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Six months of trastuzumab was almost as good as twelve, with half the heart toxicity, though twelve remains the global standard.
PERSEPHONE, trial NCT00712140 sponsored by Cancer Research UK and reported in 2019, showed that six months of adjuvant trastuzumab for HER2-positive early breast cancer was almost as good as twelve, with half the heart toxicity, though twelve months remains the global standard. It randomised 4,088 women and met its non-inferiority endpoint on four-year disease-free survival, with cardiac events requiring discontinuation in four percent against eight percent. OnCo links it to trastuzumab, the trastuzumab cardiotoxicity term, Helena Earl, Judith M. Bliss, Andrew Wardley, the bottleneck of wrong doses and the idea of funding trials of shorter courses of expensive adjuvant drugs. The other shorter-duration trials PHARE, SOLD and Short-HER did not establish non-inferiority, so most guidelines retain twelve months while accepting six where resources are limited.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
4,088 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| 4-year disease-free survivalprimary | 6 months trastuzumab | 2,043 | 89.4% | 1.07 (0.93 to 1.24) | - | link |
| 12 months trastuzumab | 2,045 | 89.8% |
Shares Early HER2-positive breast cancer, Wrong doses, Trastuzumab, HER2-positive breast cancer.
Shares Early HER2-positive breast cancer, Trastuzumab, HER2-positive breast cancer, Monoclonal antibodies.
Shares Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation, Trastuzumab, HER2-positive breast cancer, Monoclonal antibodies.
Shares Early HER2-positive breast cancer, Trastuzumab, HER2-positive breast cancer, Monoclonal antibodies.
Shares Intention-to-treat (ITT) and per-protocol analysis, Non-inferiority margin and equivalence trials, Non-inferiority trial.
Shares Early HER2-positive breast cancer, Trastuzumab, HER2-positive breast cancer, Monoclonal antibodies.
Shares Early HER2-positive breast cancer, HER2-positive breast cancer, Monoclonal antibodies.
Shares Intention-to-treat (ITT) and per-protocol analysis, Estimands and intercurrent events (ICH E9(R1)), Non-inferiority margin and equivalence trials, Non-inferiority trial.