Breast Cancer Clinical Trial
Trastuzumab Deruxtecan (DS-8201a) Versus Investigator’s Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]
Summary
This study will compare DS-8201a to physician choice standard treatment.
Participants must have HER2-low breast cancer that has been treated before.
Participants' cancer:
Cannot be removed by an operation
Has spread to other parts of the body
Full Description
This is a randomized, 2-arm, Phase 3, open-label, multicenter study to compare the safety and efficacy of trastuzumab deruxtecan versus the physician's choice (2:1) in HER2-low, unresectable and/or metastatic breast cancer participants.
The Sponsor proposes to define a new HER2-low population in this trial including tumors with IHC 1+ and IHC 2+/ISH- HER2 expression.
Eligibility Criteria
Inclusion Criteria:
Is the age of majority in their country
Has pathologically documented breast cancer that:
Is unresectable or metastatic
Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested)
Is HR-positive or HR-negative
Has progressed on, and would no longer benefit from, endocrine therapy
Has been treated with 1 to 2 prior lines of chemotherapy/adjuvant in the recurrent or metastatic setting
Was never previously HER2-positive (ICH 3+ or ISH+) on prior pathology testing (per American Society of Clinical Oncology-College of American Pathologists [ASCO-CAP] guidelines)
Has documented radiologic progression (during or after most recent treatment)
Has adequate archival tumor samples available or is wiling to provide fresh biopsies prior to randomization for:
assessment of HER2 status
assessment of post-treatment status
Has at least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors 1.1
Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions
Male and female participants of reproductive/childbearing potential, agrees to follow instructions for method(s) of contraception and agrees to avoid preserving ova or sperm for at least 4.5 months after treatment (or longer, per locally approved labels)
Exclusion Criteria:
Is ineligible for all options in the physician's choice arm
Has breast cancer ever assessed with high-HER2 expression
Has previously been treated with any anti-HER2 therapy, including an antibody drug conjugate
Has uncontrolled or significant cardiovascular disease
Has spinal cord compression or clinically active central nervous system metastases
Has 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 any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study
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There are 202 Locations for this study
Chandler Arizona, 85224, United States
Gilbert Arizona, 85234, United States
Goodyear Arizona, 85338, United States
Los Angeles California, 90095, United States
Palo Alto California, 94305, United States
Redondo Beach California, 90277, United States
San Francisco California, 94158, United States
Norwich Connecticut, 06360, United States
Newark Delaware, 19713, United States
Boca Raton Florida, 33426, United States
Fort Myers Florida, 33916, United States
Hollywood Florida, 33021, United States
Orlando Florida, 32806, United States
Tampa Florida, 33139, United States
Newnan Georgia, 30263, United States
Chicago Illinois, 60637, United States
Zion Illinois, 60099, United States
Wichita Kansas, 67214, United States
New Orleans Louisiana, 70115, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48202, United States
Kansas City Missouri, 64111, United States
Livingston New Jersey, 07039, United States
New York New York, 10016, United States
New York New York, 10065, United States
New York New York, 10065, United States
Cleveland Ohio, 44195, United States
Portland Oregon, 97239, United States
Pittsburgh Pennsylvania, 15212, United States
Pittsburgh Pennsylvania, 15219, United States
Greenville South Carolina, 29601, United States
Knoxville Tennessee, 37909, United States
Memphis Tennessee, 38120, United States
Nashville Tennessee, 37201, United States
Dallas Texas, 75234, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Fairfax Virginia, 22031, United States
Innsbruck , 6020, Austria
Linz , 4020, Austria
Salzburg , 5020, Austria
Vienna , 1090, Austria
Wels , 4600, Austria
Bruxelles , 1000, Belgium
Bruxelles , 1090, Belgium
Bruxelles , 1200, Belgium
Leuven , 3000, Belgium
Loverval , 6280, Belgium
Namur , 5000, Belgium
Tournai , 7500, Belgium
Calgary Alberta, T2N4N, Canada
Toronto Ontario, M4N 3, Canada
Montréal Quebec, H2W 1, Canada
Hefei Anhui, 23000, China
Beijing Beijing, 10002, China
Beijing Beijing, 10085, China
Fuzhou Fujian, 35002, China
Guangzhou Guangdong, 51012, China
Harbin Heilongjiang, 15008, China
Wuhan Hubei, 43007, China
Nanjing Jiangsu, 21000, China
Chang chun Jilin, 13000, China
Chang chun Jilin, 13001, China
Shenyang Liaoning, 11004, China
Yinchuan Ningxia, 75000, China
Linyi Shandong, 27600, China
Shanghai Shanghai, 20008, China
Shanghai Shanghai, 20032, China
Chengdu Sichuan, 61004, China
Hangzhou Zhejiang, 31001, China
Hangzhou Zhejiang, 31002, China
Marseille cedex 9 Bouches-du-Rhône, 13009, France
Caen Calvados, 14076, France
Plérin Cotes d'Armor, 22190, France
Brest Cedex Finistere, 29609, France
Bordeaux cedex Gironde, 33076, France
Montpellier Herault, 34070, France
Montpellier Herault, 34298, France
Rennes-cedex Ille Et Vilaine, 35042, France
Saint-Herblain Loire Atlantique, 44805, France
Le Puy-en-Velay Loiret, 43012, France
Angers Cedex 2 Maine Et Loire, 49055, France
Valenciennes Nord, 59322, France
Paris Cedex 10 Paris, 75475, France
Le Mans Cedex 02 Sarthe, 72015, France
Avignon Cedex 9 Vaculuse, 84918, France
Saint Mande Val De Marne, 94160, France
Villejuif cedex Val De Marne, 94805, France
Paris , 75005, France
Paris , 75020, France
Heidelberg Baden Wuerttemberg, 69120, Germany
Munich Bayern, 81377, Germany
Athens , 11528, Greece
Athens , 14564, Greece
Athens , 15125, Greece
Heraklion , 71110, Greece
Larissa , 41110, Greece
ThessalonÃki , 54622, Greece
ThessalonÃki , 54645, Greece
ThessalonÃki , 56429, Greece
ThessalonÃki , 57001, Greece
Budapest , 1097, Hungary
Budapest , 1122, Hungary
Debrecen , 4032, Hungary
Gyula , 5700, Hungary
Nyiregyhaza , 4400, Hungary
Szolnok , 5004, Hungary
Haifa , 31096, Israel
Jerusalem , 91031, Israel
Jerusalem , 91120, Israel
Petah tikva , 49100, Israel
Ramat Gan , 52363, Israel
Rechovot , 76100, Israel
Safed , 13100, Israel
Tel Aviv , 64239, Israel
Tricase Lecce, 73039, Italy
Monza Milano, 20900, Italy
Rozzano Milano, 20089, Italy
Negrar Verona, 37024, Italy
Bologna , 40138, Italy
Brescia , 25100, Italy
Catania , 95125, Italy
Catanzaro , 88100, Italy
Milano , 20141, Italy
Napoli , 80131, Italy
Rimini , 47923, Italy
Roma , 00133, Italy
Roma , 00168, Italy
Nagoya Aichi-Ken, 464-8, Japan
Kashiwa-shi Chiba-Ken, 277-8, Japan
Matsuyama-shi Ehime-Ken, 791-0, Japan
Fukuoka-shi Fukuoka-Ken, 811-1, Japan
Fukushima Fukushima-Ken, 960-1, Japan
Hiroshima-shi Hiroshima-Ken, 730-8, Japan
Sapporo-shi Hokkaido, 003-0, Japan
Nishinomiya-shi Hyogo-Ken, 663-8, Japan
Kagoshima Kagoshima-Ken, 892-0, Japan
Isehara Kanagawa-Ken, 259-1, Japan
Yokohama Kanagawa, 241-8, Japan
Osaka-shi Osaka-Fu, 540-0, Japan
Onohigashi Osakasayama-shi, 589-8, Japan
Kitaadachi-gun Saitama-Ken, 362-0, Japan
Sunto-gun Shizuoka-Ken, 411-8, Japan
Koto-Ku Tokyo-To, 135-8, Japan
Minato-Ku Tokyo-To, 105-8, Japan
Shinagawa-Ku Tokyo-To, 142-8, Japan
Cheongju-si Chungcheongbuk-do, 361-7, Korea, Republic of
Goyang-si Gyeonggi-do, 10408, Korea, Republic of
Incheon Gyeonggi-do, 22332, Korea, Republic of
Seongnam-si Gyeonggi-do, 13620, Korea, Republic of
Suwon Gyeonggi-do, 16499, Korea, Republic of
Daegu , 41404, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Seoul , 120-7, Korea, Republic of
Braga , 4710-, Portugal
Guimarães , 4835-, Portugal
Lisboa , 1400-, Portugal
Lisboa , 1649-, Portugal
Matosinhos , 4464-, Portugal
Porto , 4099-, Portugal
Porto , 4200-, Portugal
Santa Maria Da Feira , 4520-, Portugal
Vila Nova De Gaia , 4434-, Portugal
Vila Real , 5000-, Portugal
Moscow , 11547, Russian Federation
Moscow , 14342, Russian Federation
Yaroslavl , 15005, Russian Federation
L'Hospitalet De Llobregat Barcelona, 08908, Spain
San Sebastián Guipuzcoa, 20014, Spain
A Coruña La Coruña, 15006, Spain
San Cristobal de la Laguna Tenerife, 38320, Spain
Bilbao Vizcaya, 48013, Spain
Barcelona , 08003, Spain
Barcelona , 08023, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Madrid , 28033, Spain
Madrid , 28034, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Málaga , 29010, Spain
Sevilla , 41009, Spain
Sevilla , 41013, Spain
Valencia , 46009, Spain
Valencia , 46014, Spain
Solna , 17176, Sweden
Sundsvall , 85186, Sweden
Uppsala , 75185, Sweden
Aarau , 5000, Switzerland
Basel , 4031, Switzerland
Chur , 7000, Switzerland
Lausanne , 1011, Switzerland
Saint Gallen , 9007, Switzerland
Winterthur , 8401, Switzerland
Zürich , 8091, Switzerland
Kaohsiung , 807, Taiwan
Tainan , 704, Taiwan
Taipei , 100, Taiwan
Truro Cornwall, TR1 3, United Kingdom
London Greater London, EC1M , United Kingdom
London Greater London, NW1 2, United Kingdom
London Greater London, NW3 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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