Recruiting

A study comparing datopotamab deruxtecan with durvalumab versus datopotamab deruxtecan alone for patients with PDL1-negative metastatic 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 study is looking at metastatic triple-negative breast cancer that is PDL1-negative. Triple-negative breast cancer is a type of breast cancer where the cancer cells do not have receptors for estrogen, progesterone, or a protein called HER2. Metastatic means the cancer has spread to other parts of the body beyond the breast. PDL1-negative refers to cancer cells that do not have a specific protein on their surface. The study will test two different treatment approaches. One group of patients will receive a combination of two medications called Datopotamab deruxtecan and Durvalumab, while another group will receive only Datopotamab deruxtecan. Both medications are given through a vein as an infusion. The purpose of the study is to see if the combination of the two medications works better than using just one medication alone in stopping the cancer from getting worse.

The study will compare how long patients go without their cancer getting worse when they receive the combination treatment versus the single medication. Patients will be randomly assigned to one of the two treatment groups, meaning they will not be able to choose which treatment they receive. During the study, patients will have regular check-ups and scans to see how well the treatment is working. The scans will be done using either computed tomography or magnetic resonance imaging, which are imaging techniques that create detailed pictures of the inside of the body. The study will also look at how long patients live overall, how many patients respond to the treatment, and how long any response to treatment lasts.

Additionally, the study will measure the overall benefit patients receive from the treatment and will track any side effects that occur. Quality of life will also be assessed using questionnaires to understand how the treatment affects patients' daily lives and overall well-being. Patients will need to provide tissue samples from their cancer so that tests can be done to confirm they are eligible for the study. Treatment can continue for up to 39 months depending on how well it works and how well it is tolerated.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Screening and baseline assessments
Before starting treatment, a series of tests will be performed to confirm eligibility for the trial. These assessments must be completed within 28 days prior to the start of treatment.
Blood tests will be conducted to check blood cell counts, liver function, kidney function, and other important markers. These include tests for white blood cells, platelets, red blood cells, liver enzymes, bilirubin, creatinine, and blood clotting factors.
Imaging scans will be performed using computed tomography (a detailed x-ray scan) or magnetic resonance imaging (a scan using magnets and radio waves) to measure the size and location of tumors. These scans must be done within 28 days before randomization.
Tumor tissue samples will be collected or existing samples will be reviewed to confirm the type of breast cancer and its characteristics, including testing for PD-L1 (a protein on tumor cells).
A pregnancy test will be performed for individuals of childbearing potential within 72 hours before the first dose of study treatment.
Physical examination and assessment of overall health status will be conducted using the ECOG performance status scale, which measures how the disease affects daily living abilities.
Step 2
Random assignment to treatment group
After completing all screening tests and confirming eligibility, assignment to one of two treatment groups will occur through a process called randomization.
One group will receive datopotamab deruxtecan combined with durvalumab.
The other group will receive datopotamab deruxtecan alone.
The assignment to either group is random and cannot be chosen.
Step 3
Treatment administration
Treatment will be given in cycles. Each cycle represents a specific period during which medications are administered.
On Day 1 of each cycle, the assigned medication(s) will be administered through an intravenous infusion (directly into a vein).
If assigned to the combination group, both datopotamab deruxtecan and durvalumab will be given as separate infusions on the same day.
If assigned to the single treatment group, only datopotamab deruxtecan will be given as an infusion.
The medications are provided as a solution for infusion, which means they are already prepared in liquid form for administration into the vein.
Treatment will continue for multiple cycles as long as the disease does not progress and the treatment is tolerated without unacceptable side effects.
Step 4
Regular monitoring and assessments during treatment
Throughout the treatment period, regular visits will be scheduled to monitor health status and treatment effects.
Blood tests will be performed regularly to check blood cell counts, liver function, kidney function, and other safety markers.
Physical examinations will be conducted to assess overall health and any changes in condition.
Imaging scans using computed tomography or magnetic resonance imaging will be performed at regular intervals to evaluate tumor size and determine if the treatment is working.
Any side effects or health changes will be recorded and assessed according to standard medical criteria.
Quality of life questionnaires will be completed at specified times to assess how the treatment affects daily life and well-being.
Step 5
Contraception requirements during treatment
If of childbearing potential, effective contraception must be used starting 14 days before the first dose of study treatment and continuing for 7 months after the last dose.
Acceptable contraception methods are those with a failure rate of less than 1% per year.
Egg donation or retrieval for personal use is not permitted during the study and for at least 7 months after the last treatment dose. Egg preservation should be considered before starting the trial.
Male participants with female partners of childbearing potential must use barrier contraception, such as a condom, during treatment and for up to 4 months after the last dose.
Male participants must not donate sperm from the start of treatment until at least 4 months after the last dose.
Step 6
Disease progression or treatment completion
Treatment will continue until the disease progresses, unacceptable side effects occur, or withdrawal from the study for other reasons.
Disease progression is determined by imaging scans that show tumor growth or spread according to specific measurement criteria called RECIST 1.1 (Response Evaluation Criteria in Solid Tumors).
If the disease progresses or treatment must be stopped, the final assessments will be conducted.
Step 7
Follow-up after treatment ends
After treatment ends, follow-up visits will continue to monitor long-term health outcomes.
Information about overall survival and disease status will be collected during this follow-up period.
The follow-up period will continue according to the study protocol requirements.

Who can join the trial?

14 criteria

You must be willing and able to provide written permission to join the study
You must be at least 18 years old, either female or male
You must have triple-negative breast cancer (a type of breast cancer where the cancer cells do not have certain proteins called ER, PR, and HER2) that has spread to other parts of the body or cannot be removed by surgery
Your cancer must be PD-L1 negative, which means a specific protein marker on your cancer cells is below a certain level (less than 10)
You must have at least one tumor that can be measured by a CT scan (a special type of x-ray) or MRI scan (a scan using magnets) that is at least 10 millimeters in size, or you must have certain types of bone damage caused by cancer
A sample of your tumor tissue must be available for testing, either from a previous surgery or biopsy, or your tumor must be accessible for a new biopsy (a procedure to remove a small piece of tissue)
Your general health condition must be good enough to perform daily activities with little or no symptoms (ECOG performance status of 0 or 1)
Your body weight must be more than 30 kilograms
Your blood tests must show adequate function: enough white blood cells, red blood cells, and platelets; proper kidney function; and proper liver function
If you are able to become pregnant, you must have a negative pregnancy test before starting treatment and agree to use effective birth control (methods that prevent pregnancy) starting 14 days before treatment and continuing for 7 months after the last dose
If you are able to become pregnant, you must not donate or use your own eggs during the study and for 7 months after treatment
If you are a male with a female partner who can become pregnant, you must use a barrier method of birth control such as a condom during treatment and for 4 months after the last dose
If you are male, you must not donate sperm during treatment and for 4 months after the last dose
You must be able to follow the study requirements and schedule

Who cannot join the trial?

6 criteria

Men cannot participate in this study because it is only for female patients
People younger than 18 years old cannot participate
Patients who do not have PDL1-negative metastatic triple-negative breast cancer cannot participate. This means the study is only for a specific type of breast cancer that has spread to other parts of the body, lacks three common receptors (estrogen, progesterone, and HER2), and tests negative for a protein called PDL1
Patients whose cancer has not spread to other parts of the body (those without metastatic disease) cannot participate
Patients with breast cancer that is not triple-negative cannot participate. Triple-negative means the cancer cells do not have receptors for estrogen, progesterone, or a protein called HER2
Patients whose tumors are PDL1-positive cannot participate. PDL1 is a protein found on some cancer cells that helps them hide from the immune system

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Verified sites

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

Gynaekologisches Zentrum Bonn
Verified
Bonn, Germany
Hospital Clinic De Barcelona
Verified
Barcelona, Spain
Hospital Universitario Virgen De La Victoria
Verified
Malaga, Spain

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Investigated drugs

Datopotamab deruxtecan
is a type of targeted cancer treatment that works by delivering chemotherapy directly to cancer cells. It is designed to attach to specific proteins on the surface of cancer cells and then release a cell-killing medicine inside those cells. This helps to destroy the cancer while potentially causing less harm to healthy cells.
Durvalumab
is an immunotherapy medication that helps your immune system fight cancer. It works by blocking a protein that prevents your immune system from attacking cancer cells. By blocking this protein, the medication allows your body's natural defenses to recognize and destroy cancer cells more effectively.

What is already known about the treatment

Datopotamab deruxtecan
This is an injectable cancer medication that is administered directly into a vein and is currently being studied in clinical trials for treating advanced breast cancer. It belongs to a class of drugs called antibody-drug conjugates, which work by attaching a cancer-killing chemical to an antibody that targets specific proteins on cancer cells, allowing the medication to deliver chemotherapy directly to the tumor while minimizing damage to healthy cells. In this particular study, it is being tested in patients with a specific type of breast cancer called triple-negative breast cancer that has spread to other parts of the body and does not express a protein called PD-L1 on its surface.
Durvalumab
This is an injectable immunotherapy medication given through an intravenous infusion that is approved for certain cancers and is being investigated in combination with other treatments for various types of cancer. It works by blocking a protein called PD-L1 that cancer cells use to hide from the body's immune system, essentially removing the cancer's protective shield and allowing the patient's own immune cells to recognize and attack the tumor more effectively. In this clinical trial, it is being tested together with datopotamab deruxtecan to see if the combination provides better results than using datopotamab deruxtecan alone in treating advanced triple-negative breast cancer.

Investigated diseases

Metastatic Triple-Negative Breast Cancer – This is a type of breast cancer that has spread beyond the breast to other parts of the body. Triple-negative means the cancer cells test negative for three types of receptors: estrogen receptors, progesterone receptors, and HER2 protein. This form of breast cancer tends to grow and spread more quickly than other types of breast cancer. The cancer cells can travel through the bloodstream or lymphatic system to form new tumors in distant organs such as the lungs, liver, bones, or brain. PD-L1-negative refers to cancer cells that do not express a specific protein called PD-L1 on their surface. The disease progresses as cancer cells continue to multiply and spread to additional areas of the body.