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Clinical Trials in India / NCT04784715
Active, not recruiting Phase 3

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

NCT04784715 · tracked via the Priya Life Science India tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2021-04-26
Last updated
2026-07-30

Condition(s) studied

Breast Cancer; HER2-positive; Metastatic

Investigational drug(s) / intervention(s)

Trastuzumab deruxtecanPlaceboTaxanePertuzumabTrastuzumab

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)

Trial sites (283)

FacilityCityRegionStatus
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.

Official registry record

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.

View NCT04784715 on ClinicalTrials.gov ↗ ← All trials in India