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Study of Datopotamab Deruxtecan for Patients with Triple-Negative Breast Cancer and New or Worsening Brain Metastases

Verified siteInvestigationalNo placebo
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What is this trial about?

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

This clinical trial is focused on studying triple-negative breast cancer, a type of breast cancer that does not have any of the three common receptors known to fuel most breast cancer growth. The study is specifically looking at patients who have newly diagnosed or progressing brain metastases, which means the cancer has spread to the brain. The treatment being tested is called Datopotamab deruxtecan, also known by its code name Dato-DXd or DS-1026a. This medication is given as a solution through an infusion into the veins.

The purpose of the study is to evaluate how well Dato-DXd can induce responses in the central nervous system (CNS) of patients with this type of breast cancer and brain metastases. During the study, participants will receive the medication and be monitored for their response to the treatment. Some participants may receive a placebo, which is a substance with no active medication. The study will observe how the cancer responds in the brain and other parts of the body, as well as track the overall survival and progression-free survival of the participants.

The study will take place over a period of time, with regular assessments to check the effectiveness of the treatment. The goal is to gather information on how well Dato-DXd works in treating brain metastases in patients with triple-negative breast cancer, providing valuable insights into potential new treatment options for this challenging condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be informed about the purpose and procedures involved. You will be required to provide written consent, confirming your understanding and willingness to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes verifying your medical history, current health status, and specific criteria such as having triple-negative breast cancer with newly diagnosed or progressing brain metastases.

  3. Step 3

    Treatment administration

    You will receive the medication datopotamab deruxtecan as a solution for infusion. This means the medication will be administered directly into your bloodstream through a vein. The frequency and dosage will be determined by the study protocol and your healthcare provider.

  4. Step 4

    Regular monitoring

    Throughout the study, regular monitoring will be conducted to assess your response to the treatment. This includes both intracranial (inside the skull) and extracranial (outside the skull) evaluations to measure the effectiveness of the treatment.

  5. Step 5

    Follow-up visits

    You will be required to attend follow-up visits as scheduled by the study team. These visits are essential for monitoring your health and the progression of the disease, as well as for collecting data on the treatment's impact.

  6. Step 6

    Completion of the study

    Upon completion of the study, a final assessment will be conducted. This will include a comprehensive evaluation of your health status and the overall outcomes of the treatment.

Who can join the trial?

19 criteria

  • Must have a confirmed diagnosis of breast cancer.
  • The breast cancer must be triple-negative, which means it does not have three common types of receptors known to fuel most breast cancer growth.
  • Must have newly diagnosed brain metastases (cancer that has spread to the brain) that have not been treated, or brain metastases that are getting worse after previous treatment.
  • Must have measurable disease according to specific criteria used by doctors to assess brain tumors.
  • There should be no need for immediate local treatment of the brain metastases.
  • Having type II leptomeningeal disease (cancer spread to the membranes surrounding the brain and spinal cord) is allowed if it is suspected based on symptoms and imaging tests.
  • Must have a Karnofsky Performance Status (KPS) of 70% or higher, which means the patient is able to care for themselves with some assistance, and an Eastern Cooperative Oncology Group (ECOG) score of 2 or less, indicating they are up and about more than half the day.
  • Must need systemic anti-cancer treatment, which is treatment that affects the entire body.
  • Previous treatment with PD-1 or PD-L1 inhibitors (types of immunotherapy) and TROP-2 targeted agents (a type of targeted therapy) is allowed.
  • Must have a life expectancy of at least 3 months.
  • Must be 18 years of age or older.
  • Must be able to tolerate the therapy being studied.
  • Must have adequate function of the bone marrow, liver, and kidneys.
  • Must have enough time since the last treatment before joining the study, including:
    • At least 3 weeks since major surgery.
    • At least 4 weeks since radiation therapy to the chest.
    • At least 2 weeks since palliative radiation therapy to other areas.
    • At least 3 weeks since chemotherapy or small-molecule targeted agents.
    • At least 4 weeks since antibody-based treatment (ongoing treatment with denosumab is allowed).
    • Must be able to understand the purpose of the study and provide written informed consent.

Who cannot join the trial?

5 criteria

  • Patients who do not have triple negative breast cancer cannot participate.
  • Patients without newly diagnosed or progressive brain metastases cannot participate. Brain metastases are cancer cells that have spread to the brain from another part of the body.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Both female and male patients can participate, but those who do not meet other criteria cannot.
  • Patients who are considered part of a vulnerable population may not be eligible. Vulnerable populations include groups who may have limited ability to give informed consent or are at higher risk in clinical trials.
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Investigated drugs

Dato-DXd is a medication being studied for its potential to help treat patients with a specific type of breast cancer known as triple-negative breast cancer (TNBC). This type of cancer can sometimes spread to the brain, and Dato-DXd is being tested to see if it can help reduce or control these brain metastases. The medication works by targeting cancer cells and delivering a powerful drug directly to them, which may help to shrink the tumors or stop them from growing. This study aims to see how well Dato-DXd can work in patients who have just been diagnosed with brain metastases or whose brain metastases are getting worse.

What is already known about the treatment

daTopotamab-derUXtecan (Dato-DXd; DS-1026a) – This medication is administered intravenously, meaning it is given through a vein. It is currently being studied in clinical trials, specifically for its effects on patients with triple-negative breast cancer that has spread to the brain. The main purpose of this medication is to help reduce or control the growth of cancer in the brain. At the molecular level, it works by delivering a toxic drug directly to cancer cells, which helps to kill them while minimizing damage to healthy cells. It is classified as an antibody-drug conjugate, which is a type of targeted cancer therapy.

Investigated diseases

Triple Negative Breast Cancer – Triple Negative Breast Cancer is a type of breast cancer that lacks three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER2 protein. This absence makes it distinct from other breast cancer types, as it does not respond to hormonal therapy or therapies that target HER2 receptors. The disease often progresses more aggressively than other forms of breast cancer. It can spread to other parts of the body, including the brain, leading to complications such as brain metastases. The progression of the disease is typically monitored through imaging and clinical evaluations to assess the spread and growth of cancerous cells.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518819-19-00Protocol codeTuxedo-2Estimated enrolment26 patientsSponsorMedical University Of Vienna

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