Status:
ACTIVE_NOT_RECRUITING
Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09)
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Daiichi Sankyo
Conditions:
Breast Cancer; HER2-positive; Metastatic
Eligibility:
All Genders
18-130 years
Phase:
PHASE3
Brief Summary
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 gro...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Key
- Patients must be ≥18 years of age
- Pathologically documented breast cancer that:
- is advanced or metastatic
- is locally assessed and prospectively centrally confirmed as HER2-positive (IHC3+ or ISH+)
- is documented by local testing as hormone receptor (HR)-positive or HR-negative disease in the metastatic setting
- No prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer or only 1 previous line of endocrine therapy in the metastatic setting. Participants who have received chemotherapy or HER2-targeted therapy in the neo-adjuvant or adjuvant setting are eligible if \> 6 months from treatment to metastatic diagnosis.
- Has protocol-defined adequate organ and bone marrow function
- ECOG performance status 0 or 1
- Key
Exclusion
- Ineligible for any of the agents on the study.
- Any substance abuse or other medical conditions that, in the investigator's opinion, may interfere with subject's participation or study results
- Patients with spinal cord compression or clinically active central nervous system metastases. Participants with clinically inactive brain metastases or treated brain metastases that are no longer symptomatic may be included in the study.
- Active or prior documented interstitial lung disease (ILD)/pneumonitis or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
- Prior randomization or treatment in a previous trastuzumab deruxtecan study regardless of treatment arm assignment
Key Trial Info
Start Date :
April 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2029
Estimated Enrollment :
1157 Patients enrolled
Trial Details
Trial ID
NCT04784715
Start Date
April 26 2021
End Date
December 30 2029
Last Update
November 12 2025
Active Locations (283)
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1
Research Site
Tucson, Arizona, United States, 85711
2
Research Site
Springdale, Arkansas, United States, 72762
3
Research Site
Glendale, California, United States, 91204
4
Research Site
Glendale, California, United States, 91206