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New drug DS-8201a takes on standard therapy in advanced breast cancer trial

NCT ID NCT03529110

Disease control Sponsor: Daiichi Sankyo Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether the experimental drug DS-8201a (trastuzumab deruxtecan) works better than the current standard T-DM1 for people with HER2-positive breast cancer that cannot be removed by surgery or has spread to other parts of the body. About 524 adults who have already received trastuzumab and a taxane chemotherapy are randomly assigned to one of the two treatments. The main goal is to see how long the cancer stays under control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Trastuzumab deruxtecan (DS-8201a)
What this could lead to
If successful, this could offer a more effective treatment option for people with HER2-positive breast cancer that has spread, potentially slowing disease progression better than the current standard therapy.
What could go wrong
This is a late-stage trial, but results are not yet final. The new drug may not prove superior or could have unexpected side effects. Individual responses vary, and it is not a cure.

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

524 people

The number who actually took part.

Started

Aug 2018

Expected to finish

Jul 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: 1. Must be competent and able to comprehend, sign, and date an Institutional Review Board (IRB) or Ethics Committee (EC) approved ICF before performance of any study-specific procedures or tests. 2. Adults ≥18 y old. (Please follow local regulatory requirements if the legal age of consent for study participation is \>18 y old.) 3. Pathologically documented breast cancer that: 1. is unresectable or metastatic. 2. has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory.23 3. was previously treated with trastuzumab and taxane in the advanced/ metastatic setting or progressed within 6 mo after neoadjuvant or adjuvant treatment involving a regimen including trastuzumab and taxane. 4. Documented radiologic progression (during or after most recent treatment or within 6 mo after completing adjuvant therapy). 5. Subjects must be HER2-positive as confirmed by central laboratory assessment of most recent tumor tissue sample available. If archived tissue is not available, a fresh biopsy is required. 6. Presence of at least 1 measurable lesion per modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1 Exclusion Criteria: 1. Prior treatment with an anti-HER2 ADC (such as T-DM1) in the metastatic setting. Prior treatment in the adjuvant/neoadjuvant setting would be allowed if progression of disease did not occur within 12 mo of end of adjuvant therapy. 2. Uncontrolled or significant cardiovascular disease, including any of the following: 1. History of myocardial infarction within 6 mo before randomization; 2. History of symptomatic congestive heart failure (New York Heart Association Class II to IV); 3. Troponin levels consistent with myocardial infarction as defined according to the manufacturer within 28 d prior to randomization; 4. Corrected QT interval (QTc) prolongation to \> 470 ms (females) or \>450 ms (male) based on average of Screening triplicate 12-lead ECG; 5. LVEF \< 50% within 28 d prior to randomization 3. Has a history of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening. 4. Spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated or symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. * Subjects with clinically inactive brain metastases may be included in the study. * Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 wk must have elapsed between the end of whole brain radiotherapy and study enrollment. 5. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product. 6. History of severe hypersensitivity reactions to other mAbs.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma

As listed by the trial registrant

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

Breast cancer

Contacts and locations

Locations

  • A. C. Camargo Cancer Center

    São Paulo, 01509-900, Brazil

  • A.O.U. Policlinico di Modena

    Modena, 41124, Italy

  • AZ Sint-Lucas - Campus Sint-Lucas

    Ghent, 9000, Belgium

  • Aberdeen Royal Infirmary

    Aberdeen, Grampian Region, AB25 2ZB, United Kingdom

  • Aichi Cancer Center Hospital

    Aichi, 464-8681, Japan

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Azienda Ospealiera della Provincia di Lecco

    Lecco, 23900, Italy

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino, 10126, Italy

  • Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte

    Messina, 98158, Italy

  • Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

    Cona, Ferrara, 44124, Italy

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

    Bologna, 40138, Italy

  • Azienda Ospedaliero Universitaria di Parma

    Parma, 43100, Italy

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

    Bergamo, 24127, Italy

  • Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo), U.O Oncologia Medica

    Monza, Milano, 20900, Italy

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730, China

  • Box Hill Hospital

    Box Hill, Victoria, 3128, Australia

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

    Plérin, Cotes d'Armor, 22190, France

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

    Santo André, São Paulo, 09060-650, Brazil

  • CHRU Jean Minjoz

    Besançon, Doubs, 25030, France

  • CHU UCL Namur site de Sainte Elisabeth

    Namur, 5000, Belgium

  • CRLCC Eugene Marquis

    Rennes, Ille Et Vilaine, 35042, France

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021, China

  • Catarina Pesquisa Clinica

    Itajaí, Santa Catarina, 88301-220, Brazil

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

    Shinjuku-Ku, Tokyo-To, 162-8655, Japan

  • Centre François Baclesse

    Caen, Calvados, 14076, France

  • Centre Georges François Leclerc

    Dijon, Côte-d'Or, 21079, France

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, Rhone, 69495, France

  • Centre Leon Berard

    Lyon, Rhone, 69373, France

  • Centre Paul Strauss

    Strasbourg, Bas Rhin, 67000, France

  • Centre René Huguenin

    Saint-Cloud, Hauts De Seine, 92110, France

  • Centre de cancerologie les Dentellieres

    Valenciennes, Nord, 59300, France

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Clinique Victor Hugo - Centre Jean Bernard

    Le Mans, Cedex 02, Sarthe, 72015, France

  • Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda.

    São Paulo, São Paulo, 01317-001, Brazil

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, La Coruña, 15006, Spain

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, La Coruña, 15706, Spain

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dayton Physicians, LLC

    Kettering, Ohio, 45409, United States

  • Florida Cancer Specialists NORTH

    St. Petersburg, Florida, 33705, United States

  • Florida Cancer Specialists-Broadway

    Fort Myers, Florida, 33916, United States

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100, Italy

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032, China

  • Guy's Hospital

    London, Greater London, SE1 9RY, United Kingdom

  • Haematologisch-Onkologische Schwerpunktpraxis

    Troisdorf, North Rhine-Westphalia, 53840, Germany

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081, China

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, 730-8518, Japan

  • 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 Gregorio Maranon

    Madrid, 28007, Spain

  • Hospital Infanta Cristina

    Badajoz, 6007, Spain

  • Hospital Nossa Senhora da Conceição

    Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen Macarena

    Seville, Sevill, 41009, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Tenerife, 38320, Spain

  • Houston Methodist Hospital / Houston Methodist Cancer Center

    Houston, Texas, 77030, United States

  • Hôpital Nord - CHU Marseille

    Marseille, Bouches-du-Rhone, 13915, France

  • Hôpital Saint-Louis

    Paris, 75010, France

  • Hôpital d'Instruction des Armees Begin

    Saint-Mandé, Val De Marne, 94160, France

  • ICESP - Instituto do Cancer do Estado de São Paulo Octavio Frias de Oliveira

    São Paulo, São Paulo, 01246-000, Brazil

  • ICM Val d'Aurelle

    Montpellier, Herault, 34298, 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

  • IOB-Institute of Oncology

    Barcelona, 8023, Spain

  • IRCCS Centro di Riferimento Oncologico

    Aviano, Pordenone, 33081, Italy

  • Innovative Clinical Research Institute

    Whittier, California, 90603, United States

  • 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 Sainte Catherine

    Avignon, Vaculuse, 84918, France

  • Instituto Americas

    Rio de Janeiro, 22793-080, Brazil

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089, Italy

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples, 80131, Italy

  • Istituto Nazionale per la Ricerca sul Cancro di Genova

    Genova, 16132, Italy

  • Kanagawa Cancer Center

    Kanagawa, 241-8515, Japan

  • Klinikum rechts der Isar der TU Muenchen

    Munich, Bavaria, 81675, Germany

  • Koo Foundation, Sun Yat-Sen Cancer Center

    Taipei, 112, Taiwan

  • Kumamoto University Hospital

    Kumamoto, 860-8556, Japan

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning, 110042, China

  • Loyola University Health System

    Maywood, Illinois, 60153, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • MD Anderson Cancer Centre

    Madrid, 28033, Spain

  • Magee-Womens Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213, United States

  • Marienhospital Bottrop gGmbH

    Bottrop, Rhineland-Palatinate, 46236, Germany

  • Millennium Oncology

    Houston, Texas, 77090, United States

  • MultiCare Health System Institute for Research and Innovation

    Auburn, Washington, 98001, United States

  • NHO Hokkaido Cancer Center

    Hokkaido, 003-0804, Japan

  • NHO Kyushu Cancer Center

    Fukuoka, 811-1395, Japan

  • NHO Osaka National Hospital

    Osaka, 540-0006, Japan

  • NHO Shikoku Cancer Center

    Ehime, 791-0280, Japan

  • NOB - Nucleo de Oncologia da Bahia

    Salvador, Estado de Bahia, 40170-110, Brazil

  • National Cancer Center Hospital

    Tokyo, 104-0045, Japan

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • Niigata Cancer Center

    Niigata, 951-8566, Japan

  • North Shore Hematology Oncology Associates, PC

    East Setauket, New York, 11733, United States

  • Norton Cancer Institute

    Louisville, Kentucky, 40207, United States

  • Nottingham University Hospitals City Campus

    Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

  • Okayama University Hospital

    Okayama, 700-8558, Japan

  • Osaka International Cancer Institute

    Osaka, 541-8567, Japan

  • Ospedale San Raffaele

    Milan, 20132, Italy

  • Peninsula and South Eastern Haematology & Oncology Group

    Frankston, Victoria, 3199, Australia

  • Peter MacCallum Cancer

    Melbourne, Victoria, 3000, Australia

  • Piedmont Cancer Institute, PC

    Atlanta, Georgia, 30318, United States

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Queen Mary University of London

    London, Greater London, EC1M 6BQ, United Kingdom

  • Rotkreuzklinikum Muenchen gGmbH

    Munich, Bavaria, 80637, Germany

  • Royal Devon and Exeter Hospital (Wonford)

    Exeter, Devon, EX2 5DW, United Kingdom

  • Royal Surrey County Hospital

    Guildford, Surrey, GU2 7XX, United Kingdom

  • Saitama Cancer Center

    Saitama, 362-0806, Japan

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Sarah Cannon Research Institute UK

    London, Greater London, W1G 6AD, United Kingdom

  • Seidman Cancer Center

    Cleveland, Ohio, 44106, United States

  • Seoul National University Bundang Hospital

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

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University

    Seoul, 03722, South Korea

  • Sharp Memorial Hospital

    San Diego, California, 92123, United States

  • Shizuoka Cancer Center

    Shizuoka, 411-8777, Japan

  • Showa University Hospital

    Tokyo, 142-8666, Japan

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

    Hangzhou, Zhejiang, 310000, China

  • St John of God Subiaco Hospital

    Subiaco, Western Australia, 6008, Australia

  • St. Mary's Hospital

    Montreal, Quebec, H3T 1M5, Canada

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

    Guangzhou, Guangdong, 510120, China

  • Sun Yat-sen University, Cancer Center

    Guangzhou, Guangdong, 510060, China

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Tennessee Oncology- St Thomas Location

    Nashville, Tennessee, 37205, United States

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550, Japan

  • The Chinese

    Hong Kong, 00000, Hong Kong

  • The Christie Hospital

    Manchester, Greater Manchester, M20 4BX, United Kingdom

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • The Tweed Hospital

    Tweed Heads, New South Wales, 2485, Australia

  • The University of Hong Kong

    Shatin, 00000, Hong Kong

  • The University of Texas Health Science Center at Tyler

    Tyler, Texas, 75708, United States

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060, China

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2, Canada

  • Toronto Sunnybrook Hospital

    Toronto, Ontario, M4N 3M5, Canada

  • UCLA Hematology Oncology

    Los Angeles, California, 90095, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Universitaetsklinikum Duesseldorf AoeR

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

  • Universitaetsklinikum Erlangen

    Erlangen, Bavaria, 91-54, Germany

  • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

    Lübeck, Schleswig-Holstein, 23538, Germany

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650, Belgium

  • Universitair Ziekenhuis Brussel

    Brussels, 1090, Belgium

  • Universitaire Ziekenhuizen Leuven

    Leuven, 3000, Belgium

  • University College London Hospitals

    London, Greater London, NW1 2PG, United Kingdom

  • University of California San Francisco

    San Francisco, California, 94115, United States

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • Vanderbilt Breast Center at One Hundred Oaks

    Nashville, Tennessee, 37232, United States

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157, United States

  • Washington Cancer Institute

    Washington D.C., District of Columbia, 20010, 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

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