| May 8, 2002 |
| September 10, 2009 |
| October 2001 |
| December 2010 (final data collection date for primary outcome measure) |
| 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 ] |
| To determine whether adjuvant treatment with exemestane improves the relapse-free survival (RFS) of postmenopausal, receptor positive, node negative or node positive breast cancer patients compared with adjuvant tamoxifen therapy for 2.75 years, which is |
| Complete list of historical versions of study NCT00036270 on ClinicalTrials.gov Archive Site |
- 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 ]
|
| RFS, overall survival, the relative safety profiles, and the incidence of new primary breast cancers of the postmenopausal women treated with 5 years of exemestane versus tamoxifen therapy for 2.5- 3 years followed by 2.5- 2 years of exemestane (a total |
| |
| Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane |
| 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 |
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. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Breast Neoplasms |
- Drug: exemestane (Aromasin)
- Drug: tamoxifen + exemestane
|
| |
| |
| |
| Active, not recruiting |
| 2400 |
| December 2010 |
| December 2010 (final data collection date for primary outcome measure) |
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.
|
| Female |
| 50 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00036270 |
| Director, Clinical Trial Disclosure Group, Pfizer Inc |
| 971-ONC-0028-081, A5991026 |
| Pfizer |
|
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
|
| Pfizer |
| September 2009 |
