Breast Cancer Clinical Trial
DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]
Summary
This study will compare DS 8201a to standard treatment.
Participants must have HER2 breast cancer that has been treated before.
Their cancer:
cannot be removed by an operation
has spread to other parts of the body
Full Description
The study is designed to compare DS 8201a versus standard of care (investigator's choice) in subjects with unresectable and/or metastatic breast cancer previously treated with T-DM1.
Eligibility Criteria
Inclusion Criteria:
Is the age of majority in their country
Has pathologically documented breast cancer that:
is unresectable or metastatic
has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory
was previously treated with ado-trastuzumab emtansine (T-DM1)
Has documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy)
Is HER2 positive as confirmed by central laboratory assessment of most recent tumor tissue sample available. If archived tissue is not available, agrees to provide a fresh biopsy.
Male and female participants of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least:
7 months after the last dose of DS-8201a (females); 4.5 months after last dose of DS-8201a (males)
6 months after the last dose of lapatinib/capecitabine for female participants (3 months for male participants)
7 months after the last dose of trastuzumab/capecitabine
Has adequate hematopoietic, renal and hepatic functions
Exclusion Criteria:
Has previously participated in an antibody drug conjugate study sponsored by Daiichi Sankyo. Prior treatment in the adjuvant/neo-adjuvant setting would be allowed if progression of disease did not occur within 12 months of end of adjuvant therapy
Has had prior treatment with capecitabine
Has uncontrolled or significant cardiovascular disease
Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
Has active central nervous system (CNS) metastases
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There are 220 Locations for this study
Chandler Arizona, 85224, United States
Los Angeles California, 90095, United States
Monterey California, 93940, United States
San Diego California, 92123, United States
Whittier California, 90603, United States
New Haven Connecticut, 06510, United States
Washington District of Columbia, 20010, United States
Fort Myers Florida, 33901, United States
Atlanta Georgia, 30318, United States
Honolulu Hawaii, 96826, United States
Maywood Illinois, 60153, United States
Munster Indiana, 46321, United States
Louisville Kentucky, 40207, United States
Scarborough Maine, 04074, United States
Baltimore Maryland, 21201, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48202, United States
Joplin Missouri, 64804, United States
Kansas City Missouri, 64111, United States
Kansas City Missouri, 64132, United States
Saint Louis Missouri, 63110, United States
East Setauket New York, 11733, United States
New York New York, 10065, United States
Cincinnati Ohio, 45267, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43235, United States
Kettering Ohio, 45409, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15212, United States
Pittsburgh Pennsylvania, 15213, United States
Chattanooga Tennessee, 37404, United States
Germantown Tennessee, 38138, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Tyler Texas, 75708, United States
Ogden Utah, 84405, United States
Fairfax Virginia, 22031, United States
Tacoma Washington, 98405, United States
Darlinghurst New South Wales, 2010, Australia
Liverpool New South Wales, 2170, Australia
Sydney New South Wales, 2109, Australia
Tweed Heads New South Wales, 2485, Australia
Woolloongabba Queensland, 4102, Australia
Kurralta Park South Australia, 5037, Australia
Box Hill Victoria, 3128, Australia
Frankston Victoria, 3199, Australia
Frankston Victoria, 3199, Australia
Heidelberg Victoria, 3084, Australia
Melbourne Victoria, 3000, Australia
Saint Albans Victoria, 3021, Australia
Warrnambool Victoria, 3280, Australia
Wendouree Victoria, 3355, Australia
Subiaco Western Australia, 6008, Australia
Bruce , 2614, Australia
Bruxelles , 1090, Belgium
Bruxelles , 1200, Belgium
Gent , 9000, Belgium
Kortrijk , 8500, Belgium
Leuven , 3000, Belgium
Namur , 5000, Belgium
Salvador Bahia, 40170, Brazil
Salvador Bahia, 41950, Brazil
Fortaleza Ceará, 60810, Brazil
Nova Lima Minas Gerais, 34000, Brazil
Porto Alegre Rio Grande Do Sul, 90110, Brazil
Porto Alegre Rio Grande Do Sul, 90430, Brazil
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Porto Alegre Rio Grande Do Sul, 91350, Brazil
Itajaí Santa Catarina, 88301, Brazil
Santo André Sao Paulo, 09060, Brazil
São Paulo Sao Paulo, 03102, Brazil
Rio De Janeiro , 22793, Brazil
São Paulo , 01308, Brazil
São Paulo , 01509, Brazil
Brno , 625 0, Czechia
Olomouc , 775 2, Czechia
Prague 5 , 150 0, Czechia
Praha , 180 8, Czechia
Marseille cedex 20 Bouches-du-Rhône, 13915, France
Caen Cedex 05 Calvados, 14076, France
Plérin Cotes d'Armor, 22190, France
Dijon cedex Côte-d'Or, 21079, France
Besançon Doubs, 25030, France
Brest Cedex Finistere, 29609, France
Antony Hauts De Seine, 92160, France
Saint-Cloud Hauts De Seine, 92110, France
Montpellier Herault, 34070, France
Montpellier Herault, 34298, France
Rennes cedex Ille Et Vilaine, 35042, France
Lille cedex Nord, 59020, France
Valenciennes Nord, 59300, France
Paris Cedex 05 Paris, 75005, France
Bayonne Cedex Pyrenees Atlantiques, 64109, France
Pierre Benite cedex Rhone, 69495, France
Le Mans Cedex 02 Sarthe, 72015, France
Rouen Seine Maritime, 76038, France
Avignon Cedex 9 Vaculuse, 84918, France
Villejuif cedex Val De Marne, 94805, France
Montpellier , 34298, France
Paris , 75005, France
Paris , 75020, France
Muenchen Bayern, 81675, Germany
Bottrop Rheinland Pfalz, 46236, Germany
Luebeck Schleswig Holstein, 23538, Germany
Berlin , 13125, Germany
Düsseldorf , 40225, Germany
Erlangen , 91054, Germany
Koeln , 51067, Germany
Leipzig , 04103, Germany
Munich , 81377, Germany
Müenster , 48149, Germany
Troisdorf , 53840, Germany
Athens , 11525, Greece
Athens , 11528, Greece
Athens , 14564, Greece
Heraklion , 71110, Greece
Thessaloníki , 54645, Greece
Haifa , 31096, Israel
Jerusalem , 91031, Israel
Jerusalem , 91120, Israel
Kfar Saba , 44281, Israel
Petah tikva , 49100, Israel
Ramat Gan , 52363, Israel
Tel Aviv , 64239, Israel
Monza Milano, 20900, Italy
Aviano Pordenone, 33081, Italy
Negrar Verona, 37024, Italy
Bergamo , 24127, Italy
Bologna , 40138, Italy
Cona , 44124, Italy
Genova , 16132, Italy
Lecco , 23900, Italy
Messina , 98158, Italy
Milano , 20132, Italy
Milano , 20133, Italy
Milano , 20141, Italy
Modena , 41124, Italy
Napoli , 80131, Italy
Padova , 35128, Italy
Parma , 43100, Italy
Pavia , 27100, Italy
Pisa , 56126, Italy
Torino , 10126, Italy
Fukushima-shi Fukushima-Ken, 960-1, Japan
Osakasayama-shi Osaka-Fu, 589-8, Japan
Ōsakasayama-shi Osaka-Fu, 589-8, Japan
Chuo Ku Tokyo-To, 104-0, Japan
Ehime , 791-0, Japan
Fukuoka , 811-1, Japan
Hiroshima , 730-8, Japan
Hokkaido , 003-0, Japan
Hyōgo , 663-8, Japan
Kanagawa , 216-8, Japan
Kanagawa , 241-8, Japan
Kyoto , 606-8, Japan
Miyagi , 980-8, Japan
Nagoya , 464-8, Japan
Niigata , 951-8, Japan
Okayama , 700-8, Japan
Osaka , 540-0, Japan
Osaka , 541-8, Japan
Saitama , 362-0, Japan
Shizuoka , 411-8, Japan
Tokyo , 105-8, Japan
Tokyo , 135-8, Japan
Tokyo , 160-0, Japan
Cheongju-si Chungcheongbuk-do, 28644, Korea, Republic of
Incheon Gyeonggi-do, 22332, Korea, Republic of
Seongnam-si Gyeonggi-do, 13620, Korea, Republic of
Suwon-si Gyeonggi-do, 16247, Korea, Republic of
Suwon Gyeonggi-do, 16499, Korea, Republic of
Daegu , 41404, Korea, Republic of
Goyang-si , 10408, Korea, Republic of
Seoul , 02841, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03772, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Badalona Barcelona, 08916, Spain
L'Hospitalet De Llobregat Barcelona, 08908, Spain
Jerez De La Frontera Cádiz, 11407, Spain
A Coruña La Coruña, 15006, Spain
San Cristobal de la Laguna Tenerife, 38320, Spain
Badajoz , 06007, Spain
Barcelona , 08023, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Barcelona , 8003, Spain
Lleida , 25198, Spain
Madrid , 28007, Spain
Madrid , 28033, Spain
Madrid , 28040, Spain
Málaga , 29010, Spain
Salamanca , 37370, Spain
Sevilla , 41009, Spain
Sevilla , 41013, Spain
Valencia , 46009, Spain
Zaragoza , 50009, Spain
Adana , 01130, Turkey
Adana , 01370, Turkey
Ankara , 6800, Turkey
Antalya , 07058, Turkey
Bursa , 16059, Turkey
Istanbul , 34098, Turkey
Istanbul , 34147, Turkey
Istanbul , 34214, Turkey
Istanbul , 34732, Turkey
Istanbul , 34854, Turkey
Istanbul , 34890, Turkey
İzmir , 35530, Turkey
Konya , 42080, Turkey
Sakarya , 54187, Turkey
Samsun , 55200, Turkey
Tekirdağ , 59100, Turkey
Truro Cornwall, TR1 3, United Kingdom
Exeter Devon, EX2 5, United Kingdom
Plymouth Devon, PL6 8, United Kingdom
Aberdeen Grampian Region, AB25 , United Kingdom
London Greater London, EC1M , United Kingdom
London Greater London, NW1 2, United Kingdom
London Greater London, W1G 6, United Kingdom
Edinburgh Lothian Region, EH4 2, United Kingdom
Nottingham Nottinghamshire, NG5 1, United Kingdom
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