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Study of Trastuzumab Deruxtecan Versus Chemotherapy as Additional Treatment After Surgery for Patients with HER2-Positive Endometrial Cancer

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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 endometrial cancer that expresses a protein called HER2. Endometrial cancer is a type of cancer that starts in the lining of the uterus. The study will test a medication called DS-8201a, which is also known as trastuzumab deruxtecan. This medication will be compared to standard chemotherapy treatments that may include carboplatin, paclitaxel, cisplatin, or docetaxel. Some participants may also receive radiotherapy, which is a treatment using radiation to destroy cancer cells. The study will involve people who have had surgery to remove their cancer and currently have no signs of disease remaining.

The purpose of the study is to compare how well DS-8201a works compared to standard chemotherapy in preventing the cancer from coming back. The study will look at how long participants remain free of disease after treatment. Participants will be randomly assigned to receive either DS-8201a or one of the standard chemotherapy combinations. All medications will be given through a vein as an infusion. The treatment period can last up to 51 cycles for DS-8201a or between 4 to 18 cycles for the standard chemotherapy options, depending on which treatment is assigned. A cycle is a repeating period of time during which the medication is given.

During the study, participants will have regular check-ups that include imaging scans to look for any signs of cancer returning, blood tests to check organ function and blood cell counts, heart function tests using ultrasound or similar scans, and eye examinations. The study will also measure how participants feel and their quality of life using questionnaires. The doctors will monitor for any side effects or unwanted reactions to the medications throughout the study. The study will also collect blood samples to measure the levels of the study medication in the body and to check if the body develops any immune response to the treatment.

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
Initial treatment assignment
After joining the trial, you will be randomly assigned to receive either trastuzumab deruxtecan or standard chemotherapy treatment. This assignment is done by chance, similar to flipping a coin.
The treatment you receive will begin within 8 weeks after your endometrial cancer surgery.
Step 2
Pre-treatment assessments
Before starting treatment, your heart function will be checked to ensure your left ventricular ejection fraction (a measure of how well your heart pumps blood) is at least 50%. This test must be completed within 28 days before treatment begins.
Your physical condition will be assessed using a scale that measures your ability to perform daily activities. This assessment must be done no more than 14 days before treatment starts.
Blood tests will be performed within 14 days before treatment begins to check your organ function and bone marrow health. These tests may be repeated within 72 hours before your first treatment dose.
Step 3
Treatment phase - Option A: Trastuzumab deruxtecan
If you are assigned to receive trastuzumab deruxtecan (also called T-DXd or DS-8201a), this medication will be given through a vein as an intravenous infusion.
The medication is administered as a solution that is infused slowly into your vein over a period of time.
Step 4
Treatment phase - Option B: Standard chemotherapy
If you are assigned to receive standard chemotherapy, you will receive a combination of carboplatin and paclitaxel. Both medications are given through a vein as intravenous infusions.
Alternatively, you may receive a combination of cisplatin and docetaxel, also given as intravenous infusions or injections.
The specific combination will be determined based on what is considered standard care and your doctor's judgment.
Some patients receiving standard chemotherapy may also receive radiotherapy (radiation treatment) as part of their treatment plan.
Step 5
Monitoring during treatment
Throughout the treatment period, you will have regular check-ups and tests to monitor your health and any side effects.
These monitoring visits will include vital signs measurements, blood tests to check organ function, heart function tests using echocardiogram or MUGA scan (tests that create images of your heart), and electrocardiograms (tests that measure the electrical activity of your heart).
Eye examinations will also be performed to check for any vision-related side effects.
You will be asked to complete questionnaires about your quality of life and any symptoms you may be experiencing.
Step 6
Disease monitoring
During and after treatment, imaging scans will be performed regularly to check whether the cancer has returned.
These scans will be reviewed both by your local medical team and by independent experts to assess whether there is any sign of cancer recurrence in the local area, nearby regions, or distant parts of the body.
If there is any suspicion of cancer returning, tissue samples may be taken to confirm the diagnosis.
Step 7
Long-term follow-up
After completing treatment, you will continue to be followed for an extended period.
The trial is expected to continue until February 2032, which means you may be monitored for several years to assess the long-term effectiveness of the treatment and your overall survival.
During this time, information will be collected about any cancer recurrence, your overall health status, and survival.

Who can join the trial?

17 criteria

You must sign and date the consent forms before starting any study procedures, including tissue testing for HER2 (a protein found on some cancer cells)
You must be free of disease with no signs of cancer in the area where it started or spread to other parts of the body after surgery, confirmed by imaging scans
You must start the study treatment within 8 weeks after your endometrial cancer surgery
You must not have received any previous treatment for endometrial cancer, including radiation therapy, chemotherapy, immunotherapy, hormonal therapy, or heated chemotherapy during surgery
Your heart function must be normal, with a left ventricular ejection fraction (a measure of how well your heart pumps blood) of at least 50 percent, tested within 28 days before joining the study
Your ECOG performance status (a measure of how well you can perform daily activities) must be 0 or 1, meaning you are fully active or have some symptoms but can do light work, tested within 14 days before joining the study
Your organs and bone marrow must be working well enough, confirmed by blood tests done within 14 days before joining the study
You must wait the required time period after any previous treatments before joining the study
You must be willing and able to attend all scheduled visits, take the study medication as planned, complete laboratory tests, and follow all study requirements
You must be at least 18 years old when you sign the consent form
You must have a confirmed diagnosis of epithelial endometrial carcinoma (a type of cancer that starts in the lining of the uterus), proven by examining tissue under a microscope. Most types are allowed except sarcomas, although carcinosarcomas are permitted
You must be newly diagnosed with FIGO 2023 Stage IIC or Stage III disease (a classification system that describes how advanced the cancer is)
Your cancer must show HER2-expression (a high level of the HER2 protein) with a score of 3+ or 2+ on testing, confirmed by the central laboratory
You must have enough stored tumor tissue from your surgery available for testing of HER2 status by the central laboratory
You must have a test result for MMR (mismatch repair proteins that help fix errors in DNA) from your local laboratory using an approved test
You must be suitable to receive combination treatment with carboplatin and paclitaxel (two chemotherapy medications) as follow-up therapy after surgery
You must have had surgery intended to remove all cancer that included removal of the uterus and both ovaries and fallopian tubes. Removal or sampling of lymph nodes in the pelvis and abdomen is optional but recommended

Who cannot join the trial?

3 criteria

The study does not include male patients, only female patients can participate
Patients who do not have HER2-expressing endometrial cancer cannot participate. HER2 is a protein found on the surface of some cancer cells, and endometrial cancer is cancer of the lining of the uterus. The cancer must show specific levels of this protein, measured as IHC 3+ or 2+, which is determined through laboratory testing of tissue samples
Patients outside the specified age range for this study cannot participate

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Verified sites

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Responsive
Azienda Ospedaliera Ordine Mauriziano Di Torino
Turin, Italy
Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain

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Investigated drugs

Trastuzumab Deruxtecan
is a targeted cancer treatment that works by attaching to a protein called HER2 found on some cancer cells. It delivers chemotherapy directly to these cancer cells to help destroy them. This medication is given through an infusion into a vein.
Standard of Care Chemotherapy
refers to the usual chemotherapy treatment that doctors typically use for this type of cancer. These are medications that work to kill fast-growing cancer cells throughout the body. The specific chemotherapy drugs used may vary based on what is considered the best standard treatment.
Radiotherapy
is a treatment that uses high-energy rays to destroy cancer cells. It may be used together with chemotherapy in some patients as part of the standard treatment approach. The radiation is carefully directed at areas where cancer cells may be present.

What is already known about the treatment

Trastuzumab Deruxtecan – This medication is given as an infusion into a vein and is currently being studied in clinical trials for treating certain types of endometrial cancer that have high levels of a protein called HER2 on their surface. It works by attaching to the HER2 protein on cancer cells and delivering a powerful chemotherapy drug directly into those cells, which helps destroy them while limiting damage to healthy cells. This medicine belongs to a class of drugs called antibody-drug conjugates, which combine targeted therapy with chemotherapy to fight cancer more precisely.

Investigated diseases

Endometrial Cancer – Endometrial cancer is a type of cancer that begins in the lining of the uterus, called the endometrium. It occurs when cells in this tissue start to grow abnormally and uncontrollably. The cancer can spread locally within the uterus and may extend to nearby tissues such as the vagina, pelvis, or pelvic lymph nodes. As the disease progresses, it can develop into distant metastasis, meaning it spreads to other parts of the body beyond the pelvic region. In this particular study, the focus is on endometrial cancer that expresses a specific protein called HER2 on the surface of cancer cells. The disease can recur after initial treatment, either in the same area where it started or in distant locations.