Tamoxifen and Exemestane Adjuvant Multicenter trial.
Completed
- Conditions
- Breast cancer.
- Registration Number
- NL-OMON22587
- Lead Sponsor
- Erasmus Medical Center - Daniel den Hoed Cancer CenterP.O. Box 52013008 AE ROTTERDAM
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 9000
Inclusion Criteria
1. Histologically/cytologically confirmed adenocarcinoma of the breast, followed by intended curative surgery (R0) and if indicated, also radiotherapy;
2. Any Tumor with a size > 3 cm, or Any N+ or tumor size 1-3 cm, N0 and one of the following factors: MAI > 10, Bloom-Richardson: grade 3, Any TNM stage BC considered to receive adjuvant hormonal therapy, as agreed by NABON-NVMO;
Exclusion Criteria
1. Inflammatory breast cancer, positive supraclavicular nodes, ulceration/infiltration of local skin metastasis;
2. Both ER negative and PgR negative primary tumor;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relapse Free Survival (RFS) at 2¾ years.
- Secondary Outcome Measures
Name Time Method Relapse Free Survival (RFS) at 5 years.