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Study Comparing Trastuzumab Deruxtecan with Chemotherapy for Patients with HER2-Low, Hormone Receptor Positive Breast Cancer After Endocrine Therapy Progression

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 a type of breast cancer known as HER2-low, hormone receptor positive breast cancer. This type of cancer has progressed despite treatment with hormone therapy in patients with advanced or metastatic disease. The study will compare the effects of a new treatment called Trastuzumab Deruxtecan (also known as DS-8201a or T-DXd) with other chemotherapy options chosen by the doctors involved in the study.

The purpose of the study is to evaluate how well Trastuzumab Deruxtecan works compared to the other chemotherapy treatments. Participants will receive either Trastuzumab Deruxtecan or a chemotherapy treatment selected by their doctor. The chemotherapy options may include medications such as Paclitaxel, Abraxane (a form of paclitaxel), or Capecitabine. These treatments are given through an infusion, which means they are administered directly into the bloodstream through a vein, or taken orally in the case of Capecitabine.

The study will monitor participants over a period of time to observe the effects of the treatments on their cancer. The main focus will be on how long the cancer stays under control and the overall survival of the participants. The study will also look at the safety and side effects of Trastuzumab Deruxtecan compared to the other chemotherapy treatments. Participants will be closely monitored by their healthcare team throughout the study to ensure their safety and well-being.

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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age and medical history related to breast cancer.

    The study focuses on patients with HER2-low, hormone receptor-positive breast cancer that has progressed after endocrine therapy.

  2. Step 2

    Treatment assignment

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

    The choice of chemotherapy may include medications such as paclitaxel, paclitaxel albumin-bound, or capecitabine.

  3. Step 3

    Medication administration

    Trastuzumab deruxtecan is administered through an intravenous infusion. The frequency and dosage are determined by the study protocol.

    If assigned to chemotherapy, paclitaxel or paclitaxel albumin-bound is given intravenously, while capecitabine is taken orally.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the effectiveness of the treatment and to check for any side effects.

    Assessments include imaging tests and laboratory evaluations to track disease progression and response to treatment.

  5. Step 5

    Study duration

    The study is expected to continue until June 2026, with individual participation lasting as long as the treatment is effective and tolerated.

    Participants are followed up regularly to evaluate overall survival and progression-free survival.

Who can join the trial?

9 criteria

  • Patients must be at least 18 years old.
  • Must have breast cancer that is advanced or has spread to other parts of the body (metastatic).
  • The cancer must have a history of being **HER2-low** or negative. **HER2** is a protein that can affect the growth of cancer cells. **HER2-low** means the cancer has low levels of this protein.
  • The cancer must have **hormone receptor positive (HR+)** disease, meaning the cancer grows in response to hormones.
  • Must have enough tumor samples to check the **HER2** status.
  • The disease must have gotten worse after at least two previous treatments with hormone therapy, with or without other targeted treatments. If the disease got worse within 24 months of hormone therapy after surgery, it counts as one treatment.
  • The disease must have gotten worse on hormone therapy plus a **CDK4/6 inhibitor** within 6 months of starting the first treatment for metastatic disease. A **CDK4/6 inhibitor** is a type of drug that helps stop cancer cells from growing.
  • Must not have had chemotherapy for advanced or metastatic breast cancer before.
  • Must have adequate organ and bone marrow function as defined by the study protocol. This means the organs and bone marrow are working well enough to participate in the study.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have not shown progression of their cancer after receiving hormone therapy.
  • Patients who have a different level of HER2 protein than the one specified in the study.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or attend required visits.
  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study medication or its ingredients.
  • Patients who are unable to provide informed consent, which means they cannot understand and agree to the study details.
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Investigated drugs

  • Trastuzumab Deruxtecan (T-DXd)

    is a medication used in this clinical trial to treat breast cancer. It is specifically designed for patients with HER2-low, hormone receptor-positive breast cancer that has progressed despite previous endocrine therapy. This medication works by targeting and delivering chemotherapy directly to cancer cells, which may help to slow down or stop the growth of the cancer.

  • Investigator's Choice Chemotherapy

    refers to a selection of standard chemotherapy treatments chosen by the doctors involved in the trial. These treatments are used as a comparison to evaluate the effectiveness of Trastuzumab Deruxtecan. The specific chemotherapy drugs used can vary, but they are commonly used options for treating breast cancer that has not responded to other treatments.

What is already known about the treatment

Trastuzumab Deruxtecan – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating HER2-low, hormone receptor-positive breast cancer that has progressed despite endocrine therapy in a metastatic setting. It is an antibody-drug conjugate, combining a targeted therapy with chemotherapy, designed to deliver the drug directly to cancer cells. The main therapeutic indication is for certain types of breast cancer, and it works by binding to the HER2 protein on cancer cells, allowing the attached chemotherapy to enter and kill the cells. Trastuzumab Deruxtecan is classified as an antineoplastic agent.

Investigated diseases

HER2-Low, Hormone Receptor Positive Breast Cancer – This type of breast cancer is characterized by low levels of the HER2 protein and the presence of hormone receptors. It typically occurs when cancer cells have a HER2 protein expression that is lower than what is considered HER2-positive but higher than HER2-negative. The cancer progresses as it grows and spreads to other parts of the body, often after initial treatment with hormone therapy. This progression can lead to the cancer becoming more aggressive and resistant to standard treatments. The disease is often monitored for changes in tumor size and spread to assess its progression. Understanding the specific characteristics of this cancer type is crucial for determining the most effective treatment approach.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516653-44-00Protocol codeD9670C00001Estimated enrolment523 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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