A study comparing datopotamab deruxtecan with durvalumab versus datopotamab deruxtecan alone for patients with PDL1-negative metastatic triple-negative breast cancer

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What is this study about?

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.

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Franziskus Hospital Harderberg	Georgsmarienhütte	Germany
Hospital Beata Maria Ana	Madrid	Spain
Hospital Universitari Dexeus Grupo Quironsalud	Barcelona	Spain
Hospital Universitario Basurto	Bilbao	Spain
Praxisklinik Krebsheilkunde Fuer Frauen	Berlin	Germany
Hospital Universitario Ramon Y Cajal	Madrid	Spain
Hospital Arnau De Vilanova De Valencia	Valencia	Spain
Hospital Universitario Clínico San Cecilio	Granada	Spain
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Rotkreuzklinikum Muenchen gGmbH	Munich	Germany
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Überörtliche Berufsausübungsgemei nschaft	Troisdorf	Germany
Hqcipmej Ucxdfjyfnhlqy Rlffkfmq Df Murlhg	Malaga	Spain
Gyuveacpdqgefcoq Znjvlxs Bnph	Bonn	Germany
Kuopuusl Epwznqdimddbgzybviijhauw Hrpwhuviclgopjrqo	Essen	Germany
Hstxybqb Vhxw dpybcisi	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.09.2025
Spain	Recruiting	01.09.2025

Trial locations

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.

Investigated diseases:

Triple negative breast cancer

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.

Trial ID:

2024-519913-76-00

Protocol code:

1011098

NCT ID:

NCT06954480

Trial Phase:

Therapeutic exploratory (Phase II)

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A study comparing datopotamab deruxtecan with durvalumab versus datopotamab deruxtecan alone for patients with PDL1-negative metastatic triple-negative breast cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?