Clinique Saint-Pierre Ottignies (CSPO)
Ottignies, Belgium
Not recruiting
Study on the Safety and Effects of Trastuzumab Deruxtecan with Drug Combination for Patients with Metastatic HER2-low Breast Cancer
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 a type of breast cancer known as . This is a form of breast cancer that has spread to other parts of the body and shows low levels of a protein called HER2. The study will explore the effects of a treatment called (also known as T-DXd) when used in combination with other cancer-fighting medications. These medications include , , (also known as MEDI4736), , , and (also known as AZD-5363). The purpose of the study is to assess the safety and effectiveness of these combinations in treating HER2-low metastatic breast cancer.
The study is designed in two parts. In the first part, researchers will determine the best dose of T-DXd when combined with the other medications. In the second part, they will further evaluate the safety and tolerability of these combinations at the determined dose. Participants will receive the treatments through different methods, such as intravenous infusion (a method where the medication is given directly into a vein) or oral tablets. The study will monitor how the body responds to the treatment and any side effects that may occur.
Throughout the study, researchers will collect information on how well the treatment works in shrinking the cancer and how long it takes for the cancer to progress. They will also measure the levels of T-DXd and other substances in the blood to understand how the treatment is processed by the body. The study aims to provide valuable insights into new treatment options for patients with HER2-low metastatic 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.
Who can join the trial?
11 criteria
- Patients must be at least 18 years old.
- Both male and female patients can participate.
- Patients must have breast cancer that is confirmed by a medical test.
- The cancer must show a history of **HER2-low expression**. This means the cancer has low levels of a protein called HER2, which is checked using specific tests.
- The cancer must be either **HR+** or **HR-**. **HR+** means the cancer has hormone receptors, which are proteins that hormones can attach to. **HR-** means the cancer does not have these receptors.
- Patients must provide a sufficient sample of their tumor for testing.
- Patients must have an **ECOG Performance Status** of 0 or 1. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
- For patients with **HR+** disease:
- In Part 1: Patients must have had at least one previous treatment with hormone therapy, with or without additional targeted therapy, and at least one previous chemotherapy treatment for metastatic breast cancer.
- In Part 2: Patients can have had only one previous hormone therapy treatment, with or without additional targeted therapy, and no previous chemotherapy for metastatic breast cancer.
- For patients with **HR-** disease:
- In Part 1: Patients must have had at least one previous chemotherapy treatment for metastatic breast cancer.
- In Part 2: For Module 2, no previous treatments for metastatic breast cancer are allowed. For Modules 1 and 3, only one previous chemotherapy treatment for metastatic breast cancer is allowed.
Who cannot join the trial?
6 criteria
- Patients who do not have **metastatic breast cancer**. This means the cancer has spread to other parts of the body.
- Patients who do not have **HER2-low** breast cancer. HER2 is a protein that can affect the growth of cancer cells. HER2-low means the cancer cells have a small amount of this protein.
- Patients who have already received more than one prior treatment for advanced or metastatic disease. This means if you have had more than one treatment for cancer that has spread, you cannot participate.
- Patients who are not in the age range specified for the study. The study may have specific age requirements.
- Patients who are not part of the specified gender group. The study may be open to both males and females, or just one gender.
- Patients who are considered part of a **vulnerable population**. This means people who might need special protection or care, like children or those unable to make decisions for themselves.
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
Verified
Trial locations
Where you can join this trial
Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.
Not recruitingNot 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.
Investigated drugs
Trastuzumab Deruxtecan (T-DXd) is a medication being studied for its potential to treat metastatic HER2-low breast cancer. It is designed to target and deliver chemotherapy directly to cancer cells that have low levels of the HER2 protein, which is a common characteristic in certain types of breast cancer. The study aims to explore how well this medication works when used in combination with other anti-cancer agents, focusing on its safety, how the body processes it, and its ability to reduce tumor size.
What is already known about the treatment
Trastuzumab Deruxtecan (T-DXd) – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating metastatic breast cancer, specifically in patients with HER2-low expression. It is in the investigational stage, with ongoing research to determine its safety and optimal dosing when combined with other anti-cancer agents. The main therapeutic indication is for metastatic breast cancer with low HER2 expression. At the molecular level, Trastuzumab Deruxtecan works by targeting the HER2 protein on cancer cells, delivering a cytotoxic agent directly to the tumor, which helps to inhibit cancer cell growth. It is classified as an antibody-drug conjugate, combining targeted therapy with chemotherapy.
Investigated diseases
Metastatic Breast Cancer – This is a type of breast cancer that has spread beyond the breast to other parts of the body, such as the bones, liver, lungs, or brain. It is considered an advanced stage of breast cancer, often referred to as stage IV. The disease progresses as cancer cells travel through the bloodstream or lymphatic system to form new tumors in other organs. Symptoms can vary depending on where the cancer has spread, but may include bone pain, difficulty breathing, or neurological symptoms. The progression of metastatic breast cancer can be influenced by factors such as hormone receptor status and HER2 status. It is a chronic condition that requires ongoing management to control the spread and alleviate symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-505690-33-00Protocol codeD967JC00002Estimated enrolment192 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?