Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09)
Trastuzumab deruxtecan: Administered by intravenous infusion
Placebo: Administered by intravenous infusion
Taxane: Investigator's choice of docetaxel or paclitaxel administered by intravenous infusion
Pertuzumab: Administered by intravenous infusion
Trastuzumab: Administered by intravenous infusion
Study 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 growth factor receptor 2 (HER2)-positive breast cancer as a first line of treatment in the metastatic setting.
Eligibility
Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Key Inclusion Criteria:
* Patients must be ≥18 years of age
* Pathologically documented breast cancer that:
1. is advanced or metastatic
2. is locally assessed and prospectively centrally confirmed as HER2-positive (IHC3+ or ISH+)
3. 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 Criteria:
* 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
Primary outcome measure(s)
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment — Until progression or death, assessed up to approximately 60 months Defined as time from date of randomisation until the date of objective radiological disease progression according to Blinded Independent Central Review (BICR) using RECIST 1.1 or death by any cause.
Trial sites (283)
Facility
City
Region
Status
Research Site
Tucson
Arizona
Research Site
Springdale
Arkansas
Research Site
Glendale
California
Research Site
Glendale
California
Research Site
Longmont
Colorado
Research Site
Miami
Florida
Research Site
Palm Bay
Florida
Research Site
Plantation
Florida
Research Site
Atlanta
Georgia
Research Site
Louisville
Kentucky
Research Site
Silver Spring
Maryland
Research Site
Boston
Massachusetts
Research Site
Detroit
Michigan
Research Site
Jackson
Mississippi
Research Site
Las Vegas
Nevada
Research Site
Summit
New Jersey
Research Site
New York
New York
Research Site
Shirley
New York
Research Site
York
Pennsylvania
Research Site
Germantown
Tennessee
Research Site
Dallas
Texas
Research Site
Dallas
Texas
Research Site
Denton
Texas
Research Site
Houston
Texas
Research Site
San Antonio
Texas
Research Site
Shenandoah
Texas
Research Site
Tyler
Texas
Research Site
Norfolk
Virginia
Research Site
Roanoke
Virginia
Research Site
Tacoma
Washington
Research Site
Buenos Aires
Argentina
Research Site
CABA
Argentina
Research Site
CABA
Argentina
Research Site
Caba
Argentina
Research Site
Capital Federal
Argentina
Research Site
Cipolletti
Argentina
Research Site
Ciudad de Buenos Aires
Argentina
Research Site
La Plata
Argentina
Research Site
Mar del Plata
Argentina
Research Site
Rosario
Argentina
+ 243 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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