NCT03734029

Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 557 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before. Participants' cancer: * Cannot be removed by an operation * Has spread to other parts of the body

Detailed description

This is a randomized, 2-arm, Phase 3, open-label, multicenter study to compare the safety and efficacy of trastuzumab deruxtecan versus the physician's choice (2:1) in HER2-low, unresectable and/or metastatic breast cancer participants. The Sponsor proposes to define a new HER2-low population in this trial including tumors with IHC 1+ and IHC 2+/ISH- HER2 expression.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab deruxtecan (DS-8201a)	DS-8201a is a lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered intravenously
DRUG	Capecitabine	Administered according to label, as one option for Physician's Choice (determined before randomization)
DRUG	Eribulin	Administered according to label, as one option for Physician's Choice (determined before randomization)
DRUG	Gemcitabine	Administered according to label, as one option for Physician's Choice (determined before randomization)
DRUG	Paclitaxel	Administered according to label, as one option for Physician's Choice (determined before randomization)
DRUG	Nab-paclitaxel	Administered according to label, as one option for Physician's Choice (determined before randomization)

Timeline

• Start date: 2018-12-27
• Primary completion: 2022-01-11
• Completion: 2026-08-01
• First posted: 2018-11-07
• Last updated: 2025-10-06
• Results posted: 2023-06-15

Locations

208 sites across 20 countries: United States, Austria, Belgium, Canada, China, France, Germany, Greece, Hungary, Israel, Italy, Japan, Portugal, Russia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study