Recruiting

Testing sacituzumab govitecan and trastuzumab deruxtecan in alternating pattern for patients with HER2-low triple-negative breast cancer

Fast replyRegistered drug

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 study is looking at patients with triple-negative breast cancer that is HER2-low and has spread to other parts of the body or has grown locally in a way that cannot be removed by surgery. Triple-negative breast cancer is a type of breast cancer where the cancer cells do not have certain receptors that are commonly found in other breast cancers, specifically having very low levels of estrogen and progesterone receptors. HER2-low means that the cancer cells have a small amount of a protein called HER2 on their surface. The study will test two medications called sacituzumab govitecan and trastuzumab deruxtecan, which are given through a vein. These medications will be given in an alternating pattern, meaning patients will switch between the two treatments rather than receiving just one continuously.

The purpose of the study is to see if using both medications in this alternating way helps patients live longer compared to using sacituzumab govitecan alone. The study will also look at how well the treatment works by measuring whether tumors shrink or stop growing, how long patients live without their cancer getting worse, and how the treatment affects their quality of life. Researchers will also carefully track any side effects or unwanted reactions that patients experience during the treatment to understand how safe and tolerable this approach is.

During the study, patients will be randomly assigned to receive either the alternating combination of both medications or sacituzumab govitecan alone. Both medications are given through an infusion into a vein, and the treatment continues for a period of weeks with regular monitoring visits. Throughout the study, doctors will perform regular check-ups, blood tests, and scans to see how the cancer is responding to treatment and to monitor the patient's overall health and heart function. Patients will also be asked to complete questionnaires about their quality of life and how they are feeling during treatment.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Start of treatment
The treatment begins with an alternating regimen of two different medications to treat her2-low triple-negative breast cancer.
The first medication is trastuzumab deruxtecan, which is administered through an intravenous line (a needle or tube into a vein) at a dose of 5.4 mg/kg (milligrams per kilogram of body weight).
Step 2
Alternating medication phase
After the initial period with the first medication, the treatment switches to sacituzumab govitecan.
This medication is also given through an intravenous line at a dose of 10 mg/kg (milligrams per kilogram of body weight).
Step 3
Ongoing monitoring
During the trial, the effectiveness of the medications is monitored by checking for a complete response (where all tumor lesions disappear), a partial response (where tumor size decreases by at least 30%), or stable disease (where the tumor does not grow significantly for at least 24 weeks).
The progression-free survival is tracked, which is the time from the start of the trial until the cancer grows or death occurs.
The safety and tolerability of the treatment are monitored by tracking adverse events (side effects) and determining if any doses need to be reduced or interrupted.
At week 24, a questionnaire is used to measure health status and quality of life.

Who can join the trial?

20 criteria

The patient must provide written informed consent, which is a signed document showing they understand and agree to participate in the study.
The patient must be covered by the French Social Security System or a similar healthcare insurance provider.
The patient must be willing and able to follow the study rules, including receiving treatments and attending all scheduled doctor visits and tests.
The patient must be at least 18 years old.
The patient must have triple-negative breast cancer that has either spread to other parts of the body (metastatic) or is growing locally and cannot be removed by surgery (locally advanced and unresectable).
The cancer must be classified as HER2-low, which is a specific type of breast cancer determined by a laboratory test called immunohistochemistry (IHC) or in situ hybridization (ISH).
The cancer must show very low levels of hormones, specifically having Estrogen Receptor and Progesterone Receptor levels of less than 10%.
The patient must be medically able to receive the specific medications sacituzumab-govitecan and T-Dxd.
The patient must have an ECOG performance status of 1 or less, which means they are physically active and able to carry out light work or daily activities with some limitations.
Women who may become pregnant and men participating in the study must agree to use effective contraception (birth control) during the study and for a set period after the treatment ends.
The patient must have healthy organ and bone marrow functions, meaning their blood and internal organs are working properly.
The hemoglobin level, which is a protein in red blood cells that carries oxygen, must be at least 9 g/dL.
The absolute neutrophil count (ANC), which measures a specific type of white blood cell that fights infection, must be at least 1500/mm3.
The platelet count, which helps the blood clot to stop bleeding, must be at least 100,000/mm3.
The total bilirubin level, a substance produced by the liver, must be within a safe range.
The levels of liver enzymes called alanine transaminase (ALT) and aspartate aminotransferase (AST) must be within safe limits.
The serum albumin level, a protein in the blood, must be at least 2.5 g/dL.
The creatinine clearance, which is a measure of how well the kidneys filter waste from the blood, must be at least 30 mL/min.
The patient must have healthy cardiac function, meaning the heart is pumping blood effectively, with a left ventricular ejection fraction (the percentage of blood leaving the heart each time it contracts) of 55% or higher.
Women who are able to have children must have a negative pregnancy test using blood or urine within 7 days before being assigned to a study group.

Who cannot join the trial?

12 criteria

You cannot participate if you have previously used an antibody-drug conjugate (ADC), which is a type of medicine that uses an antibody to deliver a drug directly to cancer cells, targeting HER2 or TROP2.
Women who are pregnant or breastfeeding at the start of the study, or those who plan to become pregnant during the study or up to 7 months after treatment, are not eligible.
People who are currently in custody (such as in prison) or under legal guardianship cannot join.
You cannot join if you are unwilling or unable to follow the required medical appointments due to your location, family, social situation, or mental health.
People with uncontrolled or significant cardiovascular disease, which refers to serious problems with the heart or blood vessels, are excluded.
Patients with brain metastases (cancer that has spread to the brain) are excluded, unless the cancer in the brain is asymptomatic (showing no symptoms), has been treated, is stable, and does not require ongoing corticosteroid treatment (medicines used to reduce inflammation).
Patients who have had or currently have interstitial lung disease (ILD) or pneumonitis (inflammation of the lung tissue) that required steroids (anti-inflammatory medicine) are not eligible.
Anyone with a medical history or condition that the investigator (the main doctor in charge of the study) believes is not safe or compatible with the study.
Patients with a known allergy or hypersensitivity (an extreme immune reaction) to any of the study drugs or their excipients (inactive substances used to deliver the medicine) cannot participate.
Any other medical or psychiatric (mental health) condition that the doctor believes might interfere with the study results or prevent you from completing the required exams.
People with any other illness that requires hospitalization (staying in the hospital) or is not compatible with the study treatment.
Patients who have started another medical study within the last 30 days are not eligible.

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
Centr Georges Francois Leclerc
Dijon, France
Verified
Centre Francois Baclesse
Caen, France
Responsive
Institut De Cancerologie De Lorraine
Vandoeuvre Les Nancy, France

Trial locations

Where you can join this trial

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

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

Trastuzumab deruxtecan
is a type of therapy that uses a targeted approach to fight cancer cells. It works by attaching to specific markers on the surface of certain cancer cells and then releasing a strong medicine directly into those cells to destroy them.
Sacituzumab govitecan
is a treatment designed to target specific proteins found on cancer cells. Once it attaches to these proteins, it delivers a potent medication into the cancer cell to help stop its growth and kill it.

What is already known about the treatment

Trastuzumab deruxtecan
This medication is administered through an intravenous injection into a vein and is currently used in medical practice to treat certain types of breast cancer. It belongs to a class of drugs called antibody-drug conjugates, which work by using a targeted protein to find cancer cells and then releasing a potent medicine directly into them to destroy them. This approach allows the treatment to focus on the tumor while attempting to minimize damage to healthy cells.
Sacituzumab govitecan
This drug is given through an intravenous infusion and is an established treatment for specific advanced breast cancers. Classified as an antibody-drug conjugate, it works by attaching a strong cell-killing agent to an antibody that seeks out specific markers on the surface of cancer cells. Once the antibody attaches to the target, the drug is released inside the cancer cell to stop it from growing and spreading.

Investigated diseases

HER2-low triple-negative breast cancer - This is a specific type of breast cancer characterized by the absence of estrogen and progesterone receptors and the absence of high levels of the HER2 protein. However, it is distinguished by having a very low amount of the HER2 protein on the surface of the cancer cells. The disease can begin in the breast and may spread to other parts of the body as it progresses. It is categorized as locally advanced or metastatic depending on how far the cells have moved from the original site.