DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]

Completed · Phase 3

Conditions studied: Breast Cancer

In brief

This study will compare DS 8201a to standard treatment. Participants must have HER2 breast cancer that has been treated before. Their cancer: * cannot be removed by an operation * has spread to other parts of the body

Key facts

Study ID

NCT03523585

Run by

Daiichi Sankyo

People needed

608

Starts

2018-08-01

Expected to finish

2025-12-23

Last updated by the study team

2026-02-27

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 confirmed HER2-positive expression as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory
• was previously treated with ado-trastuzumab emtansine (T-DM1)
• Has documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy)
• Is HER2 positive as confirmed by central laboratory assessment of most recent tumor tissue sample available. If archived tissue is not available, agrees to provide a fresh biopsy.
• Male and female participants of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least:
• 7 months after the last dose of DS-8201a (females); 4.5 months after last dose of DS-8201a (males)
• 6 months after the last dose of lapatinib/capecitabine for female participants (3 months for male participants)
• 7 months after the last dose of trastuzumab/capecitabine
• Has adequate hematopoietic, renal and hepatic functions

You may not qualify if…

• Has previously participated in an antibody drug conjugate study sponsored by Daiichi Sankyo. Prior treatment in the adjuvant/neo-adjuvant setting would be allowed if progression of disease did not occur within 12 months of end of adjuvant therapy
• Has had prior treatment with capecitabine
• Has uncontrolled or significant cardiovascular disease
• Has a 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 active central nervous system (CNS) metastases

Where it is running

• UCLA Hematology Oncology - Main Site — Los Angeles, California, United States
• Pacific Cancer Care — Monterey, California, United States
• Sharp Memorial Hospital — San Diego, California, United States
• Innovative Clinical Research Institute — Whittier, California, United States
• Smilow Cancer Hospital at Yale New Haven — New Haven, Connecticut, United States
• Washington Cancer Institute — Washington D.C., District of Columbia, United States
• Florida Cancer Specialists-Broadway — Fort Myers, Florida, United States
• Piedmont Cancer Institute, PC — Atlanta, Georgia, United States
• Kapiolani Medical Center for Women and Children/Univ of HI — Honolulu, Hawaii, United States
• Loyola University Health System — Maywood, Illinois, United States
• Community Hospital — Munster, Indiana, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Maine Center for Cancer Medicine — Scarborough, Maine, United States
• University of Maryland — Baltimore, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Cornell-Beshore Cancer Institute — Joplin, Missouri, United States
• Saint Luke's Cancer Institute — Kansas City, Missouri, United States
• Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC — Kansas City, Missouri, United States
• Washington University — St Louis, Missouri, United States
• North Shore Hematology Oncology Associates, PC — East Setauket, New York, United States
• Memorial Sloan-Kettering Cancer Center (MSKCC) - New York — New York, New York, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• Ironwood Cancer Research Centers — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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