Clinical Trial

HER2-Low Breast Cancer

Study Description

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

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

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

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)

Additional Information

Official Study Title

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

Clinical Trial ID

NCT03734029

ParticipAid ID

en5Yld