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Randomized Phase III Study Of...

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

Last Updated: 2015-10-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

9779 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2011-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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exemestane

Group Type EXPERIMENTAL

exemestane (Aromasin)

Intervention Type DRUG

exemestane, orally, 25 mg, for 5 years

tamoxifen + exemestane

Group Type EXPERIMENTAL

tamoxifen + exemestane

Intervention Type DRUG

tamoxifen, 20 mg, orally, daily, 2-3 years; followed by exemestane, orally, 25 mg, for a total of 5 years of therapy

Interventions

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exemestane (Aromasin)

exemestane, orally, 25 mg, for 5 years

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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aromasin

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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