Breast Cancer Clinical Trial
DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]
Summary
This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.
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 trastuzumab and taxane in the advanced/metastatic setting or progressed within 6 months after neoadjuvant or adjuvant treatment involving a regimen including trastuzumab and taxane
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.
If of reproductive/childbearing potential, agrees to use a highly effective form of contraception or avoid intercourse during and upon completion of the study for 7 months after the last dose of DS-8201a (females); 4.5 months after last dose of DS-8201a (males) or 7 months after the last dose of T-DM1
Has adequate renal and hepatic function
Exclusion Criteria:
Has previously been treated with an anti-HER2 antibody drug conjugate (ADC) in the metastatic setting. 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 uncontrolled or significant cardiovascular disease
Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
Has spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
Participants with clinically inactive brain metastases may be included in the study.
Participants with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment.
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There are 161 Locations for this study
Los Angeles California, 90095, United States
San Diego California, 92123, United States
San Francisco California, 94115, United States
Whittier California, 90603, United States
Washington District of Columbia, 20010, United States
Fort Myers Florida, 33916, United States
Saint Petersburg Florida, 33705, United States
Atlanta Georgia, 30318, United States
Maywood Illinois, 60153, United States
Louisville Kentucky, 40207, United States
Boston Massachusetts, 02215, United States
Omaha Nebraska, 68198, United States
East Setauket New York, 11733, United States
Rochester New York, 14642, United States
Winston-Salem North Carolina, 27157, United States
Cincinnati Ohio, 45267, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43210, United States
Kettering Ohio, 45409, United States
Pittsburgh Pennsylvania, 15213, United States
Nashville Tennessee, 37205, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Houston Texas, 77090, United States
Tyler Texas, 75708, United States
Auburn Washington, 98001, United States
Tweed Heads New South Wales, 2485, Australia
Woolloongabba Queensland, 4102, Australia
Box Hill Victoria, 3128, Australia
Frankston Victoria, 3199, Australia
Melbourne Victoria, 3000, Australia
Subiaco Western Australia, 6008, Australia
Bruxelles , 1000, Belgium
Bruxelles , 1090, Belgium
Edegem , 2650, Belgium
Gent , 9000, Belgium
Leuven , 3000, Belgium
Namur , 5000, Belgium
Salvador Bahia, 40170, Brazil
Porto Alegre Rio Grande Do Sul, 91350, Brazil
Itajaí Santa Catarina, 88301, Brazil
Santo André Sao Paulo, 09060, Brazil
São Paulo Sao Paulo, 01246, Brazil
São Paulo Sao Paulo, 01317, Brazil
Rio De Janeiro , 22793, Brazil
São Paulo , 01509, Brazil
Calgary Alberta, T2N 4, Canada
Toronto Ontario, M4N 3, Canada
Montréal Quebec, H3T 1, Canada
Beijing Beijing, 10002, China
Beijing Beijing, 10073, China
Guangzhou Guangdong, 51006, China
Guangzhou Guangdong, 51012, China
Harbin Heilongjiang, 15008, China
Chang chun Jilin, 13002, China
Shenyang Liaoning, 11004, China
Shanghai Shanghai, 20003, China
Chengdu Sichuan, 61004, China
Tianjin Tianjin, 30006, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31002, China
Strasbourg Cedex Bas Rhin, 67000, France
Marseille Cedex 20 Bouches-du-Rhone, 13915, France
Caen Cedex 05 Calvados, 14076, France
Le Mans Cedex 02, Sarthe, 72015, France
Plérin Cotes d'Armor, 22190, France
Dijon cedex Côte-d'Or, 21079, France
Besançon Doubs, 25030, France
Bordeaux cedex Gironde, 33076, France
Saint-Cloud Hauts De Seine, 92110, France
Montpellier Herault, 34298, France
Rennes cedex Ille Et Vilaine, 35042, France
Saint-Herblain Loire Atlantique, 44805, France
Angers Cedex 2 Maine Et Loire, 49055, France
Valenciennes Nord, 59300, France
Lyon Cedex 08 Rhone, 69373, France
Pierre Benite Cedex Rhone, 69495, France
Avignon Cedex 9 Vaculuse, 84918, France
Saint-Mandé Val De Marne, 94160, France
Villejuif cedex Val De Marne, 94805, France
Paris , 75005, France
Paris , 75010, France
Paris , 75020, France
Erlangen Bayern, 91-54, Germany
Muenchen Bayern, 80637, Germany
Muenchen Bayern, 81675, Germany
Düsseldorf Nordrhein Westfalen, 40225, Germany
Troisdorf Nordrhein Westfalen, 53840, Germany
Bottrop Rheinland Pfalz, 46236, Germany
Luebeck Schleswig Holstein, 23538, Germany
Hong Kong , 00000, Hong Kong
Shatin , 00000, Hong Kong
Cona Ferrara, 44124, Italy
Monza Milano, 20900, Italy
Rozzano Milano, 20089, Italy
Aviano Pordenone, 33081, Italy
Bergamo , 24127, Italy
Bologna , 40138, Italy
Genova , 16132, Italy
Lecco , 23900, Italy
Messina , 98158, Italy
Milano , 20132, Italy
Milano , 20141, Italy
Modena , 41124, Italy
Napoli , 80131, Italy
Parma , 43100, Italy
Pavia , 27100, Italy
Torino , 10126, Italy
Shinjuku-Ku Tokyo-To, 162-8, Japan
Aichi , 464-8, Japan
Ehime , 791-0, Japan
Fukuoka , 811-1, Japan
Hiroshima , 730-8, Japan
Hokkaido , 003-0, Japan
Kanagawa , 241-8, Japan
Kumamoto , 860-8, 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 , 104-0, Japan
Tokyo , 135-8, Japan
Tokyo , 142-8, Japan
Seongnam-si Gyeonggi-do, 13620, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
L'Hospitalet De Llobregat Barcelona, 08908, Spain
A Coruña La Coruña, 15006, Spain
Santiago De Compostela La Coruña, 15706, Spain
Majadahonda Madrid, 28222, Spain
Sevilla Sevill, 41009, Spain
San Cristobal de la Laguna Tenerife, 38320, Spain
Badajoz , 6007, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Barcelona , 8023, Spain
Madrid , 28007, Spain
Madrid , 28033, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Málaga , 29010, Spain
Sevilla , 41013, Spain
Taichung , 40447, Taiwan
Tainan , 704, Taiwan
Taipei , 100, Taiwan
Taipei , 11217, Taiwan
Taipei , 112, Taiwan
Exeter Devon, EX2 5, United Kingdom
Aberdeen Grampian Region, AB25 , United Kingdom
London Greater London, EC1M , United Kingdom
London Greater London, NW1 2, United Kingdom
London Greater London, SE1 9, United Kingdom
London Greater London, W1G 6, United Kingdom
Manchester Greater Manchester, M20 4, 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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