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

Conditions

• Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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

Key Dates

Start date

Dec 27, 2018

Status verified

Sep 2025

Primary completion

Jan 11, 2022

Completion

Aug 1, 2026

Study Design

Enrollment

557 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Trastuzumab deruxtecan
  HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to DS8201a
• Active Comparator: Physician's Choice
  HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to Physician's choice from the following options: * Capecitabine * Eribulin * Gemcitabine * Paclitaxel * Nab-paclitaxel

Primary Outcome Measure

Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer [ Time Frame: From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years ]

Locations (38)

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