HERA
Trial question
Is one year of treatment with trastuzumab after adjuvant chemotherapy superior to observation in female patients with HER2+ breast cancer?
Study design
Multi-center
Open label
RCT
Population
3387 female patients.
Inclusion criteria: female patients with HER2+ breast cancer.
Key exclusion criteria: distant metastases, a previous invasive breast carcinoma, clinical stage T4 tumors, including inflammatory breast cancers or involvement of supraclavicular nodes.
Interventions
N=1694 trastuzumab (at a dose of 8 mg/kg of body weight IV once, then at a dose of 6 mg/kg every three weeks for 1 year).
N=1693 observation alone (no treatment).
Primary outcome
Recurrence of breast cancer, contralateral breast cancer, second nonbreast malignant cancer, or death
7.5%
13%
13.0 %
9.8 %
6.5 %
3.3 %
0.0 %
Trastuzumab
Observation
alone
Significant
decrease ▼
NNT = 18
Significant decrease in recurrence of breast cancer, contralateral breast cancer, second nonbreast malignant cancer, or death (7.5% vs. 13%; HR 0.54, 95% CI 0.43 to 0.67).
Secondary outcomes
No significant difference in death from any cause (1.7% vs. 2.2%; HR 0.76, 95% CI 0.47 to 1.23).
Significant decrease in distant recurrence (5% vs. 9.1%; HR 0.49, 95% CI 0.38 to 0.63).
Safety outcomes
Significant differences in severe congestive HF (0.54% vs. 0%, p = 0.002).
Conclusion
In female patients with HER2+ breast cancer, trastuzumab was superior to observation alone with respect to recurrence of breast cancer, contralateral breast cancer, second nonbreast malignant cancer, or death.
Reference
Piccart-Gebhart MJ, Procter M, Leyland-Jones B et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005 Oct 20;353(16):1659-72.
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