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New hope for Hard-to-Treat breast cancer: drug targets even low HER2 levels

NCT ID NCT05950945

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial is testing trastuzumab deruxtecan (T-DXd), a drug that delivers chemotherapy directly to cancer cells with a specific marker (HER2). It includes 250 people with advanced breast cancer that has low or even no HER2, which is often harder to treat. Participants receive the drug every three weeks, and researchers will track how long it takes before they need a different treatment.

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 (T-DXd, Enhertu)
What this could lead to
If successful, this could provide a new treatment option for people with advanced breast cancer that has low or no HER2 protein, potentially delaying the need for other therapies.
What could go wrong
This is an open-label study without a placebo group, so results may be less definitive. Side effects from T-DXd can include lung inflammation, nausea, and low blood counts.

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

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Oct 2027

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: * Sign and date the main informed consent form * Must agree to provide a newly obtained or archival baseline biopsy from primary and/or metastatic lesion. * Pathologically documented Breast Cancer (BC) tumor * Is unresectable and/or metastatic. * Is hormone receptor-negative or hormone receptor-positive. * Must include percentage of positively stained cells to characterize if hormone receptor-positive or -negative. * Has confirmed HER2 IHC 1+ or IHC 2+/ISH- (HER2-low) status or HER2 IHC 0 status as determined according to ASCO CAP 2018 guidelines1 based on sample collected during Tissue Screening as described above. * Was never previously HER2-positive (IHC 3+ or IHC 2+/ISH+) on prior pathology testing (per ASCO CAP guidelines). * Was never previously treated with anti-HER2 therapy in the metastatic setting. * Has had at least one and up to two prior lines of therapy in the metastatic setting. * In participants with hormone receptor-positive HER2-low metastatic BC (Cohort 3): * Has recurrent disease \<2 years from the initiation of adjuvant ET OR * Has disease progression on CDK4/6 inhibitor-based regimen within 12 months of completion of adjuvant therapy with a CDK4/6 inhibitor OR * Has disease progression within the first 12 months of CDK4/6 in the first line metastatic setting * Presence of at least one measurable lesion based on computed tomography or magnetic resonance imaging. * Participants with brain metastases are allowed in the study. The brain lesion(s) should be small (\<2 cm), untreated, asymptomatic, not requiring urgent medical intervention, and are asymptomatic and clinically stable. * Has an Eastern Cooperative Oncology Group performance status of 0 or 1. * Has a minimum life expectancy of 12 weeks at Screening. * Has a left ventricular ejection fraction ≥50% within 28 days before enrollment. * Has adequate organ and bone marrow function within 28 days before enrollment. * Has adequate treatment washout period before enrollment. * Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception. Exclusion Criteria: * Prior treatment with an antibody drug conjugate (ADC). * Uncontrolled or significant cardiovascular disease. * Has a corrected QT interval prolongation. * Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening. * Has spinal cord compression or clinically active central nervous system metastases. * Has multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, other solid tumors curatively treated, or contralateral BC. * Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product. * Has a history of severe hypersensitivity reactions to other monoclonal antibodies. * Has an uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals. * Active primary immunodeficiency, known uncontrolled active human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection. * Has history of receiving a live, attenuated vaccine (messenger RNA and replication-deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first exposure to study drug. * Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤1 or baseline. * Is pregnant or breastfeeding or planning to become pregnant. * Lung-specific intercurrent clinically significant illnesses. * Any autoimmune, connective tissue, or inflammatory disorders. * Prior complete pneumonectomy.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm

As listed by the trial registrant

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

Breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    68 sites in 9 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • 307 Hospital of PLA

    RECRUITING

    Beijing, 100161, China

  • Alrijne Ziekenhuis Leiden

    RECRUITING

    Leiden, 2334, Netherlands

  • Amphia Ziekenhuis Molengracht

    RECRUITING

    Breda, 4818 CK, Netherlands

  • Amsterdam UMC, Locatie VUMC

    RECRUITING

    Amsterdam, 1081 HV, Netherlands

  • Anhui Provincial Cancer Hospital

    RECRUITING

    Hefei, 230031, China

  • Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi IRCCS

    RECRUITING

    Bologna, 40138, Italy

  • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

    RECRUITING

    Rome, 00161, Italy

  • Beaumont Hospital

    RECRUITING

    Dublin, Dublin 9, Ireland

  • Beijing Hospital

    RECRUITING

    Beijing, 100006, China

  • Bernhoven Uden

    RECRUITING

    Uden, 5406, Netherlands

  • Beth Israel Lahey Health

    WITHDRAWN

    Burlington, Massachusetts, 01805, United States

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

    RECRUITING

    Santo André, 09060-650, Brazil

  • CEPON - Centro de Pesquisas Oncológicas de Santa Catarina

    RECRUITING

    Florianópolis, 88034-000, Brazil

  • CIONC-Centro Integrado de Oncologia de Curitiba

    RECRUITING

    Curitiba, 80810-050, Brazil

  • Catarina Pesquisa Clinica

    RECRUITING

    Santa Catarina, 88301-220, Brazil

  • Centre Hospitalier Universitaire de Liege Sart-Tilman

    WITHDRAWN

    Liège, 4000, Belgium

  • Centro Hospitalar de Lisboa Norte E P E Hospital de Santa Maria

    RECRUITING

    Lisbon, 1649-028, Portugal

  • Centro de Oncologia - Unidade Brasília - Hospital Sírio Libanês

    RECRUITING

    Brasília, 71635-610, Brazil

  • Clinica Universidad de Navarra

    RECRUITING

    Pamplona, 31008, Spain

  • Cliniques Universitaires Saint-Luc

    WITHDRAWN

    Brussels, 1200, Belgium

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

    RECRUITING

    São Paulo, 01317-001, Brazil

  • Complejo Hospitalario Universitario Insular Materno-Infantil

    RECRUITING

    Las Palmas de Gran Canaria, 35016, Spain

  • Complejo Hospitalario Universitario de Santiago

    RECRUITING

    Santiago de Compostela, 15706, Spain

  • Cork University Hospital

    RECRUITING

    Cork, T12 EC8P, Ireland

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Elisabeth TweeSteden Ziekenhuis

    RECRUITING

    Tilburg, 5022 GC, Netherlands

  • Ensino e Terapia de Inovação Clínica AMO-ETICA

    RECRUITING

    Salvador, 41810-570, Brazil

  • Fiona Stanley Hospital

    WITHDRAWN

    Murdoch, 6150, Australia

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    RECRUITING

    Rome, 00168, Italy

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, 200032, China

  • Fujian Cancer Hospital

    RECRUITING

    Fujian, 350011, China

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

    RECRUITING

    São José do Rio Preto, 15090-000, Brazil

  • Fundação Champalimaud

    RECRUITING

    Lisbon, 1400-038, Portugal

  • Fundação Doutor Amaral Carvalho

    RECRUITING

    Jaú, 17.210 - 080, Brazil

  • GZA Ziekenhuizen

    WITHDRAWN

    Antwerp, 2610, Belgium

  • GZA Ziekenhuizen

    RECRUITING

    Wilrijk, 2610, Belgium

  • Galway University Hospital

    WITHDRAWN

    Galway, H91 YR71, Ireland

  • GenesisCare St Andrews Hospital

    TERMINATED

    Adelaide, 5000, Australia

  • Haga Ziekenhuis

    RECRUITING

    The Hague, 2545 AA, Netherlands

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, 450008, China

  • Hospital Arnau de Vilanova de Valencia

    RECRUITING

    Valencia, 46015, Spain

  • Hospital Beata Maria Ana

    RECRUITING

    Madrid, 28007, Spain

  • Hospital Clinico Universitario de Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

    RECRUITING

    Curitiba, 81520-060, Brazil

  • Hospital General Universitario Morales Meseguer

    RECRUITING

    Murcia, 30008, Spain

  • Hospital Nossa Senhora da Conceicao

    RECRUITING

    Rio Grande, 88701-160, Brazil

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Donostia

    WITHDRAWN

    Donostia / San Sebastian, 20014, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    RECRUITING

    Majadahonda, 28222, Spain

  • Hospital Universitario Virgen Macarena

    RECRUITING

    Seville, 41009, Spain

  • Hospital Universitario Virgen de las Nieves

    RECRUITING

    Granada, 18014, Spain

  • Hospital das Clínicas FMRP-USP

    RECRUITING

    Riberão Preto, 14015-010, Brazil

  • Hospital de Braga

    RECRUITING

    Braga, 4710-243, Portugal

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, 08025, Spain

  • Humanitas Istituto Clinico Catanese

    RECRUITING

    Misterbianco, 95045, Italy

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

    RECRUITING

    São Paulo, 01246-000, Brazil

  • ICO l'Hospitalet - Hospital Duran i Reynals

    RECRUITING

    Barcelona, 08908, Spain

  • IOV - Istituto Oncologico Veneto IRCCS

    RECRUITING

    Padova, 35128, Italy

  • Institut Jules Bordet

    RECRUITING

    Anderlecht, 1070, Belgium

  • Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE

    WITHDRAWN

    Lisbon, 1099-023, Portugal

  • Instituto Português de Oncologia do Porto Francisco Gentil, EPE

    WITHDRAWN

    Porto, 4200-072, Portugal

  • Instituto de Cancer de Londrina

    RECRUITING

    Londrina, 86015-520, Brazil

  • Istituto Nazionale Tumori Fondazione G Pascale

    RECRUITING

    Naples, 80131, Italy

  • Istituto Nazionale per la Ricerca sul Cancro di Genova

    RECRUITING

    Genova, 16132, Italy

  • Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari

    WITHDRAWN

    Bari, 70124, Italy

  • Jiangxi Cancer Hospital

    RECRUITING

    Nanchang, 330029, China

  • Maastricht University Medical Center

    RECRUITING

    Maastricht, 6229 HX, Netherlands

  • Mater Hospital Sydney

    TERMINATED

    North Sydney, New South Wales, 2065, Australia

  • Medisch Centrum Leeuwarden

    RECRUITING

    Leeuwarden, 8934 AD, Netherlands

  • Monash Medical Centre Moorabbin

    TERMINATED

    East Bentleigh, Victoria, 3165, Australia

  • Mount Sinai Medical Center

    TERMINATED

    Miami Beach, Florida, 33140, United States

  • Nanchang People's Hospital

    RECRUITING

    Nanchang, 330006, China

  • Nuovo Ospedale di Prato

    RECRUITING

    Prato, 59100, Italy

  • Oncosite - Centro de Pesquisa Clinica e Oncologia

    RECRUITING

    Ijuí, 98700-000, Brazil

  • Ospedale San Raffaele

    RECRUITING

    Milan, 20132, Italy

  • Ospedale Santa Chiara

    RECRUITING

    Trento, 38123, Italy

  • Overlook Medical Center

    RECRUITING

    Summit, New Jersey, 07901, United States

  • Shandong Cancer Hospital

    RECRUITING

    Jinan, 250117, China

  • St James Hospital

    RECRUITING

    Dublin, D08 NHY1, Ireland

  • St Vincent's University Hospital

    RECRUITING

    Dublin, D04 T6F4, Ireland

  • Sun Yat sen University Cancer Center

    RECRUITING

    Guangzhou, 510060, China

  • The Affiliated Hospital of Qingdao University

    WITHDRAWN

    Qingdao, 266000, China

  • USF College of Medicine

    WITHDRAWN

    Tampa, Florida, 33602, United States

  • UZ Leuven

    WITHDRAWN

    Leuven, 3000, Belgium

  • Universitair Ziekenhuis Brussel

    WITHDRAWN

    Brussels, 1090, Belgium

  • Xijing Hospital (The First Affiliated Hospital of the Air Force Medical University)

    WITHDRAWN

    Xi'an, 710032, China

  • Yunnan Cancer Hospital

    WITHDRAWN

    Kunming, 650107, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, 310022, China

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