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

Pfizer

Status and phase

Completed

Phase 3

Conditions

Breast Neoplasms

Treatments

Drug: tamoxifen + exemestane

Drug: exemestane (Aromasin)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00036270

971-ONC-0028-081

A5991026

Details and patient eligibility

About

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.

Enrollment

9,779 patients

Sex

Female

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.