A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)
NCT ID: NCT03248492
Last Updated: 2025-06-26
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
253 participants
INTERVENTIONAL
2017-08-25
2024-05-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DS-8201a Low Dose
T-DM1 resistant/refractory (R/R) patients in the low dose treatment group
DS-8201a
DS-8201a is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered as low, medium and high intravenous (IV) doses for Part 1 of the trial. The dose for Part 2 will be determined based on results from Part 1.
DS-8201a Medium Dose
T-DM1 resistant/refractory (R/R) patients in the medium dose treatment group
DS-8201a
DS-8201a is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered as low, medium and high intravenous (IV) doses for Part 1 of the trial. The dose for Part 2 will be determined based on results from Part 1.
DS-8201a High Dose
T-DM1 resistant/refractory (R/R) patients in the high dose treatment group
DS-8201a
DS-8201a is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered as low, medium and high intravenous (IV) doses for Part 1 of the trial. The dose for Part 2 will be determined based on results from Part 1.
Exploratory Arm
In Part 2b- Continuation Stage, about 10 T-DM1 Intolerant patients will receive the DS-8201a recommended dose (RD) as an exploratory arm
DS-8201a
DS-8201a is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered as low, medium and high intravenous (IV) doses for Part 1 of the trial. The dose for Part 2 will be determined based on results from Part 1.
Interventions
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DS-8201a
DS-8201a is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered as low, medium and high intravenous (IV) doses for Part 1 of the trial. The dose for Part 2 will be determined based on results from Part 1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has pathologically documented breast cancer that:
1. is unresectable or metastatic
2. 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 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:
1. safety or well-being of the participant or offspring
2. safety of study staff
3. analysis of results
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Daiichi Sankyo Co., Ltd.
INDUSTRY
Daiichi Sankyo
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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Texas Oncology, P.A. - Longview
Tyler, Texas, United States
Alaska Urological Institute dba Alaska Clinical Research Center
Anchorage, Alaska, United States
Arizona Oncology Associates
Tucson, Arizona, United States
The Regents of the University of California
Los Angeles, California, United States
Sharp Clinical Oncology Research
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
Sansum Clinic
Santa Barbara, California, United States
Innovative Clinical Research Institute, LLC
Whittier, California, United States
Sylvester Comprehensive Cancer Center - Deerfield Beach
Boca Raton, Florida, United States
Specialist Global Research
Hialeah, Florida, United States
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States
Piedmont Cancer Institute
Atlanta, Georgia, United States
Straub Medical Center
Honolulu, Hawaii, United States
University of Hawaii
Honolulu, Hawaii, United States
Norton Healthcare
Louisville, Kentucky, United States
University of Louisville Research Foundation
Louisville, Kentucky, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
North Shore Hematology Oncology Associates PC DBA NY Cancer and Blood Specialists
East Setauket, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Aultman Hospital Cancer Center
Canton, Ohio, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
UPMC Cancer Center
Pittsburgh, Pennsylvania, United States
St Francis Hospital
Greenville, South Carolina, United States
Accurate Clinical Research
Baytown, Texas, United States
Texas Oncology, P.A.
Dallas, Texas, United States
Texas Oncology - Memorial City
Houston, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
The Methodist Hospital Research Institute
Houston, Texas, United States
The University of Texas Health Science Center at Tyler
Tyler, Texas, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Providence Regional Medical Center - Everett
Everett, Washington, United States
Imeldaziekenhuis
Bonheiden, , Belgium
Grand Hôpital de Charleroi
Charleroi, , Belgium
UZ Leuven
Leuven, , Belgium
CHU Sart Tilman
Liège, , Belgium
AZ Sint-Maarten
Mechelen, , Belgium
University of Calgary
Calgary, Alberta, Canada
Institut Sainte Catherine
Avignon, , France
CHU Besançon - Hôpital Jean Minjoz
Besançon, , France
Centre Georges François Leclerc
Dijon, , France
CHU Bordeaux - Hôpital Saint André
Gironde, , France
CH de la Rochelle - Hopital St Louis
La Rochelle, , France
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, , France
Hôpital Nord - CHU Marseille
Marseille, , France
Institut Régional du Cancer de Montpellier
Montpellier, , France
Centre Catherine de Sienne
Nantes, , France
Hôpital Saint-Louis - Paris
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CRLCC Eugene Marquis
Rennes, , France
Hôpital d'Instruction des Armees Begin
Saint-Mandé, , France
Centre Paul Strauss
Strasbourg, , France
Institut Gustave Roussy
Villejuif, , France
Ospedale San Raffaele
Milan, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
IEO Istituto Europeo di Oncologia
Milan, , Italy
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
Monza, , Italy
Ospedale degli Infermi
Rimini, , Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Torrette, , Italy
NHO Shikoku Cancer Center
Matsuyama, Ehime, Japan
Toranomon Hospital
Minatoku, Tokyo-To, Japan
Aichi Cancer Center Hospital
Aichi, , Japan
National Cancer Center Hospital East
Chiba, , Japan
NHO Kyushu Cancer Center
Fukuoka, , Japan
Hakuaikai Sagara Hospital
Kagoshima, , Japan
Kanagawa Cancer Center
Kanagawa, , Japan
Kindai University Hospital
Osaka, , Japan
National Cancer Center Hospital
Tokyo, , Japan
St. Luke's International Hospital
Tokyo, , Japan
Cancer Institute Hospital of JFCR
Tokyo, , Japan
Kyungpook National University Chilgok Hospital
Daegu, , South Korea
National Cancer Center
Goyang-si, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Infanta Cristina
Badajoz, , Spain
Hospital Universitari Quiron Dexeus
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
ICO l´Hospitalet - Hospital Duran i Reynals
Barcelona, , Spain
Hospital Quiron Barcelona
Barcelona, , Spain
MD Anderson Cancer Centre
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Instituto Valenciano de Oncologia IVO
Valencia, , Spain
Derriford Hospital
Plymouth, Devon, United Kingdom
Queen Mary University of London
London, Greater London, United Kingdom
University College London Hospitals
London, Greater London, United Kingdom
Western General Hospital
Edinburgh, Lothian Region, United Kingdom
Nottingham University Hospitals City Campus
Nottingham, Nottinghamshire, United Kingdom
Royal Surrey County Hospital
Guildford, Surrey, United Kingdom
Countries
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References
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Dunton K, Vondeling G, Hancock E, Petrou M, Burn O, Paine A. Methods for Estimating Long-Term Outcomes for Trastuzumab Deruxtecan in HER2-Positive Unresectable or Metastatic Breast Cancer After Two or More Anti-HER2 Therapies. Target Oncol. 2022 Nov;17(6):655-663. doi: 10.1007/s11523-022-00923-9. Epub 2022 Nov 7.
Rugo HS, Bianchini G, Cortes J, Henning JW, Untch M. Optimizing treatment management of trastuzumab deruxtecan in clinical practice of breast cancer. ESMO Open. 2022 Aug;7(4):100553. doi: 10.1016/j.esmoop.2022.100553. Epub 2022 Aug 11.
Bardia A, Harnden K, Mauro L, Pennisi A, Armitage M, Soliman H. Clinical Practices and Institutional Protocols on Prophylaxis, Monitoring, and Management of Selected Adverse Events Associated with Trastuzumab Deruxtecan. Oncologist. 2022 Aug 5;27(8):637-645. doi: 10.1093/oncolo/oyac107.
Modi S. Trastuzumab deruxtecan in previously treated HER2-positive metastatic breast cancer: Plain language summary of the DESTINY-Breast01 study. Future Oncol. 2021 Sep 1;17(26):3415-3423. doi: 10.2217/fon-2021-0427. Epub 2021 Jul 15.
Yin O, Iwata H, Lin CC, Tamura K, Watanabe J, Wada R, Kastrissios H, AbuTarif M, Garimella T, Lee C, Zhang L, Shahidi J, LaCreta F. Exposure-Response Relationships in Patients With HER2-Positive Metastatic Breast Cancer and Other Solid Tumors Treated With Trastuzumab Deruxtecan. Clin Pharmacol Ther. 2021 Oct;110(4):986-996. doi: 10.1002/cpt.2291. Epub 2021 Jun 10.
Modi S, Saura C, Yamashita T, Park YH, Kim SB, Tamura K, Andre F, Iwata H, Ito Y, Tsurutani J, Sohn J, Denduluri N, Perrin C, Aogi K, Tokunaga E, Im SA, Lee KS, Hurvitz SA, Cortes J, Lee C, Chen S, Zhang L, Shahidi J, Yver A, Krop I; DESTINY-Breast01 Investigators. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Breast Cancer. N Engl J Med. 2020 Feb 13;382(7):610-621. doi: 10.1056/NEJMoa1914510. Epub 2019 Dec 11.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2016-004986-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
JapicCTI-173693(en)
Identifier Type: REGISTRY
Identifier Source: secondary_id
DESTINY-Breast01
Identifier Type: OTHER
Identifier Source: secondary_id
DS8201-A-U201
Identifier Type: -
Identifier Source: org_study_id
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