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Study on the Effectiveness and Safety of Datopotamab Deruxtecan Compared to Chemotherapy in Adults with Advanced Triple-negative Breast Cancer

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 clinical trial is focused on studying the effectiveness and safety of a new treatment called Datopotamab deruxtecan (also known as Dato-DXd) for patients with a specific type of breast cancer known as triple-negative breast cancer (TNBC). This type of breast cancer is characterized by the absence of three common receptors known to fuel most breast cancer growths. The study is designed for patients whose cancer has either returned and cannot be surgically removed or has spread to other parts of the body, and who are not suitable for a type of treatment called PD-1/PD-L1 inhibitor therapy.

The trial will compare the new treatment, Datopotamab deruxtecan, with standard chemotherapy options, which include medications such as carboplatin, paclitaxel, capecitabine, and eribulin mesylate. These medications are commonly used in chemotherapy to treat various types of cancer by stopping the growth of cancer cells. The purpose of the study is to determine if the new treatment is more effective in prolonging the time patients live without their disease getting worse and in improving overall survival compared to the standard chemotherapy options.

Participants in the study will be randomly assigned to receive either the new treatment or one of the standard chemotherapy options. The treatment will be administered through an infusion, which is a method of delivering medication directly into the bloodstream. The study will monitor the participants' health and response to the treatment over time to gather information on the effectiveness and safety of Datopotamab deruxtecan compared to the standard treatments. The trial aims to provide valuable insights into better treatment options for patients with triple-negative breast cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    Blood tests and imaging studies such as CT or MRI scans are performed to establish a baseline for the study.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either datopotamab deruxtecan or a chemotherapy regimen chosen by the investigator.

    The chemotherapy options include carboplatin, paclitaxel, capecitabine, eribulin mesylate, or paclitaxel albumin-bound.

  3. Step 3

    Treatment administration

    For those receiving datopotamab deruxtecan, the medication is administered via intravenous infusion.

    Participants receiving chemotherapy will follow the specific administration route for each drug: carboplatin, paclitaxel, eribulin mesylate, and paclitaxel albumin-bound are given intravenously, while capecitabine is taken orally.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment and any side effects. This includes physical exams, blood tests, and imaging studies.

    Participants are evaluated for progression-free survival and overall survival, which are key measures of the study's success.

  5. Step 5

    End of treatment

    The treatment continues until disease progression, unacceptable side effects, or the participant decides to withdraw from the study.

    After the treatment phase, follow-up assessments are conducted to monitor long-term outcomes and any delayed side effects.

Who can join the trial?

18 criteria

  • Participant must be at least 18 years old at the time of screening.
  • Participants with a history of treated spinal cord compression or stable brain metastases can join if they don't need treatment with steroids or anticonvulsants, are no longer showing symptoms, and have recovered from radiation therapy effects. At least 2 weeks should have passed since the end of radiation therapy, and at least 3 days since stopping steroid treatment for brain-related issues.
  • Participant must have proper organ and bone marrow function within 7 days before joining the study.
  • Participant should have a minimum life expectancy of 12 weeks.
  • Both males and females can participate.
  • Women who can have children must have a negative pregnancy test before joining.
  • Female participants must be at least 1 year post-menopausal, surgically sterile, or using a highly effective birth control method. They must continue using birth control for at least 7 months after the last dose and should not donate or retrieve eggs or breastfeed during this time.
  • Male participants who are sexually active with a woman who can have children must be surgically sterile or use an acceptable birth control method during the study and for at least 6 months after the last dose. They should not donate sperm during this time.
  • Participant must be able to give signed informed consent and follow the study requirements.
  • Participant must provide signed consent for optional genetic research before giving a sample for genetic studies.
  • Participant must have a confirmed diagnosis of locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) that cannot be treated with the intent to cure.
  • Participant must not have had prior chemotherapy or other systemic anti-cancer therapy for metastatic or locally recurrent inoperable breast cancer.
  • Participant must not be a candidate for PD-1/PD-L1 inhibitor therapy.
  • Participant must have at least one measurable tumor that has not been treated with radiation, which can be accurately measured using CT or MRI scans.
  • Participant must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1, indicating they are fully active or have some restrictions but can still perform light work.
  • Participant must be eligible for one of the chemotherapy options listed in the study, based on their disease-free interval and previous taxane exposure.
  • Participant must have had an adequate period without treatment before starting the study.
  • Participant must provide a tumor sample before joining the study. If a recent sample is not available, an older sample may be used with approval.

Who cannot join the trial?

6 criteria

  • Patients who have a type of breast cancer called Triple-negative Breast Cancer (TNBC) that has come back in the same area and cannot be removed by surgery, or has spread to other parts of the body.
  • Patients who are candidates for a type of treatment called PD-1/PD-L1 inhibitor therapy. This is a treatment that helps the immune system fight cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial groups.
  • Patients who are not female or male, as the study includes both genders.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Datopotamab Deruxtecan (Dato-DXd) is an experimental medication being studied for its effectiveness in treating patients with a specific type of breast cancer known as triple-negative breast cancer. This medication is designed to target and deliver chemotherapy directly to cancer cells, potentially reducing the growth and spread of the cancer. It is being compared to other chemotherapy options to see if it can provide better outcomes for patients who cannot use certain other cancer treatments.

What is already known about the treatment

Datopotamab Deruxtecan – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating locally recurrent inoperable or metastatic triple-negative breast cancer. It is not yet widely used in standard medical practice but shows promise in ongoing research. The main therapeutic indication is for patients who are not candidates for PD-1/PD-L1 inhibitor therapy. At the molecular level, Datopotamab Deruxtecan works by delivering a potent chemotherapy agent directly to cancer cells, using an antibody-drug conjugate mechanism. It is classified pharmacologically as an antibody-drug conjugate, specifically targeting cancer cells to minimize damage to healthy cells.

Investigated diseases

Triple-negative Breast Cancer – This is a type of breast cancer that lacks three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER-2/neu gene. It is considered more aggressive and harder to treat than other types of breast cancer. The disease can be locally recurrent, meaning it returns in the same area after treatment, or metastatic, meaning it has spread to other parts of the body. It progresses by growing and spreading rapidly, often leading to symptoms such as lumps in the breast or underarm, changes in breast shape, and skin dimpling. Since it does not respond to hormonal therapy or medicines that target HER-2, treatment options are limited. The progression of the disease is typically monitored through imaging tests and physical examinations.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509260-25-00Protocol codeD926PC00001Estimated enrolment600 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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