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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 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1157

Last updated 2026-05-22

No results posted yet for this 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.

Conditions

  • Breast Cancer; HER2-positive; Metastatic

Interventions

DRUG

Trastuzumab deruxtecan

Administered by intravenous infusion

DRUG

Placebo

Administered by intravenous infusion

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-26
Primary Completion
2026-07-06
Completion
2029-12-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Canada
  • China
  • Denmark
  • France
  • Germany
  • Hungary
  • India
  • Israel
  • Italy
  • Japan
  • Mexico
  • Peru
  • Philippines
  • Romania
  • Russia
  • Saudi Arabia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04784715 on ClinicalTrials.gov