A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)
Reason given: The last participant was transitioned to alternative study.
Key facts
- Where
- Anchorage, Atlanta, Baytown, Boca Raton, Boston, Canton, Cincinnati, Dallas, Detroit, East Setauket, Everett, Fairfax, Greenville, Hialeah, Honolulu, Houston, Los Angeles, Louisville, Miami, New Orleans, New York, Pittsburgh, San Diego, San Francisco, Santa Barbara, St Louis, Tucson, Tyler, and Whittier, United StatesSee the 36 sites
- Phase
- Phase 2
Where in United States
- Alaska Urological Institute dba Alaska Clinical Research CenterAnchorage, United StatesNo longer taking part
- Piedmont Cancer InstituteAtlanta, United StatesNo longer taking part
- Accurate Clinical ResearchBaytown, United StatesNo longer taking part
- Sylvester Comprehensive Cancer Center - Deerfield BeachBoca Raton, United StatesNo longer taking part
- Beth Israel Deaconess Medical CenterBoston, United StatesNo longer taking part
- Dana-Farber Cancer InstituteBoston, United StatesNo longer taking part
- Aultman Hospital Cancer CenterCanton, United StatesNo longer taking part
- University of Cincinnati Medical CenterCincinnati, United StatesNo longer taking part
- Texas Oncology, P.A.Dallas, United StatesNo longer taking part
- Henry Ford HospitalDetroit, United StatesNo longer taking part
- North Shore Hematology Oncology Associates PC DBA NY Cancer and Blood SpecialistsEast Setauket, United StatesNo longer taking part
- Providence Regional Medical Center EverettEverett, United StatesNo longer taking part
- Virginia Cancer Specialists PCFairfax, United StatesNo longer taking part
- St Francis HospitalGreenville, United StatesNo longer taking part
- Specialist Global ResearchHialeah, United StatesNo longer taking part
- Straub Medical CenterHonolulu, United StatesNo longer taking part
- University of HawaiiHonolulu, United StatesNo longer taking part
- MD Anderson Cancer CenterHouston, United StatesNo longer taking part
- Texas Oncology - Memorial CityHouston, United StatesNo longer taking part
- The Methodist Hospital Research InstituteHouston, United StatesNo longer taking part
- The Regents of the University of CaliforniaLos Angeles, United StatesNo longer taking part
- Norton HealthcareLouisville, United StatesNo longer taking part
- University of Louisville Research FoundationLouisville, United StatesNo longer taking part
- Miami Cancer Institute at Baptist Health, Inc.Miami, United StatesNo longer taking part
- Ochsner Clinic FoundationNew Orleans, United StatesNo longer taking part
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesNo longer taking part
- Allegheny General HospitalPittsburgh, United StatesNo longer taking part
- UPMC Cancer CenterPittsburgh, United StatesNo longer taking part
- Sharp Clinical Oncology ResearchSan Diego, United StatesNo longer taking part
- University of California San FranciscoSan Francisco, United StatesNo longer taking part
- Sansum ClinicSanta Barbara, United StatesNo longer taking part
- Washington University School of MedicineSt Louis, United StatesNo longer taking part
- Arizona Oncology AssociatesTucson, United StatesNo longer taking part
- Texas Oncology, P.A. - LongviewTyler, United StatesNo longer taking part
- The University of Texas Health Science Center at TylerTyler, United StatesNo longer taking part
- Innovative Clinical Research Institute, LLCWhittier, United StatesNo longer taking part
Trial details
- Who runs it
- Daiichi Sankyo
- Trial code
- NCT03248492
- Record updated
- 26 June 2025
- Original description
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.Read full original descriptionShow less
A Phase 2, Multicenter, Open-Label Study of DS-8201a, an Anti-HER2-Antibody Drug Conjugate (ADC) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1 (DESTINY-Breast01)
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.
Inclusion: 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.
Exclusion: Has a medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia; 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; Has a corrected QT interval (QTc) prolongation to > 450 millisecond (ms) in males and > 470 ms in females.