Info
Tamoxifen and Exemestane Trial
July 10, 2014 N Engl J Med 2014; 371:107-118 DOI: 10.1056/NEJMoa1404037
- Design: Two phase 3 trials.
- Number of patients: 4690 patients in the two trials.
- Patients characteristics: Premenopausal women with hormone-receptor-positive early breast cancer.
- Agents: Exemestane, a aromatase inhibitor, and tamoxifen.
- Treatment line: Adjuvant therapy after surgery.
- Trial Name/NCT Number: TEXT and SOFT, NCT00066703 and NCT00066690, respectively.
- Comparison of two groups in a markdown table:
| Group/Outcome | Exemestane + ovarian suppression | Tamoxifen + ovarian suppression |
|---|---|---|
| 5-year disease-free survival rate | 91.1% | 87.3% |
| Hazard ratio for disease recurrence, second invasive cancer, or death | 0.72 (95% CI, 0.60 to 0.85) | Not reported |
| P value | <0.001 | Not reported |
| 5-year rate of freedom from breast cancer | 92.8% | 88.8% |
| Hazard ratio for recurrence | 0.66 (95% CI, 0.55 to 0.80) | Not reported |
| P value | <0.001 | Not reported |
| Overall survival | No significant difference between the two groups (hazard ratio for death in the exemestane-ovarian suppression group, 1.14; 95% CI, 0.86 to 1.51; P=0.37) | Not reported |
| Selected adverse events of grade 3 or 4 | 30.6% | 29.4% |
Note: Specific details of the ovarian suppression methods used are not provided.