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Showed Enhertu plus pertuzumab beats the decade-old first-line standard for HER2-positive metastatic breast cancer.
DESTINY-Breast09, trial NCT04784715 sponsored by Daiichi Sankyo and AstraZeneca and reported in 2025, showed that trastuzumab deruxtecan plus pertuzumab beats the decade-old first-line standard of a taxane, trastuzumab and pertuzumab for HER2-positive metastatic breast cancer. It randomised 1,157 patients across three arms, met its primary progression-free survival endpoint by blinded review for the combination against THP with a large effect and a higher response rate, with overall survival immature but trending favourably, while the trastuzumab deruxtecan monotherapy arm remained blinded. OnCo links it to HER2-positive breast cancer, trastuzumab deruxtecan, pertuzumab, Cristina Saura, Javier Cortés, Sara M. Tolaney and Vall d'Hebron. It replaces the CLEOPATRA-era regimen, and whether the ADC alone would do as well as the combination is the question the blinded arm will answer.
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.
1,157 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (BICR), T-DXd + pertuzumab vs THPprimary | Trastuzumab deruxtecan + pertuzumab | 383 | 40.7 months | 0.56 (0.44 to 0.71) | <0.00001 | link |
| Taxane + trastuzumab + pertuzumab | 387 | 26.9 months | ||||
| Objective response rate | Trastuzumab deruxtecan + pertuzumab | - | 85.1% | - | - | link |
| Taxane + trastuzumab + pertuzumab | - | 78.6% | ||||
| Overall survival | Trastuzumab deruxtecan + pertuzumab | - | Immature at the interim analysis; early trend favoured T-DXd + pertuzumab. | - | - | link |
| Taxane + trastuzumab + pertuzumab | - | - |
Shares Pertuzumab, Daiichi Sankyo, Trastuzumab deruxtecan, Topoisomerase-I inhibitors (and ADC payloads).
Shares Daiichi Sankyo, Trastuzumab deruxtecan, Topoisomerase-I inhibitors (and ADC payloads), AstraZeneca.
Shares Javier Cortés, Vall d'Hebron University Hospital / VHIO, Daiichi Sankyo, Trastuzumab deruxtecan.
Shares Daiichi Sankyo, Trastuzumab deruxtecan, Topoisomerase-I inhibitors (and ADC payloads), AstraZeneca.
Shares Daiichi Sankyo, Trastuzumab deruxtecan, Topoisomerase-I inhibitors (and ADC payloads), AstraZeneca.
Shares Daiichi Sankyo, Trastuzumab deruxtecan, Topoisomerase-I inhibitors (and ADC payloads), Antibody-drug conjugate (ADC).
Shares Daiichi Sankyo, Trastuzumab deruxtecan, Topoisomerase-I inhibitors (and ADC payloads), Antibody-drug conjugate (ADC).
Shares Daiichi Sankyo, Trastuzumab deruxtecan, Topoisomerase-I inhibitors (and ADC payloads), AstraZeneca.