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

Condition(s) targeted: Breast Neoplasms

Intervention: exemestane (Aromasin) (Drug); tamoxifen + exemestane (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer Oncology Clinical Trial Information Service, Phone: 1-877-369-9753, Email: PfizerCancerTrials@emergingmed.com

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.

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

Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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.

Secondary outcome:

Overall survival

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).

The relative safety profiles

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Female.

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.

Pfizer Oncology Clinical Trial Information Service, Phone: 1-877-369-9753, Email: PfizerCancerTrials@emergingmed.com

Pfizer Investigational Site, Dallas, Texas 75204, United States

To obtain contact information for a study center near you, click here.

Starting date: October 2001
Ending date: October 2008
Last updated: October 23, 2008