Study identifier:D967UC00001
ClinicalTrials.gov identifier:NCT04784715
EudraCT identifier:2020-004074-21
CTIS identifier:2023-507904-30-00
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)
Breast Cancer; HER2-positive; metastatic
Phase 3
No
Trastuzumab deruxtecan, Placebo, Taxane, Pertuzumab, Trastuzumab
All
1157
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 May 2025 by AstraZeneca
AstraZeneca
Daiichi Sankyo
The study will evaluate the efficacy and safety of trastuzumab deruxtecan (also known as T-DXd, DS-8201a), either alone or in combination with pertuzumab, in treating patients with Human epidermal growth factor receptor 2 (HER2)-positive breast cancer as a first line of treatment in the metastatic setting.
Eligible participants will be those diagnosed with HER2-positive (IHC 3+ or ISH+), metastatic breast cancer, who have received no prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer. The study aims to evaluate the efficacy, and safety of trastuzumab deruxtecan, alone or with pertuzumab, compared with the standard of care treatment (taxane [docetaxel or paclitaxel], trastuzumab and pertuzumab). This study aims to see if trastuzumab deruxtecan allows patients to live longer without the cancer getting worse, or simply to live longer, compared to patients receiving standard of care chemotherapy. This study is also looking to see how the treatment and the cancer affects patients' quality of life.
Location
Location
Port Elizabeth, South Africa, 6045
Location
Rondebosch, South Africa, 7700
Location
Johannesburg, South Africa, 2193
Location
Cape Town, South Africa, 7570
Location
Pretoria, South Africa, 0081
Location
George, South Africa, 6529
Location
Dammam, Saudi Arabia, 31444
Location
Riyadh, Saudi Arabia, 11211
Arms | Assigned Interventions |
---|---|
Experimental: Arm A Trastuzumab deruxtecan (T-DXd) plus pertuzumab-matching placebo | Drug: Trastuzumab deruxtecan Administered by intravenous infusion Other Name: DS-8201a; T-DXd Drug: Placebo Administered by intravenous infusion |
Experimental: Arm B Trastuzumab deruxtecan (T-DXd) plus pertuzumab | Drug: Trastuzumab deruxtecan Administered by intravenous infusion Other Name: DS-8201a; T-DXd Drug: Pertuzumab Administered by intravenous infusion |
Active Comparator: Arm C Standard of care (Taxane (paclitaxel or docetaxel), trastuzumab, and pertuzumab) | Drug: Taxane Investigator's choice of docetaxel or paclitaxel administered by intravenous infusion Drug: Pertuzumab Administered by intravenous infusion Drug: Trastuzumab Administered by intravenous infusion |
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