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

Sponsored by:	Pfizer
Information provided by:	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

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

To determine whether adjuvant treatment with exemestane improves the disease-free survival of postmenopausal, receptor positive, node negative or node positive breast cancer patients compared with adjuvant tamoxifen therapy at 2.75 and 5 years. [ Time Frame: 2.75 years; 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 ]
The relative safety profiles [ Time Frame: 2.75 years; 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	2400
Study Start Date:	October 2001
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
exemestane: Experimental	Drug: exemestane (Aromasin) exemestane, orally, 25 mg, for 5 years
tamoxifen + exemestane: Experimental	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

Locations

United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75204

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:	971-ONC-0028-081, A5991012
Study First Received:	May 8, 2002
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00036270
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Exemestane
Tamoxifen
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 January 16, 2009