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New drug shows promise for Hard-to-Treat breast cancer in major trial

NCT ID NCT03734029

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug, DS-8201a, against standard treatments for people with a specific type of advanced breast cancer called HER2-low. The cancer has spread to other parts of the body and cannot be removed by surgery. About 557 adults whose cancer has already been treated with other therapies will be randomly assigned to receive either DS-8201a or the doctor's choice of standard treatment. The main goal is to see if DS-8201a can delay cancer growth better than current options.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

557 people

The number who actually took part.

Started

Dec 2018

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Is the age of majority in their country * 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: * 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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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • AKH - Medizinische Universität Wien (4305)

    Vienna, 1090, Austria

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, 464-8681, Japan

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499, South Korea

  • Akademiska Sjukhuset

    Uppsala, 75185, Sweden

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001, China

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Athens Medical Center

    Athens, 15125, Greece

  • Azienda Ospedaliera Card. G. Panico

    Tricase, Lecce, 73039, Italy

  • Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico

    Catania, 95125, Italy

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

    Bologna, 40138, Italy

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata

    Roma, 00133, Italy

  • Azienda Ospedaliero Universitaria Mater Domini-Campus Universitario

    Catanzaro, 88100, Italy

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

    Brescia, 25100, Italy

  • Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)

    Monza, Milano, 20900, Italy

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • Baptist Cancer Center

    Memphis, Tennessee, 38120, United States

  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

    Gyula, 5700, Hungary

  • Bioclinic Thessaloniki

    Thessaloniki, 54622, Greece

  • BloomTrials Clinical Research, LLC

    Dallas, Texas, 75234, United States

  • Brig Center for Cancer Care and Survivorship

    Knoxville, Tennessee, 37909, United States

  • CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie

    Plérin, Cotes d'Armor, 22190, France

  • CHU Brest - Hôpital Morvan

    Brest, Finistere, 29609, France

  • CHU UCL Namur

    Namur, 5000, Belgium

  • CRLCC Eugene Marquis

    Rennes, Ille Et Vilaine, 35042, France

  • Cancer Care Associates Medical Group, Inc. TORI

    Redondo Beach, California, 90277, United States

  • Cancer Center of Kansas

    Wichita, Kansas, 67214, United States

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021, China

  • Cancer Institute Hospital of JFCR

    Kōtoku, Tokyo-To, 135-8550, Japan

  • Cancer Treatment Centers of America

    Zion, Illinois, 60099, United States

  • Cancer Treatment Centers of America at Western Regional Medical Center

    Goodyear, Arizona, 85338, United States

  • Cancer Treatment Centers of America-Georgia

    Newnan, Georgia, 30263, United States

  • Centre François Baclesse

    Caen, Calvados, 14076, France

  • Centre Hospitalier Emile Roux

    Le Puy-en-Velay, Loiret, 43012, France

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, 1011, Switzerland

  • Centre Hospitalier Valenciennes

    Valenciennes, Nord, 59322, France

  • Centre Hospitalier Wallonie picarde - Site IMC

    Tournai, 7500, Belgium

  • Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E

    Vila Nova de Gaia, 4434-502, Portugal

  • Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião

    Santa Maria da Feira, 4520-211, Portugal

  • Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria

    Lisbon, 1649-035, Portugal

  • Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE

    Vila Real, 5000-508, Portugal

  • Centro Hospitalar do Alto do Ave, EPE

    Guimarães, 4835-044, Portugal

  • Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António

    Porto, 4099-001, Portugal

  • Chaim Sheba Medical Center

    Ramat Gan, 52363, Israel

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853, China

  • Christiana Care Health Services, Inc.

    Newark, Delaware, 19713, United States

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 361-711, South Korea

  • Clinique Clementville

    Montpellier, Herault, 34070, France

  • Clinique Victor Hugo - Centre Jean Bernard

    Le Mans, Sarthe, 72015, France

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, La Coruña, 15006, Spain

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Debreceni Egyetem

    Debrecen, 4032, Hungary

  • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

    Budapest, 1097, Hungary

  • Eastern Connecticut Hematology/Oncology Assoc.

    Norwich, Connecticut, 06360, United States

  • Euromedica General Clinic Thessaloniki

    Thessaloniki, 54645, Greece

  • FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

    Moscow, 115478, Russia

  • Florida Cancer Specialists (South Region)

    Fort Myers, Florida, 33916, United States

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168, Italy

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 20032, China

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, 960-1295, Japan

  • Fundação Champalimaud

    Lisbon, 1400-038, Portugal

  • Fuzhou General Hospital of Nanjing Military Area Command of Chinese PLA

    Fuzhou, Fujian, 350025, China

  • General Hospital Papageorgiou

    Thessaloniki, 56429, Greece

  • General Hospital of Athens "Alexandra"

    Athens, 11528, Greece

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia Hui, 750004, China

  • General Oncology Hospital of Kifissia " Agioi Anargyroi"

    Athens, 14564, Greece

  • Grand Hôpital de Charleroi

    Loverval, 6280, Belgium

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, 9112001, Israel

  • Hakuaikai Sagara Hospital

    Kagoshima, Kagoshima-ken, 892-0833, Japan

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081, China

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, Hiroshima, 730-8518, Japan

  • Hirslanden Medical Center

    Aarau, 5000, Switzerland

  • Hopital Tenon

    Paris, 75020, France

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29010, Spain

  • Hospital General Universitario de Valencia

    Valencia, 46014, Spain

  • Hospital Quironsalud Barcelona

    Barcelona, 08023, Spain

  • Hospital Ruber Internacional

    Madrid, 28034, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Universitario Donostia

    San Sebastián, Guipuzcoa, 20014, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Tenerife, 38320, Spain

  • Hospital de Basurto

    Bilbao, Vizcaya, 48013, Spain

  • Hospital de Braga

    Braga, 4710-243, Portugal

  • Hospital del Mar

    Barcelona, 08003, Spain

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079, China

  • Hyogo College of Medicine Hospital

    Nishinomiya-shi, Hyōgo, 663-8501, Japan

  • Hôpital Saint-Louis - Paris

    Paris, Paris, 75475, France

  • Hôpital d'Instruction des Armees Begin*

    Saint-Mandé, Val De Marne, 94160, France

  • ICO - Site Paul Papin

    Angers, Maine Et Loire, 49055, France

  • ICO - Site René Gauducheau

    Saint-Herblain, Loire Atlantique, 44805, France

  • ICO l'Hospitalet - Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

  • IEO Istituto Europeo di Oncologia

    Milan, 20141, Italy

  • Inha University Hospital

    Incheon, Gyeonggi-do, 22332, South Korea

  • Institut Bergonié

    Bordeaux, Gironde, 33076, France

  • Institut Curie - site de Paris

    Paris, 75005, France

  • Institut Gustave Roussy

    Villejuif, Val De Marne, 94805, France

  • Institut Jules Bordet

    Brussels, 1000, Belgium

  • Institut Paoli Calmettes

    Marseille, Bouches-du-Rhône, 13009, France

  • Institut Régional du Cancer de Montpellier

    Montpellier, Herault, 34298, France

  • Institut Sainte Catherine

    Avignon, Vaculuse, 84918, France

  • Instituto Português de Oncologia do Porto Francisco Gentil, EPE

    Porto, 4200-072, Portugal

  • Instituto Valenciano de Oncologia IVO

    Valencia, 46009, Spain

  • Interbalkan Hospital of Thessaloniki

    Thessaloniki, 57001, Greece

  • Ironwood Cancer & Research Centers - Chandler II

    Chandler, Arizona, 85224, United States

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089, Italy

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples, 80131, Italy

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

    Szolnok, 5004, Hungary

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012, China

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515, Japan

  • Kantonsspital Graubuenden

    Chur, 7000, Switzerland

  • Kantonsspital St. Gallen

    Sankt Gallen, 9007, Switzerland

  • Kantonsspital Winterthur

    Winterthur, 8401, Switzerland

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807, Taiwan

  • Kaplan Medical Center

    Rehovot, 7610001, Israel

  • Karolinska universitetssjukhuset - Solna

    Solna, 17176, Sweden

  • Kepler Universitätsklinikum

    Linz, 4020, Austria

  • Kindai University Hospital

    Onohigashi, Osakasayama-shi, 589-8511, Japan

  • Klinikum Wels-Grieskirchen GmbH

    Wels, 4600, Austria

  • Klinikum der Universitaet Muenchen - Campus Grosshardern

    Munich, Bavaria, 81377, Germany

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404, South Korea

  • LKH - Universitätsklinikum der PMU Salzburg

    Salzburg, 5020, Austria

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning, 110042, China

  • Linyi Cancer Hospital

    Linyi, Shandong, 276001, China

  • Länssjukhuset Sundsvall-Härnösand

    Sundsvall, 85186, Sweden

  • MD Anderson Cancer Centre

    Madrid, 28033, Spain

  • McGill University - Dept. Oncology Clinical Research Program

    Montreal, Quebec, H2W 1S6, Canada

  • Medizinische Universität Innsbruck

    Innsbruck, 6020, Austria

  • Memorial Healthcare System MRH Cancer Center

    Hollywood, Florida, 33021, United States

  • Memorial Sloan Kettering Hospital

    New York, New York, 10065, United States

  • Moffitt Cancer Center -Tampa

    Tampa, Florida, 33139, United States

  • NHO Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804, Japan

  • NHO Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395, Japan

  • NHO Osaka National Hospital

    Osaka, Osaka, 540-0006, Japan

  • NHO Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280, Japan

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408, South Korea

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • New York University Medical Center

    New York, New York, 10016, United States

  • Nottingham University Hospitals City Campus

    Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Orlando Health, Inc.

    Orlando, Florida, 32806, United States

  • Orszagos Onkologiai Intezet

    Budapest, 1122, Hungary

  • Ospedale Sacro Cuore Don Calabria

    Negrar, Verona, 37024, Italy

  • Ospedale degli Infermi

    Rimini, 47923, Italy

  • Queen Mary University of London

    London, Greater London, EC1M 6BQ, United Kingdom

  • Rabin Medical Center-Beilinson Campus

    Petah Tikva, 49100, Israel

  • Rambam Health Care Center

    Haifa, 3109601, Israel

  • Royal Cornwall Hospital

    Truro, Cornwall, TR1 3LJ, United Kingdom

  • Royal Free Hospital

    London, Greater London, NW3 2QG, United Kingdom

  • Royal Surrey County Hospital

    Guildford, Surrey, GU2 7XX, United Kingdom

  • SBIH of Moscow City "Moscow City Oncology Hospital №62" of Moscow Healthcare Departement

    Moscow, 143423, Russia

  • SBIH of Yaroslavl Region "Regional Clinical Oncological Hospital"

    Yaroslavl, 150054, Russia

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039, United States

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111, United States

  • Saitama Cancer Center

    Kitaadachi-gun, Saitama, 362-0806, Japan

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 120-752, South Korea

  • Shaare Zedek Medical Center

    Jerusalem, 9103102, Israel

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080, China

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka, 411-8777, Japan

  • Showa University Hospital

    Shinagawa-Ku, Tokyo-To, 142-8666, Japan

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

    Hangzhou, Zhejiang, 310016, China

  • St Francis Hospital

    Greenville, South Carolina, 29601, United States

  • Stanford Cancer Institute

    Palo Alto, California, 94305, United States

  • Sun Yat-sen Memorial hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510120, China

  • Sylvester Comprehensive Cancer Center - Deerfield Beach

    Boca Raton, Florida, 33426, United States

  • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

    Nyíregyháza, 4400, Hungary

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906, Israel

  • Tennessee Oncology - Skyline Satellite

    Nashville, Tennessee, 37201, United States

  • The Affiliated Drum Tower Hospital of Nanjing University

    Nanjing, Jiangsu, 210008, China

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591, South Korea

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • The First Hospital of Jilin University

    Changchun, Jilin, 130000, China

  • The Methodist Hospital Research Institute

    Houston, Texas, 77030, United States

  • Tokai University Hospital

    Isehara, Kanagawa, 259-1193, Japan

  • Tom Baker Cancer Center

    Calgary, Alberta, T2N4N2, Canada

  • Toranomon Hospital

    Minatoku, Tokyo-To, 105-8470, Japan

  • Toronto Sunnybrook Hospital

    Toronto, Ontario, M4N 3M5, Canada

  • Touro Infirmary

    New Orleans, Louisiana, 70115, United States

  • UCLA School of Medicine

    Los Angeles, California, 90095, United States

  • UZ Leuven

    Leuven, 3000, Belgium

  • Unidade Local de Saúde de Matosinhos, EPE (Hospital Pedro Hispano)

    Matosinhos Municipality, 4464-509, Portugal

  • Universitaetsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • Universitaetsspital Basel

    Basel, 4031, Switzerland

  • Universitaetsspital Zuerich

    Zurich, 8091, Switzerland

  • Universitair Ziekenhuis Brussel

    Brussels, 1090, Belgium

  • University College London Hospitals

    London, Greater London, NW1 2PG, United Kingdom

  • University General Hospital of Heraklion

    Heraklion, 71110, Greece

  • University General Hospital of Larissa

    Larissa, 41110, Greece

  • University of California at San Francisco (PARENT)

    San Francisco, California, 94158, United States

  • University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • University of Pittsburgh Medical Center Health System

    Pittsburgh, Pennsylvania, 15219, United States

  • University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics

    Houston, Texas, 77030, United States

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

  • Weill Cornell Medicine Breast Center

    New York, New York, 10065, United States

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041, China

  • Western General Hospital

    Edinburgh, Lothian Region, EH4 2XU, United Kingdom

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China

  • Ziv Medical Center

    Safed, 13100, Israel

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