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New drug shows promise for Hard-to-Treat breast cancer subtype

NCT ID NCT06486883

Disease control Sponsor: MedSIR 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study tests a drug called trastuzumab deruxtecan (T-DXd) against the usual treatment (a CDK4/6 inhibitor plus hormone therapy) for people with a certain type of advanced breast cancer. The cancer must be hormone receptor-positive, HER2-low or ultralow, and have a specific gene pattern called non-luminal. About 200 participants will be randomly assigned to one of the two treatments to see which works better at delaying cancer growth.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 200 people

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

Started

Jun 2025

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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. Patients must be capable to understand the purpose of the study and have signed written informed consent form (ICF) prior to beginning specific protocol procedures. 2. Female or male patients ≥ 18 years of age at the time of signing ICF. 3. ECOG performance status of 0-1. 4. Minimum life expectancy of ≥ 12 weeks at screening. 5. Evidence of HER2-low expression (1+ by immunohistochemistry (IHC) or 2+ and negative by an in situ hybridization \[ISH\] test) or HER2-ultralow (IHC 0 with faint membrane staining and in ≤ 10% of tumor cells) breast cancer according to the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines determined by a MEDSIR's designated central laboratory, using Ventana 4B5 antibody. This assessment has to be done on the most recently available (archived or newly collected) formalin-fixed, paraffin-embedded (FFPE) tumor tissue blocks (≤ 6 weeks or FFPE of a tumor sample obtained after last prior systemic therapy) from core or excisional biopsy from a locally recurrent (breast or locoregional lymph nodes) or metastatic tumor lesion, excluding bone metastases. 6. Non-luminal breast cancer subtype as per central PAM50 analysis determined in the most recently available (archived or newly collected) FFPE tumor tissue blocks (≤ 6 weeks or FFPE of a tumor sample obtained after last prior systemic therapy) from core or excisional biopsy from a locally recurrent (breast or locoregional lymph nodes) or metastatic tumor lesion with the exception of bone metastases. 7. Patients must have HR-positive (estrogen receptor \[ER\] and/or progesterone receptor \[PgR\]-positive defined as ≥ 1% positive stained cells) status according to the most recent ASCO/CAP guidelines locally determined prior to study entry. 8. Unresectable locally recurrent or metastatic breast cancer documented by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent. 9. Evaluable disease according to RECIST v.1.1. Patients with bone-only disease are not allowed. Patients with bone metastases with soft tissue masses measuring \> 10 mm are eligible. 10. Patients must have endocrine resistance criteria: • disease progression during adjuvant ET or within the first year of completing adjuvant ET; or endocrine sensitivity criteria: • de novo metastatic disease or disease progression ≥ 12 months after completing adjuvant ET with at least one of the following requirements: * Estrogen receptor ≤ 50% positive stained cells; * and/or high histological grade or Ki67 \> 50% on primary tumor; * and/or liver metastases; * and/or known non-luminal subtype as per local PAM50 analysis. 11. No prior treatment with any systemic therapy for advanced disease. 12. Patients treated with a CDK4/6i in the adjuvant setting with a treatment-free interval (TFI) ≥ 12 months following CDK4/6i treatment completion are eligible. 13. Patients have adequate bone marrow, liver, and renal function: * Hematological (without platelet, red blood cell transfusion, and/or granulocyte colony-stimulating factor support within 14 days before first study treatment dose): White blood cell (WBC) count \> 3.0 x 109/L, absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 100.0 x 109/L, and hemoglobin ≥ 9.0 g/dL (≥ 5.6mmol/L). * Hepatic: Serum albumin ≥ 2.5 g/dL; total bilirubin ≤ 1.5 times upper limit of normal (x ULN) (≤ 3 x ULN in patients with liver metastases or know history of Gilbert's disease); alkaline phosphatase (ALP) ≤ 2.5 x ULN (≤ 5 x ULN in patients with liver/or bone metastases); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN (≤ 5 x ULN in patients with liver metastases). * Renal: Creatinine clearance ≥ 30 mL/min as determined by Cockcroft Gault (using actual body weight). * Coagulation: International normalized ratio or prothrombin time and either partial thromboplastin or activated partial thromboplastin time ≤ 1.5 × ULN. 14. Resolution of all acute toxic effects of prior anti-cancer therapy to Grade ≤ 1 as determined by the US National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v.5.0) (except for alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion). 15. Women of childbearing potential who are sexually active with a non-sterilized male partner must have a negative serum pregnancy test within 14 days before study treatment initiation. In addition, they must agree to use one highly effective method of birth control from the time of screening until 7 months after the last dose of T-DXd, or within the time period specified per local prescribing guidelines after the final dose of physician's choice of CDK4/6i plus ET. Female patients must refrain from egg cell donation and breastfeeding during this same period. 16. Male participants who are sexually active with a female partner of childbearing potential must be surgically sterile or using an acceptable method of contraception from the time of screening until 4 months after the last dose of T-DXd, or within the time period specified per local prescribing guidelines after the final dose of physician's choice of CDK4/6i plus ET. Male participants must not donate or bank sperm during this same period. 17. Patients must be accessible for treatment and follow-up. Exclusion Criteria: 1. Current participation in another therapeutic clinical trial, except other translational studies. 2. Treatment with approved or investigational cancer therapy within 3 weeks prior to initiation of study drug. 3. Treatment with chloroquine/hydroxychloroquine within 14 days prior to initiation of study drug. 4. Have previously been treated with T-DXd and/or fulvestrant. Note: patients who experienced relapse after more than 1 year from completion of fulvestrant are eligible. Note I: previous treatment with anti-HER2 therapies in (neo-) adjuvant setting will be allowed for participants who showed conversion from HER2-positive expression in primary breast tumor sample to HER2-low or HER2-ultralow expression (HER2 loss) in relapsed tumor sample. 5. Patients with advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions \[pleural, pericardial, and/or peritoneal\] and pulmonary lymphangitis). 6. Impairment of gastro-intestinal (GI) function or GI disease that may significantly alter the absorption of CDK4/6i, such as history of GI surgery which may result in intestinal blind loops and patients with clinically significant gastroparesis, short bowel syndrome, unresolved nausea, vomiting, active inflammatory bowel disease, or diarrhea of CTCAE Grade \> 1. 7. Known central nervous system (CNS) involvement (brain metastases and/or leptomeningeal carcinomatosis). 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. 8. Have a concurrent malignancy or malignancy within 5 years of study enrollment with the exception of carcinoma in situ of the cervix and basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent. For other cancers considered to have a low risk of recurrence, discussion with the Sponsor's Medical Monitor is required. 9. Known allergy or hypersensitivity reaction to any of the investigational medicinal products (IMPs) or their inactive ingredients. 10. Palliative radiotherapy with a limited field of radiation within 2 weeks or with wide field of radiation or to more than 30% of the bone marrow within 4 weeks prior to start of study treatment. 11. Major surgical procedure or significant traumatic injury within 4 weeks before the first dose of study treatment or anticipation of need for major surgery within the course of the study treatment. 12. Has an active cardiac disease or a history of cardiac dysfunction or conduction abnormalities including, but not confined, to any of the following: * Participants with a medical history of myocardial infarction within 6 months before screening, symptomatic congestive heart failure (NYHA Class II to IV), unstable angina pectoris, or a recent (\< 6 months) cardiovascular event including stroke. Participants with troponin levels above ULN at screening (as defined by the manufacturer), and without any myocardial related symptoms, should have a cardiologic consultation to rule out myocardial infarction. * Left ventricular ejection fraction (LVEF) \< 55% as determined by multigated acquisition (MUGA) scan or echocardiogram (ECHO). * History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, or ventricular tachycardia), which is symptomatic or requires treatment (NCI-CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers will be permitted to enroll. * QT interval corrected by Fridericia's formula (QTcF) prolongation to \> 470 ms (females) or \> 450 ms (males) based on average of the screening triplicate 12-lead electrocardiogram (ECG). * History of QT prolongation associated with other medications that required discontinuation of that medication, or any current concomitant medication known to prolong the QT interval and cause Torsades de Pointes. * Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives. 13. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months of the study enrolment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, post COVID-19 pulmonary fibrosis, etc.), and any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or prior pneumonectomy (complete). 14. Has a history of non-infectious interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. 15. Pregnant or lactating women or patients not willing to apply highly effective contraception as defined in the protocol. 16. Current known infection with hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection (defined as having a negative hepatitis B surface antigen \[HBsAg\] test and a positive hepatitis B core antibody \[HBcAb\] test, accompanied by a negative HBV DNA test), and \> 6 months off anti-viral treatment are eligible. Those participants should be closely monitored for HBV reactivation and have access to a local hepatitis B expert during and after the study. 17. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA. 18. Patients with HCV co-infection or history of HCV co-infection. 19. Patients with cirrhosis or fibrosis on prior imaging or biopsy. 20. Has an active primary immunodeficiency or known human immunodeficiency virus (HIV) infection. 21. Other active uncontrolled infection at the time of enrollment. 22. Receipt of live or attenuated vaccine within 30 days prior to the first dose of study treatment. 23. A history of uncontrolled seizures, CNS disorders, or serious and/or unstable pre-existing psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs or interfering with subject safety. 24. Current use of food or drugs known to be potent CYP3A4 inhibitors, drugs known to be potent CYP3A4 inducers (for examples, see the Prohibited Medications Section). 25. Known substance abuse or any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, contraindicate patient participation. 26. Inability or unwillingness to comply with the requirements of the protocol in the opinion of the investigator.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma hormone receptor-positive breast cancer

As listed by the trial registrant

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

Advanced breast cancer Advanced breast carcinoma Hormone receptor-positive breast carcinoma

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

    79 sites in 10 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

  • A.O.U. Ospedali Riuniti di Ancona

    RECRUITING

    Ancona, 60126, Italy

  • AOU Careggi

    RECRUITING

    Florence, 50134, Italy

  • AOU policlinico di Modena

    RECRUITING

    Modena, Italy

  • Algemeen Ziekenhuis Klina

    RECRUITING

    Brasschaat, Belgium

  • Azienda Ospedaliero- Universitaria Maggiore Della Carita

    RECRUITING

    Novara, 28100, Italy

  • Barts Health NHS Trust

    RECRUITING

    London, United Kingdom

  • CHU Helora - Hopital de Mons

    RECRUITING

    Mons, Belgium

  • CHU Lyon Sud

    RECRUITING

    Lyon, France

  • CHU Saint Etienne

    RECRUITING

    Saint-Priest-en-Jarez, 42055, France

  • Centre Francois Baclesse

    RECRUITING

    Caen, France

  • Centro Oncológico de Galicia

    RECRUITING

    A Coruña, 15009, Spain

  • Centro di Riferimento Oncologico di Aviano

    RECRUITING

    Aviano, 33081, Italy

  • Cliniques universitaires Saint-Luc

    RECRUITING

    Woluwe-Saint-Lambert, Belgium

  • Complejo Hospitalario Universitario A Coruña (CHUAC)

    RECRUITING

    A Coruña, 15006, Spain

  • Complejo Hospitalario Universitario de Santiago (CHUS)

    RECRUITING

    Santiago de Compostela, 15706, Spain

  • Complejo Hospitalario de Jaén

    RECRUITING

    Jaén, Jaén, 23007, Spain

  • Federico II Napoli

    RECRUITING

    Naples, 80131, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli

    RECRUITING

    Roma, 00168, Italy

  • Ghent University Hospital

    RECRUITING

    Ghent, Belgium

  • Hospital Arnau de Vilanova de Valencia

    RECRUITING

    Valencia, Spain

  • Hospital Beata María Ana

    RECRUITING

    Madrid, 28007, Spain

  • Hospital Beatriz Ângelo

    RECRUITING

    Loures, Portugal

  • Hospital Clínic i Provincial de Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital Clínico San Carlos

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Clínico Universitario Lozano Blesa

    RECRUITING

    Zaragoza, 50009, Spain

  • Hospital Clínico Universitario Virgen de la Arrixaca

    RECRUITING

    Murcia, Murcia, 30120, Spain

  • Hospital Clínico Universitario de Valencia

    RECRUITING

    Valencia, Valencia, 46010, Spain

  • Hospital Da Luz Lisboa

    RECRUITING

    Lisbon, Portugal

  • Hospital Gregorio Marañón

    RECRUITING

    Madrid, Spain

  • Hospital QuirónSalud Zaragoza

    RECRUITING

    Zaragoza, 50012, Spain

  • Hospital Quirónsalud Sagrado Corazón

    RECRUITING

    Barcelona, Barcelona, 41013, Spain

  • Hospital San Pedro de Alcántara

    RECRUITING

    Cáceres, Cáceres, 1003, Spain

  • Hospital Universitari Dexeus

    RECRUITING

    Barcelona, 08028, Spain

  • Hospital Universitari Sant Joan de Reus

    RECRUITING

    Reus, Tarragona, 43204, Spain

  • Hospital Universitari i Politècnic La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario Arnau de Vilanova de Lleida

    RECRUITING

    Lleida, 25198, Spain

  • Hospital Universitario Clínico San Cecilio

    RECRUITING

    Granada, Granada, 18007, Spain

  • Hospital Universitario Doce de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    RECRUITING

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Ramón y Cajal

    RECRUITING

    Madrid, Madrid, 28034, Spain

  • Hospital Universitario San Juan de Alicante

    RECRUITING

    Alicante, 03550, Spain

  • Hospital Universitario Virgen Macarena

    RECRUITING

    Seville, 41009, Spain

  • Hospital Universitario Virgen de la Victoria

    RECRUITING

    Málaga, 29010, Spain

  • Hospital Universitario de Basurto

    RECRUITING

    Bilbao, 48013, Spain

  • Hospital de Cascais

    RECRUITING

    Alcabideche, 2755-009, Portugal

  • Hämatologie-Onkologie im Zentrum MVZ

    RECRUITING

    Augsburg, Germany

  • Institut Català d' Oncologia Badalona (ICO)

    RECRUITING

    Badalona, 08916, Spain

  • Institut Català d' Oncologia Girona (ICO)

    RECRUITING

    Girona, Girona, 17007, Spain

  • Institut Curie

    RECRUITING

    Paris, France

  • Institute Paoli Calmettes

    RECRUITING

    Marseille, France

  • Instituto Europeo di Oncologia

    RECRUITING

    Milan, 20141, Italy

  • Instituto Portugues Oncologia de Porto (IPO)

    RECRUITING

    Porto, Portugal

  • Instituto Valenciano de Oncología (IVO)

    RECRUITING

    Valencia, 46009, Spain

  • Istituto Nazionale Tumori Irccs "Fondazione G Pascale"

    RECRUITING

    Naples, 80131, Italy

  • Istituto Oncologico Veneto

    RECRUITING

    Padova, Italy

  • Kepler Universitäts Klinikum

    RECRUITING

    Linz, Austria

  • Kliniken Essen Mitte

    RECRUITING

    Essen, Germany

  • Klinikum Worms - Frauenklinik

    RECRUITING

    Worms, 67550, Germany

  • MVZ Klinikum Aschaffenburg

    RECRUITING

    Aschaffenburg, Germany

  • Medical University of Vienna

    RECRUITING

    Vienna, Austria

  • Medizinische Universität Graz

    RECRUITING

    Graz, Austria

  • Medtrials Sp. z o.o.

    RECRUITING

    Krakow, Poland

  • Netherlands Cancer Institute

    RECRUITING

    Amsterdam, Netherlands

  • Oncologia medica AUSL Piacenza

    RECRUITING

    Piacenza, 29100, Italy

  • Ospedale Policlinico San Martino

    RECRUITING

    Genova, 16132, Italy

  • Ospedale Sacro Cuore Don Calabria Negrar

    RECRUITING

    Negrar, Italy

  • Ospedale San Gerardo

    RECRUITING

    Monza, 20900, Italy

  • Ospedale di Macerata

    RECRUITING

    Province of Macerata, 62100, Italy

  • Royal United Hospitals Bath NHS Foundation Trust

    RECRUITING

    Bath, United Kingdom

  • The Christie NHS Foundation Trust

    RECRUITING

    Lancaster, United Kingdom

  • UOMI Cancer Center

    RECRUITING

    Barcelona, 08017, Spain

  • Unidade Local de Saúde Amadora/Sintra - Hospital Fernando da Fonseca

    RECRUITING

    Amadora, 2720-276, Portugal

  • Unidade Local de Saúde da Região de Aveiro

    RECRUITING

    Aveiro, Portugal

  • Unidade Local de Saúde de Santa Maria

    RECRUITING

    Lisbon, 1649-035, Portugal

  • Unidade Local de Saúde de Santo António

    RECRUITING

    Porto, Portugal

  • Unidade Local de Saúde de Trás-os-Montes e Alto Douro

    RECRUITING

    Lordelo, Vila Real District, 5000-508, Portugal

  • Unidade Local de Saúde do Alto Ave

    RECRUITING

    Braga, Portugal

  • Universitätsklinikum Carl Gustav Carus Dresden

    RECRUITING

    Dresden, Germany

  • Wojskowy Instytut Medyczny

    RECRUITING

    Legionowo, Poland

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