6 months versus 12 months of adjuvant trastuzumab for patients with HER2-positive early breast cancer (PHARE): a randomised phase 3 trial
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Summary
This summary is machine-generated.Six months of adjuvant trastuzumab (HER2-positive early breast cancer treatment) was not found to be non-inferior to 12 months. The 12-month duration remains the standard of care despite higher cardiac event rates.
Area Of Science
- Oncology
- Cardiology
- Clinical Trials
Background
- 12 months of adjuvant trastuzumab is the standard for HER2-positive early breast cancer since 2005.
- The optimal duration of trastuzumab treatment remains a subject of debate.
- This study evaluated a shorter 6-month trastuzumab regimen against the standard 12-month duration.
Purpose Of The Study
- To determine if a 6-month duration of adjuvant trastuzumab is non-inferior to the standard 12-month duration for HER2-positive early breast cancer.
- To compare disease-free survival rates between the two treatment durations.
- To assess cardiac event rates associated with each treatment duration.
Main Methods
- An open-label, randomized, phase 3 trial involving 156 centers in France.
- Patients with HER2-positive early breast cancer received up to 6 months of trastuzumab before randomization.
- Patients were randomized to continue trastuzumab for 6 additional months (12 months total) or discontinue at 6 months.
- The primary endpoint was disease-free survival, with a non-inferiority margin of 1.15.
Main Results
- 1691 patients were assigned to the 12-month group and 1693 to the 6-month group.
- After a median follow-up of 42.5 months, disease-free survival events were 175 in the 12-month group and 219 in the 6-month group.
- Two-year disease-free survival was 93.8% for 12 months vs. 91.1% for 6 months (hazard ratio 1.28, p=0.29).
- Cardiac events occurred in 5.7% of the 12-month group versus 1.9% in the 6-month group (p<0.0001).
Conclusions
- The study failed to demonstrate non-inferiority for the 6-month trastuzumab treatment duration compared to 12 months.
- Despite increased cardiac events, 12 months of adjuvant trastuzumab should remain the standard of care.
- Further research may explore risk stratification for trastuzumab duration.