Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study of Datopotamab Deruxtecan and Durvalumab for Adults with Untreated Triple-Negative or Hormone Receptor-Low/HER2-Negative Breast Cancer

Fast replyRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying treatments for breast cancer, specifically for patients with Triple-Negative Breast Cancer (TNBC) or hormone receptor-low/HER2-negative breast cancer. The study will evaluate the effectiveness of a new treatment combination involving Datopotamab Deruxtecan (Dato-DXd) and Durvalumab, both given before and after surgery. This will be compared to the current standard treatment, which includes Pembrolizumab and chemotherapy, also administered before and after surgery. The purpose of the study is to determine if the new treatment combination is more effective than the standard treatment.

Participants in the study will receive either the new treatment combination or the standard treatment. The new treatment involves the use of Dato-DXd, a medication designed to target and destroy cancer cells, and Durvalumab, which helps the immune system fight cancer. These medications will be given through an intravenous infusion, which means they are delivered directly into the bloodstream. The standard treatment includes Pembrolizumab, another medication that boosts the immune system, along with chemotherapy, which uses drugs to kill cancer cells. Some participants may also receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments.

The study will follow participants over a period of time to monitor their response to the treatments. This includes checking for the absence of cancer in the breast and lymph nodes after surgery, as well as tracking the time until any signs of cancer return or other health events occur. The goal is to see if the new treatment can improve outcomes for patients with these specific types of breast cancer. 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, the patient will be randomly assigned to one of two treatment groups. This assignment is done to compare the effectiveness of different treatment combinations for breast cancer.

  2. Step 2

    Neoadjuvant treatment phase

    In this phase, the patient will receive treatment before surgery. The treatment involves either datopotamab deruxtecan and durvalumab or pembrolizumab with chemotherapy.

    The medications are administered through intravenous infusion, which means they are given directly into the bloodstream through a vein.

  3. Step 3

    Surgery

    After completing the neoadjuvant treatment, the patient will undergo surgery to remove the breast cancer. The goal is to achieve a pathological complete response, meaning no cancer is found in the tissue removed during surgery.

  4. Step 4

    Adjuvant treatment phase

    Following surgery, the patient will receive additional treatment to help prevent cancer from returning. This phase includes durvalumab or pembrolizumab with or without chemotherapy, depending on the group assigned.

    The medications are again administered through intravenous infusion.

  5. Step 5

    Follow-up

    The patient will be monitored regularly to assess the effectiveness of the treatment and to check for any signs of cancer recurrence. This involves scheduled visits and tests as determined by the study protocol.

Who can join the trial?

6 criteria

  • Participants must be **18 years or older** at the time of signing the informed consent form.
  • Participants must have **Stage II or III** breast cancer that is either **triple-negative** or **hormone receptor-low/HER2-negative**. This means the cancer does not have certain proteins that are usually found in breast cancer.
  • Participants must have an **ECOG Performance Status** of **0 or 1**. This is a scale used to measure how well a person can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.
  • Participants must provide an **acceptable tumor sample** for testing.
  • Participants must have **adequate bone marrow reserve and organ function**. This means their blood and organs are working well enough to handle the treatment.
  • Participants must use **contraception** if they are male or female, following local rules about birth control for people in clinical studies.

Who cannot join the trial?

5 criteria

  • Patients who have already received treatment for their breast cancer cannot participate.
  • Patients with a type of breast cancer that is not Triple Negative or Hormone Receptor low/HER2-negative are excluded. Triple Negative means the cancer does not have any of the three common types of receptors known to fuel most breast cancer growth. Hormone Receptor low/HER2-negative means the cancer has low levels of hormone receptors and does not have the HER2 protein.
  • Patients who are not within the specified age range for the study cannot participate.
  • Both male and female patients are eligible, but those who do not meet other criteria will be excluded.
  • Patients who are considered part of a vulnerable population, which may include those unable to give informed consent, may be excluded.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Datopotamab Deruxtecan (Dato-DXd)

    is an experimental medication being studied for its potential to treat certain types of breast cancer. It is used in combination with other treatments to see if it can help shrink tumors before surgery and improve outcomes for patients with triple-negative or hormone receptor-low/HER2-negative breast cancer.

  • Durvalumab

    is a medication that helps the immune system recognize and attack cancer cells. In this trial, it is used both before and after surgery to see if it can improve the effectiveness of the treatment in patients with specific types of breast cancer.

  • Pembrolizumab

    is another medication that boosts the immune system's ability to fight cancer. It is used in this study in combination with chemotherapy to evaluate its effectiveness in treating breast cancer before and after surgery.

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 triple-negative or hormone receptor-low/HER2-negative breast cancer. It is an antibody-drug conjugate that targets cancer cells by binding to a specific protein on their surface, delivering a cytotoxic agent directly to the tumor. This targeted approach aims to minimize damage to healthy cells. Datopotamab Deruxtecan is classified as an antineoplastic agent.

  • Durvalumab

    Administered intravenously, Durvalumab is an immunotherapy drug currently under investigation for its role in treating triple-negative or hormone receptor-low/HER2-negative breast cancer. It works by blocking a protein that prevents the immune system from attacking cancer cells, thereby enhancing the body's natural defenses against the tumor. Durvalumab is classified as a monoclonal antibody.

  • Pembrolizumab

    This medication is given intravenously and is being evaluated in clinical trials for its potential to treat triple-negative or hormone receptor-low/HER2-negative breast cancer. Pembrolizumab functions by inhibiting a protein that restricts the immune system's ability to destroy cancer cells, thus boosting the immune response against the cancer. It is classified as a monoclonal antibody.

Investigated diseases

  • Triple Negative Breast Cancer

    This type of breast cancer is characterized by the absence of three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and HER2. It tends to be more aggressive and has fewer treatment options compared to other breast cancer types. The cancer cells in triple negative breast cancer do not have the receptors that are targeted by some of the most effective therapies, making it more challenging to treat. It often grows and spreads more quickly than other types of breast cancer. This type of cancer is more likely to affect younger women and those with a BRCA1 gene mutation.

  • Hormone Receptor-Low/HER2-Negative Breast Cancer

    This form of breast cancer has low levels of hormone receptors and lacks the HER2 protein, which is another common target for breast cancer treatments. The low presence of hormone receptors means that hormone therapy may not be as effective. It shares some characteristics with triple negative breast cancer but may have different growth patterns and responses to treatment. This type of cancer can be more difficult to treat due to the limited presence of targets for conventional therapies. It may require a combination of treatments to manage effectively.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505928-59-00Protocol codeD926QC00001Estimated enrolment1 900 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.