A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring HER-2 positive breast cancer, Metastatic or Unresectable, Resistant or refractory to T-DM1, DESTINY - Breast 01, Trastuzumab deruxtecan, T-DXd
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
Sites / Locations
- Alaska Urological Institute dba Alaska Clinical Research Center
- Arizona Oncology Associates
- The Regents of the University of California
- Sharp Clinical Oncology Research
- University of California San Francisco
- Sansum Clinic
- Innovative Clinical Research Institute, LLC
- Sylvester Comprehensive Cancer Center - Deerfield Beach
- Specialist Global Research
- Miami Cancer Institute at Baptist Health, Inc.
- Piedmont Cancer Institute
- Straub Medical Center
- University of Hawaii
- Norton Healthcare
- University of Louisville Research Foundation
- Ochsner Clinic Foundation
- Beth Israel Deaconess Medical Center
- Dana Farber Cancer Institute
- Henry Ford Hospital
- Washington University School of Medicine
- North Shore Hematology Oncology Associates PC DBA NY Cancer and Blood Specialists
- Memorial Sloan Kettering Cancer Center
- Aultman Hospital Cancer Center
- University of Cincinnati Medical Center
- Allegheny General Hospital
- UPMC Cancer Center
- St Francis Hospital
- Accurate Clinical Research
- Texas Oncology, P.A.
- Texas Oncology - Memorial City
- MD Anderson Cancer Center
- The Methodist Hospital Research Institute
- Texas Oncology, P.A. - Longview
- The University of Texas Health Science Center at Tyler
- Virginia Cancer Specialists, PC
- Providence Regional Medical Center - Everett
- Imeldaziekenhuis
- Grand Hôpital de Charleroi
- UZ Leuven
- CHU Sart Tilman
- AZ Sint-Maarten
- University of Calgary
- Institut Sainte Catherine
- CHU Besançon - Hôpital Jean Minjoz
- Centre Georges François Leclerc
- CHU Bordeaux - Hôpital Saint André
- CH de la Rochelle - Hopital St Louis
- Clinique Victor Hugo - Centre Jean Bernard
- Hôpital Nord - CHU Marseille
- Institut Régional du Cancer de Montpellier
- Centre Catherine de Sienne
- Hôpital Saint-Louis - Paris
- Centre Hospitalier Lyon Sud
- CRLCC Eugene Marquis
- Hôpital d'Instruction des Armees Begin
- Centre Paul Strauss
- Institut Gustave Roussy
- Ospedale San Raffaele
- Fondazione IRCCS Istituto Nazionale dei Tumori
- IEO Istituto Europeo di Oncologia
- Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
- Ospedale degli Infermi
- Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
- NHO Shikoku Cancer Center
- Toranomon Hospital
- Aichi Cancer Center Hospital
- National Cancer Center Hospital East
- NHO Kyushu Cancer Center
- Hakuaikai Sagara Hospital
- Kanagawa Cancer Center
- Kindai University Hospital
- National Cancer Center Hospital
- St. Luke's International Hospital
- Cancer Institute Hospital of JFCR
- Kyungpook National University Chilgok Hospital
- National Cancer Center
- Seoul National University Bundang Hospital
- Korea University Anam Hospital
- Seoul National University Hospital
- Severance Hospital, Yonsei University
- Asan Medical Center
- Samsung Medical Center
- Hospital Infanta Cristina
- Hospital Universitari Quiron Dexeus
- Hospital Universitari Vall d'Hebron
- ICO l´Hospitalet - Hospital Duran i Reynals
- Hospital Quiron Barcelona
- MD Anderson Cancer Centre
- Hospital Universitario Ramon y Cajal
- Hospital Universitario La Paz
- Hospital Clinico Universitario Virgen de la Victoria
- Hospital Universitario Virgen Macarena
- Instituto Valenciano de Oncologia IVO
- Derriford Hospital
- Queen Mary University of London
- University College London Hospitals
- Western General Hospital
- Nottingham University Hospitals City Campus
- Royal Surrey County Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Other
DS-8201a Low Dose
DS-8201a Medium Dose
DS-8201a High Dose
Exploratory Arm
T-DM1 resistant/refractory (R/R) patients in the low dose treatment group
T-DM1 resistant/refractory (R/R) patients in the medium dose treatment group
T-DM1 resistant/refractory (R/R) patients in the high dose treatment group
In Part 2b- Continuation Stage, about 10 T-DM1 Intolerant patients will receive the DS-8201a recommended dose (RD) as an exploratory arm