Study of patritumab deruxtecan versus drug combination in patients with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer

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What is this study about?

This study focuses on treating patients with hormone receptor-positive, HER2-negative breast cancer that has either spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable locally advanced). The main treatment being tested is patritumab deruxtecan (also known as MK-1022), which will be compared to other standard treatments chosen by doctors, including paclitaxel, capecitabine, doxorubicin, or other similar medications.

The purpose of this research is to determine how well patritumab deruxtecan works compared to standard treatments in controlling the disease and helping patients live longer. The study is designed for patients whose cancer has continued to grow despite previous treatment with hormone therapy and special medications called CDK4/6 inhibitors.

During the study, participants will be randomly assigned to receive either patritumab deruxtecan or one of the standard treatment options. All medications will be given through an intravenous infusion (directly into a vein), except for capecitabine which is taken as tablets by mouth. The treatment will continue as long as it is helping the patient and side effects are manageable.

1 Initial treatment assignment

You will be randomly assigned to receive either patritumab deruxtecan or another treatment chosen by your physician

Your physician will select from available treatments including paclitaxel, capecitabine, doxorubicin, or other approved medications

2 Treatment administration

If assigned to patritumab deruxtecan: You will receive the medication through intravenous infusion

If assigned to physician’s choice treatment: The medication will be given either through intravenous infusion or as oral medication, depending on the selected treatment

Your treatment will continue until your disease progresses or you experience unacceptable side effects

3 Regular monitoring

Your health status will be regularly evaluated using imaging scans to check if the cancer is responding to treatment

Your overall physical condition will be assessed using a standard performance scale

You will complete quality of life questionnaires about your physical functioning, emotional well-being, and pain levels

4 Safety monitoring

Your doctor will monitor you for any side effects throughout the treatment period

Regular health checks will include assessment of any new symptoms or health changes

5 Study duration

The study is planned to continue until July 2033

Your participation will last until your disease progresses or you need to stop treatment for other reasons

Who Can Join the Study?

  • Must have hormone receptor positive breast cancer that is either locally advanced (cannot be surgically removed) or has spread to other parts of the body (metastatic)
  • Must have confirmation from a central laboratory that the cancer is:
    HR-positive (responds to hormone therapy)
    HER2-negative (does not have high levels of HER2 protein)
    – Has evaluable HER3 (another protein) levels from a recent tissue sample
  • Must have had cancer progression or return while on previous treatment with:
    CDK4/6 inhibitor (a type of targeted therapy) combined with hormone therapy as first treatment for advanced breast cancer, or
    – Disease return during or within 24 months after completing treatment with CDK4/6 inhibitor given with hormone therapy after surgery
  • Must be suitable for at least one standard treatment option as determined by the doctor
  • Must have cancer that can be measured using special imaging criteria (RECIST 1.1)
  • If living with HIV, the infection must be well-controlled with anti-HIV medications
  • Must be able to perform daily activities independently or with minimal assistance (ECOG performance status of 0 or 1) within 7 days before joining the study
  • Must be an adult aged 18 years or older

Who Cannot Join the Study?

  • History of treatment with HER3-targeted therapy (a specific type of cancer treatment targeting HER3 proteins)
  • Active brain metastases (cancer that has spread to the brain) that are not treated and stable
  • Significant heart conditions including:
    • Heart failure (when heart cannot pump blood effectively)
    • Irregular heartbeat that is not controlled by medication
    • Heart attack within the past 6 months
  • Current treatment with other experimental drugs or participation in other clinical trials
  • Severe liver or kidney problems
  • Autoimmune conditions (diseases where the immune system attacks healthy cells) requiring systemic treatment
  • Active infections requiring treatment, including:
    • Hepatitis B
    • Hepatitis C
    • HIV
  • Known allergies to the study medications or their components
  • Pregnancy or breastfeeding
  • Unable to follow study procedures or attend scheduled visits

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Orszagos Onkologiai Intezet Budapest Hungary
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Klinikum Dortmund gGmbH Dortmund Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Klinikum Mutterhaus der Borromaeerinnen gGmbH Trier Germany
University General Hospital Of Heraklion Heraklion Greece
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie Olsztyn Poland
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku Bialystok Poland
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o. Slupsk Poland
Diakonie in Suedwestfalen gGmbH Siegen Germany
Centre Henri Becquerel Rouen France
Universitaetsklinikum Erlangen AöR Erlangen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Hospital Clinic De Barcelona Barcelona Spain
Universitaetsklinikum Magdeburg AöR Magdeburg Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Saarland University Hospital Homburg Germany
Klinikum Chemnitz gGmbH Chemnitz Germany
Semmelweis University Budapest Hungary
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
Hospital Universitario Virgen De Valme Sevilla Spain
Salve Medica Sp. z o.o. S.K. Lodz Poland
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Agaplesion Frankfurter Diakonie Kliniken gGmbH Frankfurt Germany
Krycfdti Ljpeg Gqrf Detmold Germany
Cqyegf Lkqu Bhsqtm Lyon France
Huuwwwkm Uoihxdkluqyqm Mkdfone Dy Vuaasgmysx Santander Spain
Blsozksvydw Vvlvnfzwo Ovczjjrzzuhj Kecskemet Hungary
Lkhzn Gxjvmld Huwlewal Oq Agpyqt Athens Greece
Avwsce Mphsbsi Cpoeek Sjbf Thessaloniki Greece
Nsfsmxqa Iwyxpdrm Oknapaneg Imz Mtwli Snjywjxkmnrdahupksloitiqfedi Iumptjml Bqqmljeh Cracow Poland
Acepoan Hvlxuxqe Athens Greece
Axxggbg Ojmofupirfr Pkma Gyayxlbx Xkfli Bergamo Italy
Ipntcwbi Cfjhlo Dpshqdgcusxgwtgnb L'hospitalet De Llobregat Spain
Mcm Mezwgyz Ciwidn Dgvpsgndhyh Gwvx Duesseldorf Germany
Hopdbjmu Unkddpwcvfyxl dj A Cnwsbz A Coruna Galicia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
02.10.2025
Germany Germany
Recruiting
02.10.2025
Greece Greece
Recruiting
02.10.2025
Hungary Hungary
Recruiting
02.10.2025
Italy Italy
Recruiting
02.10.2025
Poland Poland
Recruiting
02.10.2025
Spain Spain
Recruiting
02.10.2025

Trial locations

Patritumab deruxtecan (also known as HER3-DXd) is a targeted therapy medication that works by delivering cancer-fighting substances directly to cancer cells that have high levels of a protein called HER3. It’s designed to treat breast cancer cells while minimizing damage to healthy cells.

Treatment of Physician’s Choice (TPC) refers to a standard treatment option where the doctor selects from available approved therapies based on what they believe will work best for the individual patient. This could include various chemotherapy drugs or other approved treatments for breast cancer.

Hormone receptor positive breast cancer – A type of breast cancer where cancer cells grow in response to the hormones estrogen and/or progesterone. The cancer cells have special proteins called hormone receptors on their surface that attach to hormones in the bloodstream. When hormones bind to these receptors, they stimulate the cancer cells to grow and divide. This is one of the most common types of breast cancer, typically developing slowly over time. The cancer usually begins in the milk ducts or milk-producing glands of the breast tissue and can spread to other parts of the breast.

Trial ID:
2025-520582-51-00
Protocol code:
MK-1022-016
Trial Phase:
Therapeutic confirmatory (Phase III)

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