HERA
A Randomized Three-Arm, Multicenter Comparison of 1 Year and 2 Years of Herceptin Versus No Herceptin in Women With HER2-Positive Primary Breast Cancer Who Have Completed Adjuvant Chemotherapy
Phase 3NCT00045032
- Population
- HER2-positive, node-negative or node-positive early breast cancer after locoregional therapy and at least four cycles of chemotherapy
- Design
- International, multicentre, randomised trial comparing one or two years of trastuzumab every three weeks with observation after completion of locoregional therapy and at least four cycles of neoadjuvant or adjuvant chemotherapy. The first report analyses one year of trastuzumab versus observation only.
- Arms
- Observation (control, n = 1,693): No further trastuzumab after completed chemotherapy
- Trastuzumab for one year (experimental, n = 1,694): Trastuzumab every three weeks for one year
- Trastuzumab for two years (experimental, n = 1,694): Trastuzumab every three weeks for two years (not analysed in the first report)
- People
- Piccart-Gebhart MJ
DFSHR 0.54 (95% CI 0.43–0.67)
Show the numbers
| Endpoint | Analysis | Trastuzumab for one year / Trastuzumab for two years | Observation | Effect |
|---|---|---|---|---|
| DFSOne year of trastuzumab versus observationEvents: recurrence of breast cancer, contralateral breast cancer, second non-breast malignant disease, or death | interimPiccart-Gebhart 2005 | — | — | HR 0.54 (95% CI 0.43–0.67)P<0.0001First planned interim analysis at a median follow-up of one year (stated in words in the abstract); 347 events (127 in the trastuzumab group, 220 in the observation group). Unadjusted hazard ratio; the boundary for the interim analysis was crossed. Absolute disease-free survival benefit at two years: 8.4 percentage points. |
| Endpoint | Analysis | Trastuzumab for one year / Trastuzumab for two years | Observation | Effect |
|---|---|---|---|---|
| DFSOne year of trastuzumab versus observationEvents: recurrence of breast cancer, contralateral breast cancer, second non-breast malignant disease, or death | interimPiccart-Gebhart 2005 | — | — | HR 0.54 (95% CI 0.43–0.67)P<0.0001First planned interim analysis at a median follow-up of one year (stated in words in the abstract); 347 events (127 in the trastuzumab group, 220 in the observation group). Unadjusted hazard ratio; the boundary for the interim analysis was crossed. Absolute disease-free survival benefit at two years: 8.4 percentage points. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| DFS | 0.54 | 0.43–0.67 |