Phase 3
Completed N=9,779
Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane
Source: ClinicalTrials.gov NCT00036270 ↗Enrolled (actual)
9,779
Serious AEs
16.7%
Results posted
Dec 2009
Primary outcomePrimary: Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years — 352; 388 Events (disease relapse or death) — p=0.118
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years |
352; 388 | 0.118 |
| PRIMARY Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 5 Years |
712; 714 | 0.604 |
| SECONDARY Number of Events for Overall Survival (OS) |
485; 476 | 0.951 |
| SECONDARY Time to New Primary Breast Cancers |
— | — |
| SECONDARY Number of Events for Time to Relapse |
499; 521 | 0.293 |
| SECONDARY Number of Participants With New Primary Non-breast Cancers |
43; 32; 24; 17; 7; 17 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00036270). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.