# DESTINY-Breast09

Source: https://onco.cc/trials/destiny-breast09/  
OnCo record `destiny-breast09` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Showed Enhertu plus pertuzumab beats the decade-old first-line standard for HER2-positive metastatic breast cancer.

## Summary

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-04
- Registry id: NCT04784715
- Phase: 3
- Setting: First-line HER2+ metastatic breast cancer: T-DXd + pertuzumab vs THP
- Sponsor: Daiichi Sankyo / AstraZeneca
- Enrolled: 1157
- Result: PFS HR 0.56.
- Outcomes: Progression-free survival (BICR), T-DXd + pertuzumab vs THP: Trastuzumab deruxtecan + pertuzumab 40.7 months vs Taxane + trastuzumab + pertuzumab 26.9 months, HR 0.56; Objective response rate: Trastuzumab deruxtecan + pertuzumab 85.1% vs Taxane + trastuzumab + pertuzumab 78.6%; Overall survival: Trastuzumab deruxtecan + pertuzumab vs Taxane + trastuzumab + pertuzumab
- Replication: Single pivotal trial versus the CLEOPATRA-era standard; the T-DXd monotherapy arm is still blinded. Consistent with the class's performance in DESTINY-Breast03.

## Sources

- ClinicalTrials.gov NCT04784715: https://clinicaltrials.gov/study/NCT04784715

## Connected records

- cancers: [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/), [Topoisomerase-I inhibitors (and ADC payloads)](https://onco.cc/technologies/topoisomerase-inhibitors/)
- drugs: [Pertuzumab](https://onco.cc/drugs/pertuzumab/), [Trastuzumab deruxtecan](https://onco.cc/drugs/trastuzumab-deruxtecan/)
- companies: [AstraZeneca](https://onco.cc/companies/astrazeneca/), [Daiichi Sankyo](https://onco.cc/companies/daiichi-sankyo/)
- people: [Cristina Saura](https://onco.cc/people/cristina-saura/), [Javier Cortés](https://onco.cc/people/javier-cortes/), [Sara M. Tolaney](https://onco.cc/people/sara-tolaney/)
- key papers: [Trastuzumab Deruxtecan plus Pertuzumab for HER2-Positive Metastatic Breast Cancer](https://onco.cc/key-papers/paper-destiny-breast09-n-engl-j-med-2026/)
- institutions: [Vall d'Hebron University Hospital / VHIO](https://onco.cc/institutions/vall-dhebron/)

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