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Study of Trastuzumab Deruxtecan and Pertuzumab for Patients with HER2-Positive Metastatic Breast Cancer Who Have Not Received Prior Treatment

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves patients with HER2-positive breast cancer that has spread to other parts of the body or has advanced locally. HER2-positive means that cancer cells have too much of a certain protein called HER2 on their surface, which makes the cancer grow faster. The study is testing two medications given together: trastuzumab deruxtecan, also known as T-DXd or DS-8201, and pertuzumab. Both medications are given through a vein as an infusion. The study also uses two digital health tools called CANKADO PRO-React Onco and RESILIENCE MD, which are smartphone applications that help monitor symptoms and side effects. These digital tools allow patients to report how they are feeling and provide educational information about managing side effects related to the treatment.

The purpose of this study is to see how well the combination of trastuzumab deruxtecan and pertuzumab works as a first treatment for this type of breast cancer when using digital tools to actively manage side effects, and to understand how this treatment affects quality of life. During the study, patients will receive the study medications every three weeks through infusion. They will use a smartphone application to regularly track their symptoms, medication intake, and overall well-being. The digital platform can send alerts to doctors if symptoms become severe or worsen, allowing the medical team to adjust care quickly. Some patients may also have access to optional support programs through the app, such as help with fatigue, physical activity guidance, and meditation, depending on their country. Patients will need to have a smartphone with internet access that meets specific technical requirements to use these digital tools.

The study will measure several things, including how long it takes before patients need to start a different cancer treatment, and how long it takes for physical functioning to worsen based on quality of life questionnaires. Doctors will also track side effects, how often doses need to be adjusted, how well patients can continue treatment, and how often patients need emergency visits or hospitalizations. The study will look at how the cancer responds to treatment, including whether tumors shrink or disappear, and how long any response lasts. Quality of life will be measured using questionnaires that ask about physical symptoms, daily functioning, and overall health status. The study will also track how well patients use the digital health tools and how satisfied they are with the monitoring system and the care they receive.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The treatment will begin on Cycle 1 Day 1. Each cycle lasts a specific duration, and the treatment will continue according to the schedule determined by the study protocol.

    Two medications will be administered: trastuzumab deruxtecan (also called T-DXd) and pertuzumab. Both medications will be given through a vein, which is called intravenous infusion.

    The specific dosage, frequency, and duration of each medication will be determined according to the study protocol and individual medical assessment.

  2. Step 2

    Regular monitoring and assessments

    Throughout the treatment, heart function will be monitored regularly. Before starting treatment, a test called LVEF (which measures how well the heart pumps blood) must show a result of at least 50%.

    Physical examinations and blood tests will be performed at scheduled intervals to check blood cell counts, liver function, and kidney function.

    Imaging scans will be conducted periodically to evaluate how the disease is responding to treatment. These assessments will follow RECIST version 1.1 criteria, which is a standardized method for measuring tumor response.

  3. Step 3

    Use of digital health tools

    A smartphone with internet connection will be required throughout the study. The device must have Android 8.0 or newer, or iOS 15.0 or newer for one application, and Android 13.0 or newer, or iOS 17.0 or newer for another application.

    Regular assessments will need to be completed using digital applications at specified times. These include surveys about symptoms and quality of life.

    Oxygen level measurements using an oximeter (a device that clips onto a finger to measure oxygen in the blood) may be required at certain timepoints.

    Educational content and self-management modules may be available through these digital tools.

  4. Step 4

    Reporting of symptoms and side effects

    Symptoms and side effects will be monitored throughout treatment using questionnaires called PRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events).

    Quality of life will be assessed using standardized questionnaires: EORTC QLQ-C30 (a general cancer quality of life questionnaire) and EORTC QLQ-BR42 (a breast cancer-specific questionnaire).

    These questionnaires will measure various aspects including physical functioning, role functioning, pain, nausea, vomiting, and overall health status.

    If certain symptoms or alerts are triggered through the digital monitoring system, additional medical visits or interventions may be scheduled.

  5. Step 5

    Management of side effects

    Medications to prevent or manage nausea and vomiting may be prescribed. A combination regimen of 3 anti-nausea medications may be used as a preventive measure.

    If side effects occur, the dose of study medication may be reduced or temporarily stopped to allow recovery.

    Additional supportive care medications may be prescribed as needed to manage any side effects that develop.

    In some cases, if side effects are significant, hospitalization may be necessary.

    If brain involvement is present and symptoms occur, corticosteroid medication (such as dexamethasone) may be used, but the dose should not exceed 3 mg per day or equivalent.

  6. Step 6

    Treatment continuation and adjustments

    Treatment will continue as long as the disease does not progress and side effects remain manageable.

    The actual amount of medication received and the duration of treatment will be recorded throughout the study.

    If treatment needs to be interrupted due to side effects, it may be resumed once recovery occurs.

    If the disease progresses or unacceptable side effects develop, treatment may be discontinued and alternative therapy may be considered.

  7. Step 7

    Follow-up period

    After treatment ends, follow-up will continue to monitor disease status and overall health.

    Information about any subsequent cancer treatments that are started after study treatment ends will be recorded.

    Survival status and overall well-being will be tracked as part of the study follow-up.

    The estimated duration of participation in the study, including follow-up, extends until May 2030.

Who can join the trial?

18 criteria

  • You must be at least 18 years old when signing the consent form
  • You must have HER2-positive breast cancer (a type of breast cancer where cancer cells have too much of a specific protein called HER2) that has spread to other parts of your body or is advanced in your local area
  • Your cancer must be confirmed as HER2-positive through laboratory testing, meaning the test shows either very strong staining (called IHC 3+) or a positive genetic test (called ISH+)
  • Your cancer must also be tested to determine if it has hormone receptors (proteins called ER and/or PR that respond to hormones), which can be either positive or negative
  • You must not have received chemotherapy (strong cancer-killing medicines) or HER2-targeted treatments for your advanced or spread cancer before. However, you may have received up to one type of hormone therapy for spread cancer, and you may have received chemotherapy or HER2-targeted treatments after surgery or before surgery in the past
  • If you previously received a specific type of cancer drug containing an exatecan derivative in the period after surgery, at least 12 months must have passed since your last dose without cancer returning
  • Your cancer must be measurable according to standard guidelines called RECIST v1.1, which means doctors can track changes in tumor size
  • Your heart's pumping ability, measured by LVEF (left ventricular ejection fraction), must be at least 50 percent within 28 days before starting treatment
  • Your expected survival time must be at least 12 weeks
  • Your general health and ability to perform daily activities, measured by ECOG performance status, must be rated 0, 1, or 2 on a scale where lower numbers mean better functioning
  • You must have adequate blood cell counts and proper functioning of your organs, confirmed by laboratory tests
  • You must have a tissue sample available from your spread cancer for laboratory analysis. This can be from a new biopsy or a recent stored sample
  • If you have cancer that has spread to your brain, you may be eligible if: the brain tumors are not larger than 2.0 cm (larger ones require special approval), you do not need more than 3 mg per day of a steroid medicine called dexamethasone, and if you take seizure medicines, your dose must be stable for at least 14 days. If you had brain radiation or surgery, at least 21 days must have passed
  • You must be able to understand the study and voluntarily sign the consent form before any study procedures begin
  • You must have access to a smartphone with internet connection that meets specific technical requirements: for Resilience PRO app, Android 8.0 or newer, or iOS 15.0 or newer; for Cankado PRO-React app, Android 13.0 or newer, or iOS 17.0 or newer
  • If you are a man or a woman who can become pregnant and you engage in sexual activity that could result in pregnancy, you must agree to use highly effective birth control methods as specified by the study
  • Enough time must have passed since your last cancer treatment before starting this study treatment, according to specific washout periods
  • If you are in France, you must be affiliated with the social security system

Who cannot join the trial?

3 criteria

  • You have received previous chemotherapy (strong cancer-fighting medicines) or HER2-targeted therapy (specific treatment aimed at a protein called HER2 on cancer cells) for advanced or metastatic disease (cancer that has spread to other parts of the body or has grown significantly)
  • Your breast cancer is not HER2-positive (this means your cancer cells do not have high levels of a protein called HER2 that helps cancer cells grow)
  • Your breast cancer is not locally advanced (cancer that has grown into nearby tissues) or metastatic (cancer that has spread to distant parts of the body)
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Investigated drugs

  • Trastuzumab Deruxtecan

    is a targeted cancer medication used to treat breast cancer that is HER2-positive, which means the cancer cells have too much of a protein called HER2 on their surface. This medication works by attaching to the HER2 protein and delivering a cancer-killing drug directly to the cancer cells. It is given through an infusion into a vein.

  • Pertuzumab

    is another targeted cancer medication that also works against HER2-positive breast cancer. It attaches to a different part of the HER2 protein than trastuzumab deruxtecan and helps prevent cancer cells from growing and dividing. This medication is also given through an infusion into a vein and is used in combination with other treatments to help fight the cancer more effectively.

What is already known about the treatment

  • Trastuzumab Deruxtecan

    Trastuzumab Deruxtecan, also known as T-DXd, is an injectable medication given directly into the vein that combines a targeted antibody with a chemotherapy drug to treat HER2-positive breast cancer that has spread to other parts of the body. This medicine is currently approved and used in clinical practice, and ongoing studies are exploring its use as a first-line treatment combined with another drug called pertuzumab. It works by attaching to HER2 proteins on cancer cells and delivering the chemotherapy directly inside them, which helps destroy the cancer cells while limiting damage to healthy tissue. T-DXd belongs to a class of medications called antibody-drug conjugates, which are designed to target cancer cells more precisely than traditional chemotherapy.

  • Pertuzumab

    Pertuzumab is an injectable medication administered through a vein that is used to treat HER2-positive breast cancer, often in combination with other cancer treatments. This medicine is well-established in medical practice and is approved for treating breast cancer that has spread beyond the breast or nearby lymph nodes. It works by blocking HER2 proteins on the surface of cancer cells from pairing up with other proteins, which prevents the cancer cells from receiving growth signals and helps slow or stop their multiplication. Pertuzumab is classified as a monoclonal antibody and a targeted therapy, meaning it specifically targets cancer cells with certain characteristics rather than affecting all rapidly dividing cells like traditional chemotherapy.

Investigated diseases

HER2-positive Breast Cancer – This is a type of breast cancer where cancer cells have higher than normal levels of a protein called HER2 on their surface. This protein promotes the growth of cancer cells, making this form of breast cancer typically more aggressive than other types. The disease can occur in the breast tissue and may spread to nearby lymph nodes or other parts of the body. When the cancer is locally advanced, it means it has grown into nearby tissues or lymph nodes but has not spread to distant organs. Metastatic breast cancer refers to cancer that has spread beyond the breast and nearby lymph nodes to other parts of the body such as bones, lungs, liver, or brain. The progression of this disease varies among patients, but without treatment it tends to grow and spread more quickly than HER2-negative breast cancers.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521805-41-00Protocol codeSOLTI-2402Estimated enrolment300 patientsSponsorSolti Group

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