Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]
NCT ID: NCT03734029
Last Updated: 2025-10-06
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
557 participants
INTERVENTIONAL
2018-12-27
2026-08-01
Brief Summary
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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
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Detailed Description
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The Sponsor proposes to define a new HER2-low population in this trial including tumors with IHC 1+ and IHC 2+/ISH- HER2 expression.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Trastuzumab deruxtecan
HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to DS8201a
Trastuzumab deruxtecan (DS-8201a)
DS-8201a is a lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered intravenously
Physician's Choice
HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to Physician's choice from the following options:
* Capecitabine
* Eribulin
* Gemcitabine
* Paclitaxel
* Nab-paclitaxel
Capecitabine
Administered according to label, as one option for Physician's Choice (determined before randomization)
Eribulin
Administered according to label, as one option for Physician's Choice (determined before randomization)
Gemcitabine
Administered according to label, as one option for Physician's Choice (determined before randomization)
Paclitaxel
Administered according to label, as one option for Physician's Choice (determined before randomization)
Nab-paclitaxel
Administered according to label, as one option for Physician's Choice (determined before randomization)
Interventions
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Trastuzumab deruxtecan (DS-8201a)
DS-8201a is a lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered intravenously
Capecitabine
Administered according to label, as one option for Physician's Choice (determined before randomization)
Eribulin
Administered according to label, as one option for Physician's Choice (determined before randomization)
Gemcitabine
Administered according to label, as one option for Physician's Choice (determined before randomization)
Paclitaxel
Administered according to label, as one option for Physician's Choice (determined before randomization)
Nab-paclitaxel
Administered according to label, as one option for Physician's Choice (determined before randomization)
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 low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested)
3. Is HR-positive or HR-negative
4. Has progressed on, and would no longer benefit from, endocrine therapy
5. Has been treated with 1 to 2 prior lines of chemotherapy/adjuvant in the recurrent or metastatic setting
6. 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:
1. assessment of HER2 status
2. 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
* 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
18 Years
ALL
No
Sponsors
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Daiichi Sankyo Co., Ltd.
INDUSTRY
AstraZeneca
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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Ironwood Cancer & Research Centers - Chandler II
Chandler, Arizona, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Cancer Treatment Centers of America at Western Regional Medical Center
Goodyear, Arizona, United States
UCLA School of Medicine
Los Angeles, California, United States
Stanford Cancer Institute
Palo Alto, California, United States
Cancer Care Associates Medical Group, Inc. TORI
Redondo Beach, California, United States
University of California at San Francisco (PARENT)
San Francisco, California, United States
Eastern Connecticut Hematology/Oncology Assoc.
Norwich, Connecticut, United States
Christiana Care Health Services, Inc.
Newark, Delaware, United States
Sylvester Comprehensive Cancer Center - Deerfield Beach
Boca Raton, Florida, United States
Florida Cancer Specialists (South Region)
Fort Myers, Florida, United States
Memorial Healthcare System MRH Cancer Center
Hollywood, Florida, United States
Orlando Health, Inc.
Orlando, Florida, United States
Moffitt Cancer Center -Tampa
Tampa, Florida, United States
Cancer Treatment Centers of America-Georgia
Newnan, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Cancer Treatment Centers of America
Zion, Illinois, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Touro Infirmary
New Orleans, Louisiana, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Saint Barnabas Medical Center
Livingston, New Jersey, United States
New York University Medical Center
New York, New York, United States
Memorial Sloan Kettering Hospital
New York, New York, United States
Weill Cornell Medicine Breast Center
New York, New York, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center Health System
Pittsburgh, Pennsylvania, United States
St Francis Hospital
Greenville, South Carolina, United States
Brig Center for Cancer Care and Survivorship
Knoxville, Tennessee, United States
Baptist Cancer Center
Memphis, Tennessee, United States
Tennessee Oncology - Skyline Satellite
Nashville, Tennessee, United States
BloomTrials Clinical Research, LLC
Dallas, Texas, United States
The Methodist Hospital Research Institute
Houston, Texas, United States
University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics
Houston, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Medizinische Universität Innsbruck
Innsbruck, , Austria
Kepler Universitätsklinikum
Linz, , Austria
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, , Austria
AKH - Medizinische Universität Wien (4305)
Vienna, , Austria
Klinikum Wels-Grieskirchen GmbH
Wels, , Austria
Institut Jules Bordet
Brussels, , Belgium
Universitair Ziekenhuis Brussel
Brussels, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
Grand Hôpital de Charleroi
Loverval, , Belgium
CHU UCL Namur
Namur, , Belgium
Centre Hospitalier Wallonie picarde - Site IMC
Tournai, , Belgium
Tom Baker Cancer Center
Calgary, Alberta, Canada
Toronto Sunnybrook Hospital
Toronto, Ontario, Canada
McGill University - Dept. Oncology Clinical Research Program
Montreal, Quebec, Canada
Anhui Provincial Hospital
Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Fuzhou General Hospital of Nanjing Military Area Command of Chinese PLA
Fuzhou, Fujian, China
Sun Yat-sen Memorial hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Hubei Cancer Hospital
Wuhan, Hubei, China
The Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
Jilin Cancer Hospital
Changchun, Jilin, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia Hui, China
Linyi Cancer Hospital
Linyi, Shandong, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Institut Paoli Calmettes
Marseille, Bouches-du-Rhône, France
Centre François Baclesse
Caen, Calvados, France
CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie
Plérin, Cotes d'Armor, France
CHU Brest - Hôpital Morvan
Brest, Finistere, France
Institut Bergonié
Bordeaux, Gironde, France
Clinique Clementville
Montpellier, Herault, France
Institut Régional du Cancer de Montpellier
Montpellier, Herault, France
CRLCC Eugene Marquis
Rennes, Ille Et Vilaine, France
ICO - Site René Gauducheau
Saint-Herblain, Loire Atlantique, France
Centre Hospitalier Emile Roux
Le Puy-en-Velay, Loiret, France
ICO - Site Paul Papin
Angers, Maine Et Loire, France
Centre Hospitalier Valenciennes
Valenciennes, Nord, France
Hôpital Saint-Louis - Paris
Paris, Paris, France
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, Sarthe, France
Institut Sainte Catherine
Avignon, Vaculuse, France
Hôpital d'Instruction des Armees Begin*
Saint-Mandé, Val De Marne, France
Institut Gustave Roussy
Villejuif, Val De Marne, France
Institut Curie - site de Paris
Paris, , France
Hopital Tenon
Paris, , France
Universitaetsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Klinikum der Universitaet Muenchen - Campus Grosshardern
Munich, Bavaria, Germany
General Hospital of Athens "Alexandra"
Athens, , Greece
General Oncology Hospital of Kifissia " Agioi Anargyroi"
Athens, , Greece
Athens Medical Center
Athens, , Greece
University General Hospital of Heraklion
Heraklion, , Greece
University General Hospital of Larissa
Larissa, , Greece
Bioclinic Thessaloniki
Thessaloniki, , Greece
Euromedica General Clinic Thessaloniki
Thessaloniki, , Greece
General Hospital Papageorgiou
Thessaloniki, , Greece
Interbalkan Hospital of Thessaloniki
Thessaloniki, , Greece
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
Budapest, , Hungary
Orszagos Onkologiai Intezet
Budapest, , Hungary
Debreceni Egyetem
Debrecen, , Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
Gyula, , Hungary
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
Nyíregyháza, , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
Szolnok, , Hungary
Rambam Health Care Center
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, , Israel
Rabin Medical Center-Beilinson Campus
Petah Tikva, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
Kaplan Medical Center
Rehovot, , Israel
Ziv Medical Center
Safed, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Azienda Ospedaliera Card. G. Panico
Tricase, Lecce, Italy
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
Monza, Milano, Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy
Ospedale Sacro Cuore Don Calabria
Negrar, Verona, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, , Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia, , Italy
Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico
Catania, , Italy
Azienda Ospedaliero Universitaria Mater Domini-Campus Universitario
Catanzaro, , Italy
IEO Istituto Europeo di Oncologia
Milan, , Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, , Italy
Ospedale degli Infermi
Rimini, , Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Roma, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, , Italy
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
NHO Shikoku Cancer Center
Matsuyama, Ehime, Japan
NHO Kyushu Cancer Center
Fukuoka, Fukuoka, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Hiroshima, Japan
NHO Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
Hyogo College of Medicine Hospital
Nishinomiya-shi, Hyōgo, Japan
Hakuaikai Sagara Hospital
Kagoshima, Kagoshima-ken, Japan
Tokai University Hospital
Isehara, Kanagawa, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
NHO Osaka National Hospital
Osaka, Osaka, Japan
Kindai University Hospital
Onohigashi, Osakasayama-shi, Japan
Saitama Cancer Center
Kitaadachi-gun, Saitama, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan
Cancer Institute Hospital of JFCR
Kōtoku, Tokyo-To, Japan
Toranomon Hospital
Minatoku, Tokyo-To, Japan
Showa University Hospital
Shinagawa-Ku, Tokyo-To, Japan
Hospital de Braga
Braga, , Portugal
Centro Hospitalar do Alto do Ave, EPE
Guimarães, , Portugal
Fundação Champalimaud
Lisbon, , Portugal
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon, , Portugal
Unidade Local de Saúde de Matosinhos, EPE (Hospital Pedro Hispano)
Matosinhos Municipality, , Portugal
Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António
Porto, , Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto, , Portugal
Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião
Santa Maria da Feira, , Portugal
Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
Vila Nova de Gaia, , Portugal
Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE
Vila Real, , Portugal
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
Moscow, , Russia
SBIH of Moscow City "Moscow City Oncology Hospital №62" of Moscow Healthcare Departement
Moscow, , Russia
SBIH of Yaroslavl Region "Regional Clinical Oncological Hospital"
Yaroslavl, , Russia
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Inha University Hospital
Incheon, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Kyungpook National University Chilgok Hospital
Daegu, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Donostia
San Sebastián, Guipuzcoa, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, La Coruña, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, Spain
Hospital de Basurto
Bilbao, Vizcaya, Spain
Hospital del Mar
Barcelona, , Spain
Hospital Quironsalud Barcelona
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
MD Anderson Cancer Centre
Madrid, , Spain
Hospital Ruber Internacional
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario Clinico San Carlos
Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Instituto Valenciano de Oncologia IVO
Valencia, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Karolinska universitetssjukhuset - Solna
Solna, , Sweden
Länssjukhuset Sundsvall-Härnösand
Sundsvall, , Sweden
Akademiska Sjukhuset
Uppsala, , Sweden
Hirslanden Medical Center
Aarau, , Switzerland
Universitaetsspital Basel
Basel, , Switzerland
Kantonsspital Graubuenden
Chur, , Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
Kantonsspital Winterthur
Winterthur, , Switzerland
Universitaetsspital Zuerich
Zurich, , Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Royal Cornwall Hospital
Truro, Cornwall, United Kingdom
Queen Mary University of London
London, Greater London, United Kingdom
University College London Hospitals
London, Greater London, United Kingdom
Royal Free Hospital
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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Modi S, Jacot W, Yamashita T, Sohn J, Vidal M, Tokunaga E, Tsurutani J, Ueno NT, Prat A, Chae YS, Lee KS, Niikura N, Park YH, Xu B, Wang X, Gil-Gil M, Li W, Pierga JY, Im SA, Moore HCF, Rugo HS, Yerushalmi R, Zagouri F, Gombos A, Kim SB, Liu Q, Luo T, Saura C, Schmid P, Sun T, Gambhire D, Yung L, Wang Y, Singh J, Vitazka P, Meinhardt G, Harbeck N, Cameron DA; DESTINY-Breast04 Trial Investigators. Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer. N Engl J Med. 2022 Jul 7;387(1):9-20. doi: 10.1056/NEJMoa2203690. Epub 2022 Jun 5.
Modi S, Jacot W, Iwata H, Park YH, Vidal Losada M, Li W, Tsurutani J, Ueno NT, Zaman K, Prat A, Papazisis K, Rugo HS, Yamashita T, Harbeck N, Im SA, De Laurentiis M, Pierga JY, Wang X, Gombos A, Tokunaga E, Orbegoso Aguilar C, Yung L, Xiao F, Cheng Y, Cameron D. Trastuzumab deruxtecan in HER2-low metastatic breast cancer: long-term survival analysis of the randomized, phase 3 DESTINY-Breast04 trial. Nat Med. 2025 Oct 8. doi: 10.1038/s41591-025-03981-4. Online ahead of print.
Ueno NT, Cottone F, Dunton K, Jacot W, Yamashita T, Sohn J, Tokunaga E, Prat A, Tsurutani J, Park YH, Rugo HS, Xu B, Cardoso F, Mitri Z, Mahtani R, Aguilar CO, Xiao F, Harbeck N, Cameron DA, Modi S. Patient-reported outcomes from DESTINY-Breast04: trastuzumab deruxtecan versus physician's choice of chemotherapy in patients with HER2-low mBC. Oncologist. 2025 May 8;30(5):oyaf048. doi: 10.1093/oncolo/oyaf048.
Yamashita T, Sohn JH, Tokunaga E, Niikura N, Park YH, Lee KS, Chae YS, Xu B, Wang X, Im SA, Li W, Lu YS, Aguilar CO, Nishijima S, Nishiyama Y, Sugihara M, Modi S, Tsurutani J. Trastuzumab deruxtecan versus treatment of physician's choice in previously treated Asian patients with HER2-low unresectable/metastatic breast cancer: subgroup analysis of the DESTINY-Breast04 study. Breast Cancer. 2024 Sep;31(5):858-868. doi: 10.1007/s12282-024-01600-7. Epub 2024 Jun 17.
Ma R, Shi Y, Yan R, Yin S, Bu H, Huang J. Efficacy and safety of trastuzumab deruxtecan in treating human epidermal growth factor receptor 2-low/positive advanced breast cancer:A meta-analysis of randomized controlled trials. Crit Rev Oncol Hematol. 2024 Apr;196:104305. doi: 10.1016/j.critrevonc.2024.104305. Epub 2024 Mar 3.
Jhaveri K, Eli LD, Wildiers H, Hurvitz SA, Guerrero-Zotano A, Unni N, Brufsky A, Park H, Waisman J, Yang ES, Spanggaard I, Reid S, Burkard ME, Vinayak S, Prat A, Arnedos M, Bidard FC, Loi S, Crown J, Bhave M, Piha-Paul SA, Suga JM, Chia S, Saura C, Garcia-Saenz JA, Gambardella V, de Miguel MJ, Gal-Yam EN, Rapael A, Stemmer SM, Ma C, Hanker AB, Ye D, Goldman JW, Bose R, Peterson L, Bell JSK, Frazier A, DiPrimeo D, Wong A, Arteaga CL, Solit DB. Neratinib + fulvestrant + trastuzumab for HR-positive, HER2-negative, HER2-mutant metastatic breast cancer: outcomes and biomarker analysis from the SUMMIT trial. Ann Oncol. 2023 Oct;34(10):885-898. doi: 10.1016/j.annonc.2023.08.003. Epub 2023 Aug 18.
Rugo HS, Crossno CL, Gesthalter YB, Kelley K, Moore HB, Rimawi MF, Westbrook KE, Buys SS. Real-World Perspectives and Practices for Pneumonitis/Interstitial Lung Disease Associated With Trastuzumab Deruxtecan Use in Human Epidermal Growth Factor Receptor 2-Expressing Metastatic Breast Cancer. JCO Oncol Pract. 2023 Aug;19(8):539-546. doi: 10.1200/OP.22.00480. Epub 2023 May 19.
Narayan P, Dilawari A, Osgood C, Feng Z, Bloomquist E, Pierce WF, Jafri S, Kalavar S, Kondratovich M, Jha P, Ghosh S, Tang S, Pazdur R, Beaver JA, Amiri-Kordestani L. US Food and Drug Administration Approval Summary: Fam-Trastuzumab Deruxtecan-nxki for Human Epidermal Growth Factor Receptor 2-Low Unresectable or Metastatic Breast Cancer. J Clin Oncol. 2023 Apr 10;41(11):2108-2116. doi: 10.1200/JCO.22.02447. Epub 2023 Feb 13.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2018-003069-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
184223
Identifier Type: REGISTRY
Identifier Source: secondary_id
DESTINY-B04
Identifier Type: OTHER
Identifier Source: secondary_id
DS8201-A-U303
Identifier Type: -
Identifier Source: org_study_id
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