NCT04784715: Phase 3: (DESTINY-Breast09) Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer

First Posted	2020-10-19
Trial status	Active, not recruiting
Sponsor	AstraZeneca
Abstract Presentation	Meeting Abstract: 2025 ASCO Annual Meeting II Free access Breast Cancer—Metastatic June 04, 2025 Trastuzumab deruxtecan (T-DXd) + pertuzumab (P) vs taxane + trastuzumab + pertuzumab (THP) for first-line (1L) treatment of patients (pts) with human epidermal growth factor receptor 2–positive (HER2+) advanced/metastatic breast cancer (a/mBC): Interim results from DESTINY-Breast09 Click here for details
Peer-reviewed journal publication	Trastuzumab Deruxtecan plus Pertuzumab for HER2-Positive Metastatic Breast Cancer N Engl J Med. 2025 Oct 29. PUBMED NEJM
FDA	FDA approves fam-trastuzumab deruxtecan-nxki with pertuzumab for unresectable or metastatic HER2-positive breast cancer December 15, 2025 Click here for details Enhertu plus pertuzumab granted Priority Review in the US as 1st-line treatment for patients with HER2-positive metastatic breast cancer September, 24, 2025 Click here for details
Press Release	ENHERTU® Plus Pertuzumab Approved in the U.S. as First New Treatment in More Than a Decade for First-Line Treatment of Patients with HER2 Positive Metastatic Breast Cancer December 15, 2025 Click here for details Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% vs. THP as 1st-line therapy in patients with HER2-positive metastatic breast cancer in DESTINY-Breast09 Phase III trial June 2nd, 2025 Click here for details
NCCN

NCT04784715: Phase 3: (DESTINY-Breast09) Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer

(Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09))

Official Title:

Phase III Study of Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive, First-line Metastatic Breast Cancer (DESTINY-Breast09)

Intervention / Treatment:

Drug: Trastuzumab deruxtecan

Drug: Placebo

Drug: Taxane

Drug: Pertuzumab

Drug: Trastuzumab

Other Study ID Numbers:

D967UC00001

2023-507904-30-00 ( Registry Identifier ) (REGISTRY: CTIS (EU))

2020-004074-21 ( EudraCT Number )

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