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 study about?

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.

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.

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Centre Antoine Lacassagne Nice France
Alexandra Hospital Athens Greece
Hospital Clinic De Barcelona Barcelona Spain
Hospital Da Luz S.A. Lisbon Portugal
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Alessandro Manzoni Hospital Lecco Italy
St. Luke’s Hospital S.A. Thessaloniki Greece
Mitera S.A. Athens Greece
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Azienda Sanitaria Locale Della Provincia Di Biella Ponderano Italy
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Hospital Universitario 12 De Octubre Madrid Spain
Unidade Local De Saude De Gaia/Espinho E.P.E. Vila Nova De Gaia Portugal
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Centre De Cancerologue Du Grand Montpellier Montpellier France
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Siedlce Poland
Azienda Ospedaliera Ordine Mauriziano Di Torino Turin Italy
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku Bialystok Poland
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Ospedale San Raffaele S.r.l. Milan Italy
Universita Degli Studi Di Brescia Brescia Italy
Servei De Salut De Les Illes Balears Palma Spain
Institut Sainte Catherine Avignon France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Centre Francois Baclesse Caen France
L’Hopital Prive Du Confluent Nantes France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Ksejvgbv Lgzey Ggkw Detmold Germany
Ihwu Gvtxh Filothei Greece
Bhbgifrx Udajqfkuhq Hwmzvlxw Ckdvgy Besançon France
Gbpgsg Udyqpuhyqk Frwkdkrcg Frankfurt Germany
Axkjgqr Upa Ioiit Dt Rvrpvk Eangbh Reggio Emilia Italy
Ukdfaoyczxoaqr Cxxomts Kargfhfzo Gdansk Poland
Ukjdjbjvzx Mfgfezq Cezsgx Hzejnljsegkgzowoc Hamburg Germany
Szxdaaiu Pnkbiqlkp Shc z osho Gdynia Poland
Aqmxouw Uluxw Svxsysoyb Lvpigr Ds Bljftmf Bologna Italy
Iladprhl Crgioa Ddjhmahzasmqdkbmq L'hospitalet De Llobregat Spain
Fgvsgrdxs Phfh Lm Iixemvwmbqmik Biqakmvxv Dnr Haeolmzb Uuisqpvgoalup Lu Pvj Madrid Spain
Kiprlksf Eulxfedpovpnesmpjehpzxfk Hhqsoazxtmnkhjoik Essen Germany
Ubjwrlhpwnjmeimseufgl Dqqbnhtqcvc Asc Duesseldorf Germany
Hxcfgmqu Vpvo dregiqfh Barcelona Spain
Cmvidp Olnxz Llcsoow Lille France
Hlyxmuaf Uacsspuknwmsw dx A Cwonfr A Coruna Galicia Spain
Hritbaxj Uaarmvwhsjvssm Sfpzuxyeov &cacaen Huznfpc du Hkdlwsobptk STRASBOURG, Alsace France
Cdksvw Hfgbfemkue E Uyrbmzfjqcluq Dc Cxcsvjt Ejpgau Coimbra Portugal

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
17.11.2025
Germany Germany
Not yet recruiting
17.11.2025
Greece Greece
Recruiting
17.11.2025
Italy Italy
Recruiting
17.11.2025
Poland Poland
Not yet recruiting
17.11.2025
Portugal Portugal
Recruiting
17.11.2025
Spain Spain
Recruiting
17.11.2025

Trial locations

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.

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.

Trial ID:
2024-519444-33-00
Protocol code:
DS8201-854
NCT ID:
NCT07022483
Trial Phase:
Therapeutic confirmatory (Phase III)

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