had potentially curative primary surgical treatment or one of the following criteria:
Inflammatory breast cancer
Histologically positive supraclavicular nodes
Ulceration/infiltration of local skin metastasis
Neoadjuvant chemotherapy
Ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) without invasion
ER and PR negative primary tumor or ER/PR unknown status.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036270

Show 179 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

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:	NCT00036270 History of Changes
Other Study ID Numbers:	971-ONC-0028-081, A5991026
Study First Received:	May 8, 2002
Results First Received:	October 30, 2009
Last Updated:	September 13, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Tamoxifen
Exemestane
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012