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Study Comparing Datopotamab Deruxtecan to Chemotherapy in Patients with Advanced Hormone Receptor-Positive, HER2-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 a type of breast cancer known as inoperable or metastatic hormone receptor-positive, HER2-negative breast cancer. This type of cancer cannot be removed by surgery and has spread to other parts of the body. The study is comparing a new treatment called Datopotamab deruxtecan (also known by its code name DS-1062a) with other chemotherapy options chosen by doctors. These chemotherapy options include Eribulin mesylate, Gemcitabine, Capecitabine, and Vinorelbine. The purpose of the study is to see if Datopotamab deruxtecan is more effective than the other chemotherapy treatments in improving the condition of patients with this type of breast cancer.

Participants in the study will receive either Datopotamab deruxtecan or one of the chemotherapy treatments chosen by their doctor. The study will monitor the participants over time to see how their cancer responds to the treatment. This includes looking at how long the cancer stays under control and the overall survival of the participants. The study will also assess the side effects of the treatments and how they affect the participants' quality of life.

The study is designed to provide important information about the effectiveness and safety of Datopotamab deruxtecan compared to standard chemotherapy options. This information could help doctors make better treatment decisions for patients with inoperable or metastatic hormone receptor-positive, HER2-negative breast cancer in the future. Participants will be closely monitored by healthcare professionals 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, type of breast cancer, and previous treatments.

    A negative pregnancy test is required for women of childbearing potential, and appropriate contraceptive measures must be in place.

  2. Step 2

    Randomization

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

    The chemotherapy options include eribulin mesylate, gemcitabine, capecitabine, and vinorelbine.

  3. Step 3

    Treatment administration

    If assigned to Datopotamab deruxtecan, it is administered through an intravenous infusion.

    If assigned to chemotherapy, the specific drug determines the method of administration: eribulin mesylate, gemcitabine, and vinorelbine are given via intravenous infusion, while capecitabine is taken orally.

  4. Step 4

    Treatment duration

    The treatment continues until disease progression, unacceptable side effects, or withdrawal from the study.

    Regular assessments are conducted to monitor the response to treatment and any side effects.

  5. Step 5

    Follow-up

    After treatment ends, follow-up visits are scheduled to monitor health status and any long-term effects.

    The study aims to assess progression-free survival and overall survival among participants.

Who can join the trial?

14 criteria

  • Participants must be at least 18 years old at the time of screening.
  • Participants must have **inoperable** or **metastatic** **hormone receptor-positive** (HR+), **HER2-negative** breast cancer. This means the cancer cannot be removed by surgery or has spread to other parts of the body, and it tests positive for certain hormone receptors but negative for a protein called HER2.
  • Participants must have tried and not be suitable for **endocrine therapy** (hormone therapy) and have been treated with 1 to 2 lines of chemotherapy for their inoperable or metastatic cancer. They must have shown progression on their most recent chemotherapy treatment.
  • Participants must be eligible for one of the chemotherapy options listed as ICC, which include eribulin, capecitabine, vinorelbine, or gemcitabine, as assessed by the investigator.
  • Participants must have an **ECOG Performance Status** of 0 or 1, which means they are fully active or have some symptoms but do not require bed rest.
  • Participants must have at least one measurable lesion that has not been previously treated with radiation, according to specific criteria (RECIST 1.1). Participants with only bone metastases are not allowed.
  • Participants with a history of treated spinal cord compression or inactive brain metastases can join if they do not need treatment with steroids or anticonvulsants and have recovered from radiation therapy effects. At least 2 weeks must have passed since the end of radiation therapy.
  • Participants must have adequate organ and bone marrow function, which includes specific levels of hemoglobin, neutrophils, platelets, bilirubin, liver enzymes (ALT and AST), and kidney function (creatinine clearance).
  • Participants must have a **Left Ventricular Ejection Fraction (LVEF)** of at least 50%, which is a measure of heart function, assessed by an echocardiogram or MUGA scan within 28 days of the first dose.
  • Participants must have had an adequate washout period from previous treatments before starting the study, which means a certain amount of time must have passed since their last major surgery, radiation therapy, or anticancer therapy.
  • Participants must have a **formalin-fixed paraffin-embedded (FFPE)** tumor sample available at the time of screening.
  • Participants must have a minimum life expectancy of 12 weeks at screening.
  • Participants must use contraception consistent with local regulations, and women must not use estrogens. Women of childbearing potential must have a negative pregnancy test and use effective birth control. Men must use condoms with spermicide and not donate sperm during the study.
  • Participants must be capable of giving signed informed consent, meaning they understand and agree to participate in the study.

Who cannot join the trial?

2 criteria

  • Patients who have not been diagnosed with **inoperable** or **metastatic** **hormone receptor-positive**, **HER2-negative breast cancer**. This means the cancer cannot be removed by surgery or has spread to other parts of the body, and it is a specific type of breast cancer that does not have a protein called HER2.
  • Patients who have not been treated with one or two prior lines of **systemic chemotherapy**. This refers to cancer treatment that uses drugs to reach cancer cells throughout the body.
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Investigated drugs

Dato-DXd is an investigational medication being studied for its potential to treat breast cancer that is hormone receptor-positive and HER2-negative. This type of breast cancer does not respond to hormonal therapies or HER2-targeted treatments. Dato-DXd is being tested to see if it can help patients whose cancer has spread or cannot be surgically removed, and who have already received one or two previous chemotherapy treatments. The goal is to determine if Dato-DXd can improve progression-free survival and overall survival compared to other chemotherapy options chosen by the study investigators.

What is already known about the treatment

Dato-DXd – Dato-DXd is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating inoperable or metastatic hormone receptor-positive, HER2-negative breast cancer. This medication is in the investigational stage and is not yet approved for general medical use. It is primarily indicated for patients who have already undergone one or two prior lines of systemic chemotherapy. Dato-DXd works by delivering a cytotoxic agent directly to cancer cells, targeting specific proteins on the cell surface, which helps to inhibit tumor growth. It is classified as an antibody-drug conjugate, a type of targeted cancer therapy.

Investigated diseases

Inoperable or Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer – This type of breast cancer is characterized by the presence of hormone receptors but lacks the HER2 protein, which influences the growth of cancer cells. It is termed "inoperable" when surgery is not a viable option due to the extent or location of the cancer. "Metastatic" indicates that the cancer has spread beyond the breast to other parts of the body. The progression of this disease involves the cancer cells continuing to grow and spread, often requiring systemic treatments like chemotherapy. Patients with this condition have typically undergone one or two prior lines of systemic chemotherapy. The disease's behavior can vary, with some cases progressing more slowly than others.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509631-37-00Protocol codeD9268C00001Estimated enrolment697 patientsSponsorAstraZeneca AB

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