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

Running, not enrolling · Phase 3

Conditions studied: Breast Cancer

In brief

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 facts

Study ID

NCT03734029

Run by

Daiichi Sankyo

People needed

557

Starts

2018-12-27

Expected to finish

2026-08-01

Last updated by the study team

2025-10-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is the age of majority in their country
• Has pathologically documented breast cancer that:
• Is unresectable or metastatic
• Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested)
• Is HR-positive or HR-negative
• Has progressed on, and would no longer benefit from, endocrine therapy
• Has been treated with 1 to 2 prior lines of chemotherapy/adjuvant in the recurrent or metastatic setting
• Was never previously HER2-positive (ICH 3+ or ISH+) on prior pathology testing (per American Society of Clinical Oncology-College of American Pathologists [ASCO-CAP] guidelines)
• Has documented radiologic progression (during or after most recent treatment)
• Has adequate archival tumor samples available or is wiling to provide fresh biopsies prior to randomization for:
• assessment of HER2 status
• assessment of post-treatment status
• Has at least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors 1.1
• Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions
• Male and female participants of reproductive/childbearing potential, agrees to follow instructions for method(s) of contraception and agrees to avoid preserving ova or sperm for at least 4.5 months after treatment (or longer, per locally approved labels)

You may not qualify if…

• Is ineligible for all options in the physician's choice arm
• Has breast cancer ever assessed with high-HER2 expression
• Has previously been treated with any anti-HER2 therapy, including an antibody drug conjugate
• Has uncontrolled or significant cardiovascular disease
• Has spinal cord compression or clinically active central nervous system metastases
• Has history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
• Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study

Where it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• Cancer Treatment Centers of America at Western Regional Medical Center — Goodyear, Arizona, United States
• UCLA School of Medicine — Los Angeles, California, United States
• Stanford Cancer Institute — Palo Alto, California, United States
• Cancer Care Associates Medical Group, Inc. TORI — Redondo Beach, California, United States
• University of California at San Francisco (PARENT) — San Francisco, California, United States
• Eastern Connecticut Hematology/Oncology Assoc. — Norwich, Connecticut, United States
• Christiana Care Health Services, Inc. — Newark, Delaware, United States
• Sylvester Comprehensive Cancer Center - Deerfield Beach — Boca Raton, Florida, United States
• Florida Cancer Specialists (South Region) — Fort Myers, Florida, United States
• Memorial Healthcare System MRH Cancer Center — Hollywood, Florida, United States
• Orlando Health, Inc. — Orlando, Florida, United States
• Moffitt Cancer Center -Tampa — Tampa, Florida, United States
• Cancer Treatment Centers of America-Georgia — Newnan, Georgia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Cancer Treatment Centers of America — Zion, Illinois, United States
• Cancer Center of Kansas — Wichita, Kansas, United States
• Touro Infirmary — New Orleans, Louisiana, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States
• Saint Barnabas Medical Center — Livingston, New Jersey, United States
• New York University Medical Center — New York, New York, United States
• Memorial Sloan Kettering Hospital — New York, New York, United States
• Ironwood Cancer & Research Centers - Chandler II — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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