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

NCT04784715

Active Not RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Breast Cancer; HER2-positive; Metastatic

Interventions: Trastuzumab deruxtecan, Placebo, Taxane, Pertuzumab, Trastuzumab

Countries: United States, Argentina, Belgium, Brazil, Canada, China, Denmark, France

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 overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (283)

Tucson, Arizona, United States
Springdale, Arkansas, United States
Glendale, California, United States
Glendale, California, United States
Longmont, Colorado, United States
Miami, Florida, United States
Palm Bay, Florida, United States
Plantation, Florida, United States
Atlanta, Georgia, United States
Louisville, Kentucky, United States
Silver Spring, Maryland, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Jackson, Mississippi, United States
Las Vegas, Nevada, United States
Summit, New Jersey, United States
New York, New York, United States
Shirley, New York, United States
York, Pennsylvania, United States
Germantown, Tennessee, United States
Dallas, Texas, United States
Dallas, Texas, United States
Denton, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Shenandoah, Texas, United States
Tyler, Texas, United States
Norfolk, Virginia, United States
Roanoke, Virginia, United States
Tacoma, Washington, United States
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