AzTrials
AzTrials

Locally Advanced or Unresectable Metastatic Breast CancerPhase 3ASCENT-07NCT05840211

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

A Phase 3 study testing Sacituzumab Govitecan-hziy, Paclitaxel and Nab-paclitaxel in people with Locally Advanced or Unresectable Metastatic Breast Cancer and Stage IV Breast Cancer, run by Gilead Sciences at 288 sites in 28 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sacituzumab Govitecan-hziy, Paclitaxel and Nab-paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
654 participants
Where
288 sitesin 28 countries
Study dates
8 May 2023to Apr 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Who cannot join

  • 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.
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  • 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.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

288 sites in 28 countries.

288 sites in 28 countries

United States30 sites

  • Investigational Drug Services, AdventHealth Orlando

    Altamonte Springs, Florida, 32701

  • Piedmont Cancer Institute

    Atlanta, Georgia, 30318

  • Georgia Cancer Specialist - Annex

    Atlanta, Georgia, 30341

  • MultiCare Regional Cancer Center - Auburn

    Auburn, Washington, 98001

  • Hematology Oncology Clinic

    Baton Rouge, Louisiana, 70809

  • Florida Cancer Specialists

    Brooksville, Florida, 34613

  • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

    Chandler, Arizona, 85224

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Stefanie Spielman Comprehensive Breast Center

    Columbus, Ohio, 43210

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816

  • US Oncology Investigational Products Center (IPC)

    Fairfax, Virginia, 22031

  • Prisma Health - Upstate

    Greenville, South Carolina, 29605

  • Penn State Cancer Institute

    Hershey, Pennsylvania, 17033

  • The University of Kansas Hospital

    Kansas City, Kansas, 66160

  • Saint Luke's Cancer Institute

    Kansas City, Missouri, 64110

  • Florida Cancer Specialist

    Leesburg, Florida, 34748

  • Rocky Mountain Cancer Centers, LLP

    Littleton, Colorado, 80120

  • Los Angeles Hematology Oncology Medical Group

    Los Angeles, California, 90017

  • Northwest Georgia Oncology Centers

    Marietta, Georgia, 30060

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • Vanderbilt University Medical Center - Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37203

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Yale-New Haven Hospital-Yale Cancer Center

    New Haven, Connecticut, 06510

  • Memorial Sloan-Kettering Cancer Center (MSKCC) - New York

    New York, New York, 10065

  • US Oncology Investigational Products Center (IPC)

    Norfolk, Virginia, 23502

  • Stanford Cancer Institute

    Palo Alto, California, 94305

  • Magee-Womens of UPMC

    Pittsburgh, Pennsylvania, 15213

  • University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94143

  • David C. Pratt Cancer Center

    St Louis, Missouri, 63141

  • Florida Cancer Specialist

    St. Petersburg, Florida, 33705

Other trials in United States

China29 sites

  • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

    Anhui, 230001

  • Peking University People's Hospital

    Beijing, 100044

  • The First Hospital of Jilin University

    Changchun, 130021

  • Xiangya Hospital Central South University

    Changsha, 410008

  • West China Hospital Sichuan University

    Chengdu, 610041

  • Chongqing University Cancer Hospital

    Chongqing, 404100

  • Fujian Cancer Hospital

    Fujian, 350015

  • Fujian Medical University Union Hospital

    Fuzhou, 350001

  • Sun Yat-Sen University Cancer Center

    Guangdong, 510060

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, 510080

  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

    Guangzhou, 510120

  • Sir Run Run Shaw Hospital,Zhejiang University School of Medicine

    Hangzhou, 310000

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

  • Harbin Medical University Cancer Hospital

    Heilongjiang, 150081

  • Jiangsu Province Hospital

    Jiangsu, 210029

  • The First Affiliated Hospital of Soochow University

    Jiangsu, 215004

  • The Nanchang Third Hospital

    Jiangxi, 330009

  • The Second Hospital of Jilin University

    Jilin Sheng, 130041

  • Affiliated Cancer Hospital of Shandong First Medical University

    Jinan, 250117

  • The First Affiliated Hospital of Nanchang University

    Nanchang, 330006

  • General Hospital of Ningxia Medical University

    Ningxia Hui, 750004

  • The Affiliated Hospital Of Qingdao University

    Qingdao, 266071

  • Fudan University Shanghai Cancer Center

    Shanghai, 200030

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, 453000

  • Hubei Cancer Hospital

    Wuhan, 430079

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, 710061

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Zhejiang, 310009

  • Henan Cancer Hospital

    Zhengzhou, 450003

Other trials in China

Japan25 sites

  • Aichi Cancer Center Hospital

    Aichi, 464-8681

  • Tohoku University Hospital

    Aoba-ku, 980-8574

  • Juntendo University Hospital

    Bunkyō City, 113-8431

  • Chiba Cancer Center

    Chiba, 260-8717

  • National Cancer Center Hospital

    Chūōku, 1040045

  • Osaka Prefectural Hospital Organization Osaka International Cancer Institute

    Chūōku, 541-8567

  • National Hospital Organization Shikoku Cancer Center

    Ehime, 791-0280

  • Fukushima Medical University Hospital

    Fukushima

  • Social Medical Corporation Hakuaikai Sagara Hospital

    Kagoshima, 892-0833

  • Tokai University Hospital

    Kanagawa, 259-1193

  • National Cancer Center Hospital East

    Kashiwa, 277-8577

  • Saitama Cancer Center

    Kitaadachi-gun, 362-0806

  • Cancer Institute Hospital of JFCR

    Kōtoku, 135-8550

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • Kyoto University Hospital

    Kyoto, 606-8507

  • National Hospital Organization Kyushu Cancer Center

    Minamiku, 811-1395

  • Nagoya University Hospital

    Nagoya, 466-8560

  • Hiroshima City Hiroshima Citizens Hospital

    Nakaku, 730-8518

  • Hyogo Medical University Hospital

    Nishinomiya-shi, 663-8501

  • Okayama University Hospital

    Okayama, 700-8558

  • Gunma Prefectural Cancer Center

    Ōta-ku, 373-8550

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, 003-0804

  • Center Hospital of the National Center for Global Health and Medicine

    Shinjuku-ku, 162-8655

  • Showa University Hospital

    Tokyo, 142-8555

  • Kanagawa Cancer Center

    Yokohama, 241-8515

Other trials in Japan

Brazil20 sites

  • Hospital Haroldo Juaçaba - Instituto do Câncer do Ceará

    Fortaleza, 60430-230

  • Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias

    Goiânia, 74605-070

  • Oncosite - Centro de Pesquisa Clinica e Oncologia

    Ijuí, 98700-000

  • Catarina Pesquisa Clinica

    Itajaí, 88301-220

  • Oncoclinicas do Brasil Servicos Medicos AS

    Minas Gerais, 30360-680

  • Liga Norte-Rio-Grandense Contra o Câncer

    Natal, 59062-000

  • CIONC-Centro Integrado de Oncologia de Curitiba

    Paraana, 80810050

  • Hospital Erasto Gaertner

    Paraná, 81.520-060

  • IMIP - Instituto de Medicina Integral Professor Fernando Figueira

    Pernambuco, 50070550

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, 90020-090

  • Hospital de Clínicas de Porto Alegre - HCPA

    Porto Alegre, 90035-903

  • HGB - Hospital Giovanni Battista/Mãe de Deus Center

    Porto Alegre, 90110-270

  • Hospital São Lucas da PUCRS

    Porto Alegre, 90610001

  • Instituto Americas

    Rio de Janeiro, 22775-001

  • Clínica de Oncologia de Porto Alegre Ltda - CLINIONCO

    Rio Grande, 90430-090

  • Unidade de PesquisasClinicas em Oncologia - UPCO

    Rio Grande, 96020-080

  • Instituto do Câncer - Hospital São Vicente de Paulo

    Rio Grande, 99010-090

  • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

    Santo André, 09060-650

  • Instituto Hemomed Oncologia e Hematologia

    São Paulo, 01236-030

  • Clinica de pesquisa e centro de estudos em oncologia ginecológica e mamaria

    São Paulo, 1317000

Other trials in Brazil

Spain19 sites

  • Hospital Universitari Dexeus

    Barcelona, 08028

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Universitari Vall D'Hebron

    Barcelona, 8035

  • Hospital de Basurto

    Bilbao, 48013

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital General Universitario De Elche

    Elche, 3203

  • Hospital Universitario de Jaen

    Jaén, 23007

  • Hospital Beata María Ana

    Madrid, 28007

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • MD Anderson Cancer Center

    Madrid, 28033

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario de Salamanca

    Salamanca, 37002

  • Hospital Clínico Universitario de Santiago de Compostela - CHUS

    Santiago de Compostela, 15706

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitario Virgen Macarena

    Seville, 41071

  • Instituto Valenciano De Oncologia (IVO)

    Valencia, 46009

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

Italy17 sites

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

    Ancona AN, 60126

  • Centro di Riferimento Oncologico - IRCCS

    Aviano, 33081

  • Humanitas Gavazzeni

    Bergamo, 24125

  • ASST Papa Giovanni XXIII

    Bergamo, 24127

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola

    Bologna

  • Humanitas Istituto Clinico Catanese

    Catania, 95045

  • Azienda Ospedaliera Mater Domini

    Catanzaro, 88100

  • IRCCS Ospedale Policlinico San Martino

    Genova GE, 16132

  • Istituto Europeo di Oncologia

    Milan, 20141

  • Fondazione IRCCS San Raffaele del Monte Tabor

    Milan, 20132

  • Azienda Ospedaliera San Gerardo

    Monza, 20090

  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

    Naples, 80131

  • Istituto Oncologico Veneto IOV

    Padova, 35128

  • Irccs Crob

    Rionero in Vulture, 85028

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I

    Roma, 161

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 168

  • Istituto Clinico Humanitas

    Rozzano, 20089

Other trials in Italy

France16 sites

  • CHU Jean Minjoz

    Besançon, 25030

  • Institut Bergonié

    Bordeaux, 33076

  • Centre Georges François Leclerc

    Dijon, 21000

  • Centre Oscar Lambret

    Lille, 59000

  • Clinique Francois Chenieux

    Limoges, 87039

  • Ico René Gauducheau

    Loire Atlantique, 44 805

  • Centre Leon Berard

    Lyon, 69373

  • Institut Paoli Calmettes

    Marseille, 13009

  • Institut Regional du Cancer de Montpellier

    Montpellier, 34298

  • Institut Curie

    Paris, 75248

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite, 69310

  • Hopital Privé des Cotes d'Armor

    Plérin, 22190

  • Centre Jean Bernard Service d'Oncologie Médicale

    Rennes, 35042

  • Centre Henri Becquerel

    Rouen

  • Institut Universitaire du Cancer de Toulouse Oncopole

    Toulouse, 31059

  • Institut Gustave Roussy

    Villejuif, 94800

Other trials in France

Germany14 sites

  • Universitaetsklinikum Freiburg, Klinik fuer Frauenheilkunde

    Baden-Württemberg, 79106

  • University Hospital rechts der Isar Technical University of Munich

    Bayern, 81675

  • Vivantes Klinikum am Urban

    Berlin, 10967

  • HELIOS Klinikum Berlin-Buch

    Berlin, 13125

  • Marienhospital Bottrop

    Bottrop, 46236

  • Universitätsklinik Erlangen

    Erlangen, 91054

  • SRH Wald-Klinikum Gera GmbH

    Gera, 07548

  • Universitatsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Medizinische Hochschule Hannover

    Hanover, D-30625

  • Nationales Centrum für Tumorerkrankungen Heidelberg

    Heidelberg, 69120

  • Universitätsklinikum Mannheim

    Mannheim, 68167

  • LMU Klinikum der Universitat München

    München, 81377

  • Universitatsklinikum Munster

    Münster, 48149

  • Universitäts - Frauenklinik

    Tübingen, 72076

Other trials in Germany

Australia10 sites

  • Icon Cancer Centre Wesley

    Auchenflower, Queensland, 4066

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • Icon Cancer Centre Hobart

    Hobart, Tasmania, 7000

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Austin Health

    Melbourne, Victoria, 3084

  • Breast Cancer Research Centre - WA

    Nedlands, Western Australia, 6009

  • Royal Brisbane and Women's Hospital

    Queensland, ME, 4029

  • Sunshine Hospital (Western Health)

    St Albans, Victoria, 3021

  • GenesisCare North Shore (Oncology)

    St Leonards, New South Wales, 2065

Other trials in Australia

Taiwan10 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

  • Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare

    New Taipei City, 235

  • National Cheng Kung University Hospital

    Tainan, 704

  • Chi Mei Hospital, Liouying

    Tainan, 73657

  • National Taiwan University Hospital

    Taipei, 10048

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Tri-Service General Hospital

    Taipei, 11490

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 999999

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan City, 33305

Other trials in Taiwan

South Korea9 sites

  • Samsung Medical Center

    Gangnam-Gu, 06351

  • National Cancer Center

    Goyang-si Gyeonggi-do, 10408

  • Kyungpook National University Chilgok Hospital

    Gyeongsangbuk-do, 41404

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

Argentina7 sites

  • Hospital Britanico de Buenos Aires

    Buenos Aires, 1426

  • Instituto de Investigaciones Clinicas de Mar del Plata

    Buenos Aires, B7600

  • Instituto Alexander Fleming

    C.a.b.a., 1426ANZ

  • Hospital Alemán

    CABA, 1118

  • Centro Privado de RMI Rio Cuarto S.A.

    Córdoba, 5800

  • Instituto de Oncología de Rosario

    Rosario, 2000

  • CER San Juan Centro Polivalente de Asistencia e Investigación Clínica

    San Juan, 5400

Other trials in Argentina

Czechia7 sites

  • Fakultni Nemocnice Brno

    Brno, 62500

  • Masaryk Memorial Cancer Institute

    Brno, 656 53

  • University Hospital Olomouc

    Olomouc, 779 00

  • Multiscan s.r.o

    Pardubice, 532 01

  • Charles General University Hospital, Prague

    Prague, 12808

  • Fakultni nemocnice v Motole

    Prague, 14059

  • Krajska nemocnice Tomase Bati Zlin

    Zlín, 760 01

Other trials in Czechia

Greece7 sites

  • Alexandra General Hospital

    Athens, 11528

  • Attikon Hospital

    Athens, 124 62

  • University Hospital of Heraklion

    Heraklion

  • University Hospital of Larissa

    Larissa, 41110

  • University Hospital of Patras

    Pátrai, 26 500

  • Bioclinic of Thessaloniki

    Thessaloniki, 546 22

  • Euromedica General Clinic of Thessaloniki

    Thessaloniki, 546 45

Other trials in Greece

Mexico7 sites

  • Centro de Investigacion y Avances Medicos Especializados

    Cancún, 77550

  • FUCAM

    México, 4980

  • COI Centro Oncologico Internacional S.A.P.I. de C.V.

    Mexico City, 04700

  • Hospital Universitario Dr. José Eleuterio González

    Monterrey, 64460

  • Clinica Integral Internacional de Oncologia S de RL de CV

    Puebla City, 72530

  • Centro Medico Zambrano Hellion

    San Pedro Garza García, 64710

  • Centro de Atención e Investigación Clínica en Oncología

    Yucatán, 97134

Other trials in Mexico

Israel6 sites

  • Oncology Institute Rambam Health Care Campus

    Haifa, 31096

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Hadassah Medical Center

    Jerusalem

  • Rabin Medical Center

    Petah Tikva, 4941492

  • Sheba Medical Center

    Ramat Gan, 52621

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Poland6 sites

  • Copemicus Podmiot Leczniczy Wojewodzkie Centrum Okologii w Gdansku

    Gdansk, 80-219

  • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z.o.o

    Krakow, 31-826

  • Instytut MSF Sp. z o.o.

    Lodz, 90-302

  • Wojewodzki Szpital Specjalistyczny lm. Stefana Kardynala Wyszynsklego SPZOZ w Lublinie

    Lublin, 19713

  • LUX MED Onkologia Sp. Zo.o.

    Warsaw, 01-748

  • Maria Sklodowska - Curie Institute of Oncology

    Warsaw, 02-781

Other trials in Poland

Portugal6 sites

  • Centro Clinico Academico - Hospital de Braga

    Braga

  • Hospital da Senhora da Oliveira Guimaraes

    Guimarães, 4835-044

  • Centro Hospitalar de Lisboa Central, E.P.E . - Hospital de Santo Antonio dos Capuchos

    Lisbon, 1153-302

  • Fundacao Champalimaud

    Lisbon, 1400-038

  • Centro Hospitalar Lisboa Norte, EPE

    Lisbon, 1649-035

  • Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano

    Matosinhos Municipality, 4464-513

Other trials in Portugal

Belgium5 sites

  • GZA Ziekenhuizen - Campus Sint-Augustinus

    Antwerp, 2610

  • AZ Klina

    Brasschaat, 2930

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitaire Ziekenhuis Leuven

    Leuven, 3000

  • CHU UCL Namur-Site STE. Elisabeth

    Namur, 5000

Other trials in Belgium

Canada5 sites

  • BC Cancer - Kelowna

    Kelowna, V1Y 5L3

  • The Ottawa Hospital Cancer Centre

    Ottawa, K1H 8L6

  • CHU de Québec-Université Laval, Hôpital du Saint-Sacrement

    Québec, G1S 4L8

  • Humber River Hospital

    Toronto, M3M 0B2

  • BC Cancer-Victoria

    Victoria, V8R 6V5

Other trials in Canada

Chile5 sites

  • Centro de Investigacion Clinica Bradford Hill

    Recoleta

  • Centro del Cancer UC

    Region Metropolitana, 7550000

  • Centro de Oncología de Precisión (COP)

    Santiago Region, 8330032

  • James Lind Centro de Investigacion del Cancer

    Temuco

  • Oncocentro APYS

    Viña del Mar, 2520612

Other trials in Chile

Hungary5 sites

  • Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika

    Budapest, 1083

  • Debreceni Egyetem Klinikai Központ

    Debrecen, 4032

  • Bács-Kiskun Varmegyei Oktatokorhaz, Onkaradiologiai Kozpont

    Kecskemét, 6000

  • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz, Onkoradiologia

    Nyíregyháza, 4400

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, 6720

Other trials in Hungary

United Kingdom5 sites

  • Barts Cancer Institute

    London, EC1A 7BE

  • University College London Hospitals

    London, NW1 2PG

  • The Royal Marsden NHS Foundation Trust

    London, SW10 9NH

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB

Other trials in United Kingdom

Austria4 sites

  • University Hospital Innsbruck

    Innsbruck, 06020

  • Universitätsklinik für Innere Medizin 3 der PMU

    Salzburg, A-5020

  • Medizinische Universitat Wien, Univ. Klinik fur Innere Medizin I Klinische Abteilung fur Onkologie

    Vienna, 1090

  • Klinikum Wels-Grieskirchen

    Wels, 4710

Other trials in Austria

Malaysia4 sites

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

  • Sarawak General Hospital

    Kuching, 93586

  • Institut Kanser Negara

    Putrajaya, 62250

Other trials in Malaysia

South Africa4 sites

  • Wilgers Oncology Centre

    Gauteng, 0081

  • Wits Clinical Research

    Johannesburg, 2192

  • The Medical Oncology Centre of Rosebank

    Johannesburg, 2196

  • Cape Town Oncology Trials

    Kraaifontein, 7570

Other trials in South Africa

Hong Kong3 sites

  • Hong Kong Integrated Oncology Centre

    Hong Kong, 0

  • Prince of Wales Hospital

    New Territories

  • Queen Mary Hospital

    Pok Fu Lam, 0

Other trials in Hong Kong

Singapore3 sites

  • National University Hospital

    Singapore, 119228

  • National Cancer Centre Singapore

    Singapore, 169610

  • Tan Tock Seng Hospital

    Singapore, 308433

Other trials in Singapore

About this study

Official title: 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

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).

Being tested
Sacituzumab Govitecan-hziy, Paclitaxel, Nab-paclitaxel, Capecitabine
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacituzumab Govitecan-hziyDrug

    Also called Trodelvy™, GS-0132, IMMU-132

    Administered intravenously

  • PaclitaxelDrug

    Also called Taxol®

    Administered intravenously

  • Nab-paclitaxelDrug

    Also called Abraxane®

    Administered intravenously

  • CapecitabineDrug

    Also called Xeloda®

    Administered orally

Study groups in NCT05840211
Study groupRoleWhat they receive
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.
Receives: Drug: Sacituzumab Govitecan-hziy
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.
Receives: Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to approximately 29 months

Secondary outcomes (9)

  1. Overall Survival (OS)

    OS is defined as the time from randomization until the date of death from any cause.

    Measured: Until death, up to approximately 60 months

  2. Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1

    ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.

    Measured: Until progression, up to approximately 60 months

  3. 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

    The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).

    The Physical Functioning domain includes 5 questions in which participants will be asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 4 (excellent), with a higher score representing a high QoL.

    Measured: Baseline, Week 16

  4. Time to Deterioration in Version 3.0 EORTC-QLQ-C30 Scores

    Time to deterioration from baseline in European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100. For functioning and global health status/QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.

    Measured: Up to approximately 60 months

  5. Progression Free Survival (PFS) as Assessed by Investigator 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) by investigator assessment according to RECIST v1.1 or death from any cause, whichever comes first.

    Measured: Until progression or death, up to approximately 60 months

  6. Objective Response Rate (ORR) as Assessed by Investigator per RECIST Version 1.1

    ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.

    Measured: Up to approximately 60 months

  7. Duration of Response (DOR) as Assessed by BICR and Investigator per RECIST Version 1.1

    DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of objective PD or death from any cause (whichever comes first).

    Measured: Until progression or death, up to approximately 60 months

  8. Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Measured: First dose date up to 30 days post last dose, up to approximately 60 months

  9. Percentage of Participants Experiencing Clinically Significant Laboratory and/or Vital Sign Abnormalities

    Measured: First dose date up to 30 days post last dose, up to approximately 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2023
  2. Study start8 May 2023
  3. Primary completionApr 2028 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
654 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05840211
Sponsor's protocol ID
GS-US-598-6168
Other IDs
2022-502593-17-00, jRCT2061230032, DOH-27-082023-6901, MOH_2023-07-17_012821, CTR20233370
Acronym
ASCENT-07
Status last verified
Sep 2025
First submitted
21 Apr 2023
Last updated
3 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37499870

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sacituzumab Govitecan-hziy, Paclitaxel and Nab-paclitaxel in people with Locally Advanced or Unresectable Metastatic Breast Cancer and Stage IV Breast Cancer, run by Gilead Sciences at 288 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 288 sites in United States, China, Japan, Brazil, Spain and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: Up to approximately 29 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05840211, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.

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