A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)
Trial Status: Closed to Accrual
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 Criteria
- 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 Criteria
- 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
California
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Dorreth King-Rucker
Phone: 310-794-5782
Email:
dkingrucker@mednet.ucla.edu
San Francisco
UCSF Medical Center-Mount Zion
Status: CLOSED_TO_ACCRUAL
Contact: UCSF Clinical Trials
Phone: 877-827-3222
Email:
cancertrials@ucsf.edu
Hawaii
Honolulu
Kapiolani Medical Center for Women and Children
Status: CLOSED_TO_ACCRUAL
Straub Clinic and Hospital
Status: CLOSED_TO_ACCRUAL
Massachusetts
Boston
Beth Israel Deaconess Medical Center
Status: ACTIVE
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE
Missouri
Saint Louis
Siteman Cancer Center at Washington University
Status: CLOSED_TO_ACCRUAL
New York
New York
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Shanu Modi
Phone: 646-888-4564
Email:
modis@mskcc.org
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: CLOSED_TO_ACCRUAL
Texas
Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: IN_REVIEW
Contact: James Gregory Wright
Phone: 214-648-7020
Houston
M D Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL
Trial Phase Phase II
Trial Type Treatment
Lead Organization
Daiichi Sankyo Inc
- Primary ID DS8201-A-U201
- Secondary IDs NCI-2017-02077, 2016-004986-18, DESTINY-B01, DESTINY-Breast01, JapicCTI-173693(en)
- Clinicaltrials.gov ID NCT03248492