Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy
ASCENT-07
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH-]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy
6 other identifiers
interventional
654
27 countries
278
Brief Summary
The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available standard treatments, such as paclitaxel, nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative to the treatment of physician's choice (TPC) on progression-free survival (PFS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2023
Longer than P75 for phase_3
278 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2023
CompletedFirst Posted
Study publicly available on registry
May 3, 2023
CompletedStudy Start
First participant enrolled
May 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
October 3, 2025
September 1, 2025
4.9 years
April 21, 2023
September 30, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
PFS is defined as time from date of randomization until the date of first objective progressive disease (PD) or death from any cause, whichever comes first.
Up to approximately 29 months
Secondary Outcomes (9)
Overall Survival (OS)
Until death, up to approximately 60 months
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
Until progression, up to approximately 60 months
Change from Baseline in the Physical Functioning Domain Using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) at Week 16
Baseline, Week 16
Time to Deterioration in Version 3.0 EORTC-QLQ-C30 Scores
Up to approximately 60 months
Progression Free Survival (PFS) as Assessed by Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Until progression or death, up to approximately 60 months
- +4 more secondary outcomes
Study Arms (2)
Sacituzumab Govitecan-hziy (SG)
EXPERIMENTALParticipants will receive SG at a dose of 10 mg/kg infusion on Days 1 and 8 of a 21-day cycle.
Treatment of Physician's Choice (TPC)
ACTIVE COMPARATORParticipants will receive TPC determined prior to randomization to 1 of the 3 allowed regimens: * paclitaxel 80 mg/m\^2 over 1 hour (± 10 minutes) on Days 1, 8, and 15 of a 28-day cycle. * nab-Paclitaxel 100 mg/m\^2 over 30 minutes (± 10 minutes) on Days 1, 8, and 15 of a 28-day cycle. * capecitabine at 1000-1250 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period of a 21-day cycle.
Interventions
Administered intravenously
Administered intravenously
Eligibility Criteria
You may qualify if:
- Able to understand and give written informed consent.
- Must have adequate tumor tissue sample preferably from locally recurrent or metastatic site.
- Documented evidence of HR+ metastatic breast cancer (mBC) confirmed with the most recently available tumor biopsy preferably from a locally recurrent or metastatic site.
- Documented evidence of HER2- status.
- Documented PD by computed tomography (CT) or magnetic resonance imaging during or after the most recent therapy per RECIST v1.1 criteria.
- Candidate for the first chemotherapy in the locally advanced or metastatic setting.
- Eligible for capecitabine, nab-paclitaxel, or paclitaxel.
- Individuals must have at least one of the following:
- Disease progression on at least 2 or more previous lines of endocrine therapy (ET) with or without a targeted therapy in the metastatic setting.
- Disease recurrence while on the first 24 months of starting adjuvant ET will be considered a line of therapy; these individuals will only require 1 line of ET in the metastatic setting.
- Disease progression within 6 months of starting first-line ET with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor (if ineligible or if unable to access a CDK 4/6 inhibitor) in the metastatic setting.
- Disease recurrence while on the first 24 months of starting adjuvant ET with CDK 4/6 inhibitor and if the individual is no longer a candidate for additional ET in the metastatic setting.
- Individuals may have received prior targeted therapies, including but not limited to PARP inhibitors (for those with germline BRCA1 or BRCA2 mutations), phosphatidylinositol 3-kinase (PI3K) inhibitors (for those with PIK3CA mutations), or mammalian target of rapamycin (mTOR) inhibitors. However, individuals can no longer be candidates for additional endocrine treatment with or without targeted therapies.
- Individuals with HIV must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease.
- Demonstrates adequate organ function.
- +2 more criteria
You may not qualify if:
- Progressive disease within 6 months of completing (neo)adjuvant chemotherapy.
- Locally advanced metastatic breast cancer (mBC) (Stage IIIc) in individuals who are candidates for curative intent therapy at the time of study enrollment.
- Current enrollment in another clinical study and use of any investigational device or drug (drugs not marketed for any indication) either within 5 half-lives or 28 days prior to randomization, whichever is longer.
- Use of investigational drugs in the category of Selective Estrogen Receptor Degraders are acceptable if last dose was longer than 14 days prior to randomization.
- Received any prior treatment (including antibody-drug conjugate (ADC)) containing a chemotherapeutic agent targeting topoisomerase I.
- Received any prior treatment with a trophoblast cell-surface antigen 2 (Trop-2)-directed ADC.
- Have an active second malignancy.
- Have an active serious infection requiring antibiotics.
- Have active hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Individuals positive for human immunodeficiency virus type 1/2 (HIV-1 or -2) with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
- Have a positive serum pregnancy test or are breastfeeding for individuals who are assigned female at birth.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (288)
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Chandler, Arizona, 85224, United States
Los Angeles Hematology Oncology Medical Group
Los Angeles, California, 90017, United States
Stanford Cancer Institute
Palo Alto, California, 94305, United States
University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94143, United States
Rocky Mountain Cancer Centers, LLP
Littleton, Colorado, 80120, United States
Yale-New Haven Hospital-Yale Cancer Center
New Haven, Connecticut, 06510, United States
Investigational Drug Services, AdventHealth Orlando
Altamonte Springs, Florida, 32701, United States
Florida Cancer Specialists
Brooksville, Florida, 34613, United States
Florida Cancer Specialist
Leesburg, Florida, 34748, United States
Florida Cancer Specialist
St. Petersburg, Florida, 33705, United States
Piedmont Cancer Institute
Atlanta, Georgia, 30318, United States
Georgia Cancer Specialist - Annex
Atlanta, Georgia, 30341, United States
Northwest Georgia Oncology Centers
Marietta, Georgia, 30060, United States
The University of Kansas Hospital
Kansas City, Kansas, 66160, United States
Hematology Oncology Clinic
Baton Rouge, Louisiana, 70809, United States
Saint Luke's Cancer Institute
Kansas City, Missouri, 64110, United States
David C. Pratt Cancer Center
St Louis, Missouri, 63141, United States
Astera Cancer Care
East Brunswick, New Jersey, 08816, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
New York, New York, 10065, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Stefanie Spielman Comprehensive Breast Center
Columbus, Ohio, 43210, United States
Penn State Cancer Institute
Hershey, Pennsylvania, 17033, United States
Magee-Womens of UPMC
Pittsburgh, Pennsylvania, 15213, United States
Prisma Health - Upstate
Greenville, South Carolina, 29605, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203, United States
Vanderbilt University Medical Center - Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37203, United States
US Oncology Investigational Products Center (IPC)
Fairfax, Virginia, 22031, United States
US Oncology Investigational Products Center (IPC)
Norfolk, Virginia, 23502, United States
MultiCare Regional Cancer Center - Auburn
Auburn, Washington, 98001, United States
Hospital Britanico de Buenos Aires
Buenos Aires, 1426, Argentina
Instituto de Investigaciones Clinicas de Mar del Plata
Buenos Aires, B7600, Argentina
Instituto Alexander Fleming
C.a.b.a., 1426ANZ, Argentina
Hospital Alemán
CABA, 1118, Argentina
Centro Privado de RMI Rio Cuarto S.A.
Córdoba, 5800, Argentina
Instituto de Oncología de Rosario
Rosario, 2000, Argentina
CER San Juan Centro Polivalente de Asistencia e Investigación Clínica
San Juan, 5400, Argentina
Royal Brisbane and Women's Hospital
Queensland, ME, 4029, Australia
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
GenesisCare North Shore (Oncology)
St Leonards, New South Wales, 2065, Australia
Icon Cancer Centre Wesley
Auchenflower, Queensland, 4066, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Icon Cancer Centre Hobart
Hobart, Tasmania, 7000, Australia
Austin Health
Melbourne, Victoria, 3084, Australia
Sunshine Hospital (Western Health)
St Albans, Victoria, 3021, Australia
Breast Cancer Research Centre - WA
Nedlands, Western Australia, 6009, Australia
University Hospital Innsbruck
Innsbruck, 06020, Austria
Universitätsklinik für Innere Medizin 3 der PMU
Salzburg, A-5020, Austria
Medizinische Universitat Wien, Univ. Klinik fur Innere Medizin I Klinische Abteilung fur Onkologie
Vienna, 1090, Austria
Klinikum Wels-Grieskirchen
Wels, 4710, Austria
GZA Ziekenhuizen - Campus Sint-Augustinus
Antwerp, 2610, Belgium
AZ Klina
Brasschaat, 2930, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Universitaire Ziekenhuis Leuven
Leuven, 3000, Belgium
CHU UCL Namur-Site STE. Elisabeth
Namur, 5000, Belgium
Hospital Haroldo Juaçaba - Instituto do Câncer do Ceará
Fortaleza, 60430-230, Brazil
Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias
Goiânia, 74605-070, Brazil
Oncosite - Centro de Pesquisa Clinica e Oncologia
Ijuí, 98700-000, Brazil
Catarina Pesquisa Clinica
Itajaí, 88301-220, Brazil
Oncoclinicas do Brasil Servicos Medicos AS
Minas Gerais, 30360-680, Brazil
Liga Norte-Rio-Grandense Contra o Câncer
Natal, 59062-000, Brazil
CIONC-Centro Integrado de Oncologia de Curitiba
Paraana, 80810050, Brazil
Hospital Erasto Gaertner
Paraná, 81.520-060, Brazil
IMIP - Instituto de Medicina Integral Professor Fernando Figueira
Pernambuco, 50070550, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, 90020-090, Brazil
Hospital de Clínicas de Porto Alegre - HCPA
Porto Alegre, 90035-903, Brazil
HGB - Hospital Giovanni Battista/Mãe de Deus Center
Porto Alegre, 90110-270, Brazil
Hospital São Lucas da PUCRS
Porto Alegre, 90610001, Brazil
Instituto Americas
Rio de Janeiro, 22775-001, Brazil
Clínica de Oncologia de Porto Alegre Ltda - CLINIONCO
Rio Grande, 90430-090, Brazil
Unidade de PesquisasClinicas em Oncologia - UPCO
Rio Grande, 96020-080, Brazil
Instituto do Câncer - Hospital São Vicente de Paulo
Rio Grande, 99010-090, Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André, 09060-650, Brazil
Instituto Hemomed Oncologia e Hematologia
São Paulo, 01236-030, Brazil
Clinica de pesquisa e centro de estudos em oncologia ginecológica e mamaria
São Paulo, 1317000, Brazil
BC Cancer - Kelowna
Kelowna, V1Y 5L3, Canada
The Ottawa Hospital Cancer Centre
Ottawa, K1H 8L6, Canada
CHU de Québec-Université Laval, Hôpital du Saint-Sacrement
Québec, G1S 4L8, Canada
Humber River Hospital
Toronto, M3M 0B2, Canada
BC Cancer-Victoria
Victoria, V8R 6V5, Canada
Centro de Investigacion Clinica Bradford Hill
Recoleta, Chile
Centro del Cancer UC
Region Metropolitana, 7550000, Chile
Centro de Oncología de Precisión (COP)
Santiago Region, 8330032, Chile
James Lind Centro de Investigacion del Cancer
Temuco, Chile
Oncocentro APYS
Viña del Mar, 2520612, Chile
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Anhui, 230001, China
Peking University People's Hospital
Beijing, 100044, China
The First Hospital of Jilin University
Changchun, 130021, China
Xiangya Hospital Central South University
Changsha, 410008, China
West China Hospital Sichuan University
Chengdu, 610041, China
Chongqing University Cancer Hospital
Chongqing, 404100, China
Fujian Cancer Hospital
Fujian, 350015, China
Fujian Medical University Union Hospital
Fuzhou, 350001, China
Sun Yat-Sen University Cancer Center
Guangdong, 510060, China
Guangdong Provincial People's Hospital
Guangzhou, 510080, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, 510080, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, 510120, China
Sir Run Run Shaw Hospital,Zhejiang University School of Medicine
Hangzhou, 310000, China
Zhejiang Cancer Hospital
Hangzhou, 310022, China
Harbin Medical University Cancer Hospital
Heilongjiang, 150081, China
Jiangsu Province Hospital
Jiangsu, 210029, China
The First Affiliated Hospital of Soochow University
Jiangsu, 215004, China
The Nanchang Third Hospital
Jiangxi, 330009, China
The Second Hospital of Jilin University
Jilin Sheng, 130041, China
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, 250117, China
The First Affiliated Hospital of Nanchang University
Nanchang, 330006, China
General Hospital of Ningxia Medical University
Ningxia Hui, 750004, China
The Affiliated Hospital Of Qingdao University
Qingdao, 266071, China
Fudan University Shanghai Cancer Center
Shanghai, 200030, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 453000, China
Hubei Cancer Hospital
Wuhan, 430079, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710061, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Zhejiang, 310009, China
Henan Cancer Hospital
Zhengzhou, 450003, China
Fakultni Nemocnice Brno
Brno, 62500, Czechia
Masaryk Memorial Cancer Institute
Brno, 656 53, Czechia
University Hospital Olomouc
Olomouc, 779 00, Czechia
Multiscan s.r.o
Pardubice, 532 01, Czechia
Charles General University Hospital, Prague
Prague, 12808, Czechia
Fakultni nemocnice v Motole
Prague, 14059, Czechia
Krajska nemocnice Tomase Bati Zlin
Zlín, 760 01, Czechia
CHU Jean Minjoz
Besançon, 25030, France
Institut Bergonié
Bordeaux, 33076, France
Centre Georges François Leclerc
Dijon, 21000, France
Centre Oscar Lambret
Lille, 59000, France
Clinique Francois Chenieux
Limoges, 87039, France
Ico René Gauducheau
Loire Atlantique, 44 805, France
Centre Leon Berard
Lyon, 69373, France
Institut Paoli Calmettes
Marseille, 13009, France
Institut Regional du Cancer de Montpellier
Montpellier, 34298, France
Institut Curie
Paris, 75248, France
Centre Hospitalier Lyon-Sud
Pierre-Bénite, 69310, France
Hopital Privé des Cotes d'Armor
Plérin, 22190, France
Centre Jean Bernard Service d'Oncologie Médicale
Rennes, 35042, France
Centre Henri Becquerel
Rouen, France
Institut Universitaire du Cancer de Toulouse Oncopole
Toulouse, 31059, France
Institut Gustave Roussy
Villejuif, 94800, France
Universitaetsklinikum Freiburg, Klinik fuer Frauenheilkunde
Baden-Württemberg, 79106, Germany
University Hospital rechts der Isar Technical University of Munich
Bayern, 81675, Germany
Vivantes Klinikum am Urban
Berlin, 10967, Germany
HELIOS Klinikum Berlin-Buch
Berlin, 13125, Germany
Marienhospital Bottrop
Bottrop, 46236, Germany
Universitätsklinik Erlangen
Erlangen, 91054, Germany
SRH Wald-Klinikum Gera GmbH
Gera, 07548, Germany
Universitatsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
Medizinische Hochschule Hannover
Hanover, D-30625, Germany
Nationales Centrum für Tumorerkrankungen Heidelberg
Heidelberg, 69120, Germany
Universitätsklinikum Mannheim
Mannheim, 68167, Germany
LMU Klinikum der Universitat München
München, 81377, Germany
Universitatsklinikum Munster
Münster, 48149, Germany
Universitäts - Frauenklinik
Tübingen, 72076, Germany
Alexandra General Hospital
Athens, 11528, Greece
Attikon Hospital
Athens, 124 62, Greece
University Hospital of Heraklion
Heraklion, Greece
University Hospital of Larissa
Larissa, 41110, Greece
University Hospital of Patras
Pátrai, 26 500, Greece
Bioclinic of Thessaloniki
Thessaloniki, 546 22, Greece
Euromedica General Clinic of Thessaloniki
Thessaloniki, 546 45, Greece
Hong Kong Integrated Oncology Centre
Hong Kong, 0, Hong Kong
Prince of Wales Hospital
New Territories, Hong Kong
Queen Mary Hospital
Pok Fu Lam, 0, Hong Kong
Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika
Budapest, 1083, Hungary
Debreceni Egyetem Klinikai Központ
Debrecen, 4032, Hungary
Bács-Kiskun Varmegyei Oktatokorhaz, Onkaradiologiai Kozpont
Kecskemét, 6000, Hungary
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz, Onkoradiologia
Nyíregyháza, 4400, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, 6720, Hungary
Oncology Institute Rambam Health Care Campus
Haifa, 31096, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Hadassah Medical Center
Jerusalem, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
Sheba Medical Center
Ramat Gan, 52621, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Ancona AN, 60126, Italy
Centro di Riferimento Oncologico - IRCCS
Aviano, 33081, Italy
Humanitas Gavazzeni
Bergamo, 24125, Italy
ASST Papa Giovanni XXIII
Bergamo, 24127, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola
Bologna, Italy
Humanitas Istituto Clinico Catanese
Catania, 95045, Italy
Azienda Ospedaliera Mater Domini
Catanzaro, 88100, Italy
IRCCS Ospedale Policlinico San Martino
Genova GE, 16132, Italy
Istituto Europeo di Oncologia
Milan, 20141, Italy
Fondazione IRCCS San Raffaele del Monte Tabor
Milan, 20132, Italy
Azienda Ospedaliera San Gerardo
Monza, 20090, Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Napoli, 80131, Italy
Istituto Oncologico Veneto IOV
Padua, 35128, Italy
Irccs Crob
Rionero in Vulture, 85028, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Roma, 161, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 168, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
Aichi Cancer Center Hospital
Aichi, 464-8681, Japan
Tohoku University Hospital
Aoba-ku, 980-8574, Japan
Juntendo University Hospital
Bunkyō City, 113-8431, Japan
Chiba Cancer Center
Chiba, 260-8717, Japan
National Cancer Center Hospital
Chūōku, 1040045, Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
Chūōku, 541-8567, Japan
National Hospital Organization Shikoku Cancer Center
Ehime, 791-0280, Japan
Fukushima Medical University Hospital
Fukushima, Japan
Social Medical Corporation Hakuaikai Sagara Hospital
Kagoshima, 892-0833, Japan
Tokai University Hospital
Kanagawa, 259-1193, Japan
National Cancer Center Hospital East
Kashiwa, 277-8577, Japan
Saitama Cancer Center
Kitaadachi-gun, 362-0806, Japan
Cancer Institute Hospital of JFCR
Kōtoku, 135-8550, Japan
Kumamoto University Hospital
Kumamoto, 860-8556, Japan
Kyoto University Hospital
Kyoto, 606-8507, Japan
National Hospital Organization Kyushu Cancer Center
Minamiku, 811-1395, Japan
Nagoya University Hospital
Nagoya, 466-8560, Japan
Hiroshima City Hiroshima Citizens Hospital
Nakaku, 730-8518, Japan
Hyogo Medical University Hospital
Nishinomiya-shi, 663-8501, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
Gunma Prefectural Cancer Center
Ōta-ku, 373-8550, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, 003-0804, Japan
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-ku, 162-8655, Japan
Showa University Hospital
Tokyo, 142-8555, Japan
Kanagawa Cancer Center
Yokohama, 241-8515, Japan
Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Sarawak General Hospital
Kuching, 93586, Malaysia
Institut Kanser Negara
Putrajaya, 62250, Malaysia
Centro de Investigacion y Avances Medicos Especializados
Cancún, 77550, Mexico
COI Centro Oncologico Internacional S.A.P.I. de C.V.
Mexico City, 04700, Mexico
FUCAM
México, 4980, Mexico
Hospital Universitario Dr. José Eleuterio González
Monterrey, 64460, Mexico
Clinica Integral Internacional de Oncologia S de RL de CV
Puebla City, 72530, Mexico
Centro Medico Zambrano Hellion
San Pedro Garza García, 64710, Mexico
Centro de Atención e Investigación Clínica en Oncología
Yucatán, 97134, Mexico
Copemicus Podmiot Leczniczy Wojewodzkie Centrum Okologii w Gdansku
Gdansk, 80-219, Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z.o.o
Krakow, 31-826, Poland
Instytut MSF Sp. z o.o.
Lodz, 90-302, Poland
Wojewodzki Szpital Specjalistyczny lm. Stefana Kardynala Wyszynsklego SPZOZ w Lublinie
Lublin, 19713, Poland
LUX MED Onkologia Sp. Zo.o.
Warsaw, 01-748, Poland
Maria Sklodowska - Curie Institute of Oncology
Warsaw, 02-781, Poland
Centro Clinico Academico - Hospital de Braga
Braga, Portugal
Hospital da Senhora da Oliveira Guimaraes
Guimarães, 4835-044, Portugal
Centro Hospitalar de Lisboa Central, E.P.E . - Hospital de Santo Antonio dos Capuchos
Lisbon, 1153-302, Portugal
Fundacao Champalimaud
Lisbon, 1400-038, Portugal
Centro Hospitalar Lisboa Norte, EPE
Lisbon, 1649-035, Portugal
Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano
Matosinhos Municipality, 4464-513, Portugal
National University Hospital
Singapore, 119228, Singapore
National Cancer Centre Singapore
Singapore, 169610, Singapore
Tan Tock Seng Hospital
Singapore, 308433, Singapore
Wilgers Oncology Centre
Gauteng, 0081, South Africa
Wits Clinical Research
Johannesburg, 2192, South Africa
The Medical Oncology Centre of Rosebank
Johannesburg, 2196, South Africa
Cape Town Oncology Trials
Kraaifontein, 7570, South Africa
Samsung Medical Center
Gangnam-Gu, 06351, South Korea
National Cancer Center
Goyang-si Gyeonggi-do, 10408, South Korea
Kyungpook National University Chilgok Hospital
Gyeongsangbuk-do, 41404, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Hospital Universitari Dexeus
Barcelona, 08028, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Universitari Vall D'Hebron
Barcelona, 8035, Spain
Hospital de Basurto
Bilbao, 48013, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital General Universitario De Elche
Elche, 3203, Spain
Hospital Universitario de Jaen
Jaén, 23007, Spain
Hospital Beata María Ana
Madrid, 28007, Spain
Hospital General Universitario Gregorio Marañón
Madrid, 28007, Spain
MD Anderson Cancer Center
Madrid, 28033, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario de Salamanca
Salamanca, 37002, Spain
Hospital Clínico Universitario de Santiago de Compostela - CHUS
Santiago de Compostela, 15706, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital Universitario Virgen Macarena
Seville, 41071, Spain
Instituto Valenciano De Oncologia (IVO)
Valencia, 46009, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301, Taiwan
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei City, 235, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
Chi Mei Hospital, Liouying
Tainan, 73657, Taiwan
National Taiwan University Hospital
Taipei, 10048, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Tri-Service General Hospital
Taipei, 11490, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, 999999, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, 33305, Taiwan
Barts Cancer Institute
London, EC1A 7BE, United Kingdom
University College London Hospitals
London, NW1 2PG, United Kingdom
The Royal Marsden NHS Foundation Trust
London, SW10 9NH, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB, United Kingdom
Related Publications (1)
Tarantino P, Tolaney SM, Curigliano G. Trastuzumab deruxtecan (T-DXd) in HER2-low metastatic breast cancer treatment. Ann Oncol. 2023 Oct;34(10):949-950. doi: 10.1016/j.annonc.2023.07.003. Epub 2023 Jul 26. No abstract available.
PMID: 37499870DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2023
First Posted
May 3, 2023
Study Start
May 8, 2023
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
October 3, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share