Breast Cancer Clinical Trial
A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)
Summary
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.
Eligibility Criteria
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
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There are 95 Locations for this study
Anchorage Alaska, 99508, United States
Tucson Arizona, 85704, United States
Los Angeles California, 90095, United States
San Diego California, 92123, United States
San Francisco California, 94115, United States
Santa Barbara California, 93105, United States
Whittier California, 90603, United States
Boca Raton Florida, 33426, United States
Hialeah Florida, 33012, United States
Miami Florida, 33176, United States
Atlanta Georgia, 30318, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Louisville Kentucky, 40202, United States
Louisville Kentucky, 40202, United States
New Orleans Louisiana, 70120, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48202, United States
Saint Louis Missouri, 63110, United States
East Setauket New York, 11733, United States
New York New York, 10065, United States
Canton Ohio, 44710, United States
Cincinnati Ohio, 45267, United States
Pittsburgh Pennsylvania, 15212, United States
Pittsburgh Pennsylvania, 15232, United States
Greenville South Carolina, 29601, United States
Baytown Texas, 77521, United States
Dallas Texas, 75246, United States
Houston Texas, 77024, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Tyler Texas, 75702, United States
Tyler Texas, 75708, United States
Fairfax Virginia, 22031, United States
Everett Washington, 98201, United States
Bonheiden , 2820, Belgium
Charleroi , 6000, Belgium
Leuven , 3000, Belgium
Liège , 4000, Belgium
Mechelen , 2800, Belgium
Calgary Alberta, T2N 4, Canada
Avignon , 84918, France
Besançon , 25030, France
Dijon , 21079, France
Gironde , 33075, France
La Rochelle , 17019, France
Le Mans , 72015, France
Marseille , 13915, France
Montpellier , 34298, France
Nantes , 44202, France
Paris , 75475, France
Pierre-Bénite , 69495, France
Rennes , 35042, France
Saint-Mandé , 94160, France
Strasbourg , 67000, France
Villejuif , 94805, France
Milano , 20132, Italy
Milano , 20133, Italy
Milano , 20141, Italy
Monza , 20900, Italy
Rimini , 47923, Italy
Torrette , 60020, Italy
Matsuyama Ehime-Ken, 791-0, Japan
Minato-Ku Tokyo-To, 105-8, Japan
Aichi , 464-8, Japan
Chiba , 277-8, Japan
Fukuoka , 811-1, Japan
Kagoshima , 892-0, Japan
Kanagawa , 241-0, Japan
Osaka , 589-8, Japan
Tokyo , 104-0, Japan
Tokyo , 104-8, Japan
Tokyo , 135-8, Japan
Daegu , 41404, Korea, Republic of
Goyang-si , 10408, Korea, Republic of
Seongnam-si , 13620, Korea, Republic of
Seoul , 02841, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Badajoz , 6080, Spain
Barcelona , 08028, Spain
Barcelona , 08035, Spain
Barcelona , 08908, Spain
Barcelona , 8023, Spain
Madrid , 28033, Spain
Madrid , 28034, Spain
Madrid , 28046, Spain
Málaga , 29010, Spain
Sevilla , 41009, Spain
Valencia , 46009, Spain
Plymouth Devon, PL6 8, United Kingdom
London Greater London, EC1M , United Kingdom
London Greater London, NW1 2, United Kingdom
Edinburgh Lothian Region, EH4 2, United Kingdom
Nottingham Nottinghamshire, NG5 1, United Kingdom
Guildford Surrey, GU2 7, United Kingdom
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