A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)

Stopped early · Phase 2

Conditions studied: Breast Cancer

In brief

Some human epidermal growth factor receptor 2 (HER-2) breast cancer patients do not respond or become resistant to current treatment. DS-8201a is a new experimental product that is a combination of an antibody and a drug. It has not yet been approved for use. DS-8201a may slow down tumor growth. This might improve outcomes for these patients.

Key facts

Study ID

NCT03248492

Run by

Daiichi Sankyo

People needed

253

Starts

2017-08-25

Expected to finish

2024-05-06

Last updated by the study team

2025-06-26

Who can join

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

You may qualify if…

• Men or women the age of majority in their country
• Has pathologically documented breast cancer that:
• is unresectable or metastatic
• has HER2 positive expression confirmed per protocol
• Has an adequate tumor sample
• Has at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
• Has protocol-defined adequate cardiac, renal and hepatic function
• Agrees to follow protocol-defined method(s) of contraception

You may not qualify if…

• Has a medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia
• Has a corrected QT interval (QTc) prolongation to > 450 millisecond (ms) in males and > 470 ms in females
• Has a medical history of clinically significant lung disease
• Is suspected to have certain other protocol-defined diseases based on imaging at screening period
• Has history of any disease, metastatic condition, drug/medication use or other condition that might, per protocol or in the opinion of the investigator, compromise:
• safety or well-being of the participant or offspring
• safety of study staff
• analysis of results

Where it is running

• Arizona Oncology Associates — Tucson, Arizona, United States
• The Regents of the University of California — Los Angeles, California, United States
• Sharp Clinical Oncology Research — San Diego, California, United States
• University of California San Francisco — San Francisco, California, United States
• Sansum Clinic — Santa Barbara, California, United States
• Innovative Clinical Research Institute, LLC — Whittier, California, United States
• Sylvester Comprehensive Cancer Center - Deerfield Beach — Boca Raton, Florida, United States
• Specialist Global Research — Hialeah, Florida, United States
• Miami Cancer Institute at Baptist Health, Inc. — Miami, Florida, United States
• Piedmont Cancer Institute — Atlanta, Georgia, United States
• Straub Medical Center — Honolulu, Hawaii, United States
• University of Hawaii — Honolulu, Hawaii, United States
• Norton Healthcare — Louisville, Kentucky, United States
• University of Louisville Research Foundation — Louisville, Kentucky, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, 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
• Washington University School of Medicine — St Louis, Missouri, United States
• North Shore Hematology Oncology Associates PC DBA NY Cancer and Blood Specialists — East Setauket, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Aultman Hospital Cancer Center — Canton, Ohio, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• Alaska Urological Institute dba Alaska Clinical Research Center — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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