A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)
Megadott ok: 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 és Whittier, Egyesült ÁllamokSee the 36 sites
- Phase
- 2. fázis
Where in Egyesült Államok
- Alaska Urological Institute dba Alaska Clinical Research CenterAnchorage, Egyesült ÁllamokNo longer taking part
- Piedmont Cancer InstituteAtlanta, Egyesült ÁllamokNo longer taking part
- Accurate Clinical ResearchBaytown, Egyesült ÁllamokNo longer taking part
- Sylvester Comprehensive Cancer Center - Deerfield BeachBoca Raton, Egyesült ÁllamokNo longer taking part
- Beth Israel Deaconess Medical CenterBoston, Egyesült ÁllamokNo longer taking part
- Dana-Farber Cancer InstituteBoston, Egyesült ÁllamokNo longer taking part
- Aultman Hospital Cancer CenterCanton, Egyesült ÁllamokNo longer taking part
- University of Cincinnati Medical CenterCincinnati, Egyesült ÁllamokNo longer taking part
- Texas Oncology, P.A.Dallas, Egyesült ÁllamokNo longer taking part
- Henry Ford HospitalDetroit, Egyesült ÁllamokNo longer taking part
- North Shore Hematology Oncology Associates PC DBA NY Cancer and Blood SpecialistsEast Setauket, Egyesült ÁllamokNo longer taking part
- Providence Regional Medical Center EverettEverett, Egyesült ÁllamokNo longer taking part
- Virginia Cancer Specialists PCFairfax, Egyesült ÁllamokNo longer taking part
- St Francis HospitalGreenville, Egyesült ÁllamokNo longer taking part
- Specialist Global ResearchHialeah, Egyesült ÁllamokNo longer taking part
- Straub Medical CenterHonolulu, Egyesült ÁllamokNo longer taking part
- University of HawaiiHonolulu, Egyesült ÁllamokNo longer taking part
- MD Anderson Cancer CenterHouston, Egyesült ÁllamokNo longer taking part
- Texas Oncology - Memorial CityHouston, Egyesült ÁllamokNo longer taking part
- The Methodist Hospital Research InstituteHouston, Egyesült ÁllamokNo longer taking part
- The Regents of the University of CaliforniaLos Angeles, Egyesült ÁllamokNo longer taking part
- Norton HealthcareLouisville, Egyesült ÁllamokNo longer taking part
- University of Louisville Research FoundationLouisville, Egyesült ÁllamokNo longer taking part
- Miami Cancer Institute at Baptist Health, Inc.Miami, Egyesült ÁllamokNo longer taking part
- Ochsner Clinic FoundationNew Orleans, Egyesült ÁllamokNo longer taking part
- Memorial Sloan-Kettering Cancer CenterNew York, Egyesült ÁllamokNo longer taking part
- Allegheny General HospitalPittsburgh, Egyesült ÁllamokNo longer taking part
- UPMC Cancer CenterPittsburgh, Egyesült ÁllamokNo longer taking part
- Sharp Clinical Oncology ResearchSan Diego, Egyesült ÁllamokNo longer taking part
- University of California San FranciscoSan Francisco, Egyesült ÁllamokNo longer taking part
- Sansum ClinicSanta Barbara, Egyesült ÁllamokNo longer taking part
- Washington University School of MedicineSt Louis, Egyesült ÁllamokNo longer taking part
- Arizona Oncology AssociatesTucson, Egyesült ÁllamokNo longer taking part
- Texas Oncology, P.A. - LongviewTyler, Egyesült ÁllamokNo longer taking part
- The University of Texas Health Science Center at TylerTyler, Egyesült ÁllamokNo longer taking part
- Innovative Clinical Research Institute, LLCWhittier, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Daiichi Sankyo
- Trial code
- NCT03248492
- Record updated
- 2025. június 26.
- 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.