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RecruitingPHASE3INTERVENTIONAL

Study of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy for HER2-Expressing (IHC 3+/2+) Endometrial Cancer

This study is looking at women with specific types of womb cancer (endometrial cancer) where the cancer cells show high levels of a protein called HER2. After surgery, some women will receive a new medicine called trastuzumab deruxtecan (also known as Enhertu®), while others will have standard chemotherapy. Some women in both groups might also have radiotherapy. The main goal is to find out if the new drug can stop the cancer from returning for longer compared to traditional chemotherapy in these early stages. Researchers will also check for any side effects. This is a Phase 3 study, meaning it’s a later stage of research involving a larger number of patients to confirm the drug's effectiveness and safety.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Daiichi Sankyo
Enrolment target
710
Start
30 Sep 2025
Estimated completion
23 Mar 2032

What is this study about?

This research study is for women who have recently been diagnosed with a certain type of womb cancer, known as endometrial cancer. Specifically, it’s for those whose cancer cells have a lot of a protein called HER2. You might hear this described as being 'HER2-positive'. This protein can sometimes make cancer grow more quickly, so medicines that target it can be very helpful.

The study wants to compare a new medicine, trastuzumab deruxtecan (also known as Enhertu®), with the usual chemotherapy treatments and sometimes radiotherapy. All participants in the study will have recently had surgery for their cancer and haven't had any cancer treatment before this study. The aim is to see if the new medicine works better to stop the cancer from coming back after surgery and if it's safe to use.

Trastuzumab deruxtecan is a clever type of drug. Think of it like a guided missile: it has a part that specifically finds and attaches to the HER2 protein on cancer cells, and it also carries a powerful cancer-fighting medicine directly to those cells. This approach aims to kill cancer cells more effectively while hopefully causing fewer side effects to healthy cells. By taking part, you would be helping doctors understand the best ways to treat this specific type of womb cancer in the future.

Key takeaways

  • This study is for women with HER2-positive womb cancer after surgery.
  • It compares a new targeted drug (trastuzumab deruxtecan) with standard chemotherapy.
  • The main goal is to see which treatment best prevents cancer recurrence.
  • Participants will be randomly assigned to one of the treatment groups.
  • The study also looks at the safety and side effects of both treatments.
  • It's exploring a new way to treat specific types of womb cancer.

Who may be eligible?

This study is for women aged 18 or older who have been diagnosed with certain types of endometrial cancer. Your doctor will need to confirm that your cancer cells have high levels of the HER2 protein. This is very important for the study.

You would be eligible if your cancer is newly diagnosed and falls into stage IIC or III, which means it has spread a little locally or to nearby areas, but not widely to other parts of the body. You must have had surgery for your cancer, but no other cancer treatment yet, like chemotherapy or radiotherapy, for this particular cancer.

However, you wouldn't be able to join if your cancer has already come back, or if it's spread widely to distant parts of your body (Stage IV). You also can't take part if you have certain other conditions, like a recent heart attack or specific heart rhythm problems, or if you still have measurable cancer remaining after your surgery.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with endometrial (womb) cancer?
  3. Has your doctor confirmed your cancer is 'HER2-positive' (IHC 3+/2+)?
  4. Is your cancer newly diagnosed and Stage IIC or Stage III after surgery?
  5. Have you NOT received any prior cancer treatment (like chemo or radiotherapy) for this cancer?
  6. Do you have no other serious heart conditions or a history of recent heart attack?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to one of two groups, like flipping a coin. One group will receive the new medicine, trastuzumab deruxtecan, and the other will receive standard chemotherapy. Both groups might also have radiotherapy, depending on what your doctors recommend.

The study would involve regular visits to the hospital for your treatments, check-ups, and tests like blood samples and scans to see how you're responding and to check for any side effects. This will continue for a period after your treatment finishes to monitor your health. The duration of your treatment and follow-up will be discussed in detail by the study team, but generally, these types of studies involve consistent monitoring over several months or even a few years.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as access to a new treatment that isn't widely available yet, which could be more effective than standard options for your specific cancer. However, there are also potential risks, as new treatments can have side effects that are not fully known or can be more severe. Standard treatments also have known side effects. The study team will explain all known side effects for both options. You have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (61)

  • Broward Health Medical Center
    Verified postcode
    Fort Lauderdale, United States· Recruiting
  • Miami Cancer Institute
    Verified postcode
    Miami, United States· Recruiting
  • Mount Sinai Medical Center
    Verified postcode
    Miami Beach, United States· Recruiting
  • Trials365 LLC
    Verified postcode
    Shreveport, United States· Recruiting
  • FirstHealth of the Carolinas, Inc.
    Verified postcode
    Pinehurst, United States· Recruiting
  • University of Cincinnati Physicians Group, LLC
    Verified postcode
    Cincinnati, United States· Recruiting
  • Avera Medical Group Gynecologic Oncology Sioux Falls
    Verified postcode
    Sioux Falls, United States· Recruiting
  • Texas Oncology San Antonio Medical Center
    Verified postcode
    San Antonio, United States· Recruiting
  • Hospital Italiano de Buenos Aires
    Approximate
    Ciudad Autonoma Buenos Aires, Argentina· Recruiting
  • Sanatorio Allende Cerro
    Verified postcode
    Córdoba, Argentina· Recruiting
  • Centro de Investigaciones Medicas Mar del Plata
    Verified postcode
    Mar del Plata, Argentina· Recruiting
  • Beijing Cancer Hospital
    Verified postcode
    Beijing, China· Recruiting

Common questions

What is HER2-positive womb cancer?

It's a type of womb cancer where the cancer cells have a lot of a protein called HER2 on their surface. This protein can make the cancer grow and spread more quickly, and some medicines are designed to specifically target it.

What is trastuzumab deruxtecan (Enhertu®)?

It's a new medicine that's designed to specifically find cancer cells that have the HER2 protein and deliver cancer-killing medicine directly to them, aiming to be more effective and reduce harm to healthy cells.

Why is this study important?

This study is important because it’s comparing a new, targeted treatment with standard chemotherapy to see which is better at preventing early-stage HER2-positive womb cancer from returning after surgery, and if it's safe for patients.

Will I definitely get the new drug?

No, you have an equal chance of receiving either the new drug or standard chemotherapy, as participants are randomly put into groups, much like flipping a coin.

What does 'Phase 3 study' mean?

Phase 3 is a late stage of research where a new treatment is compared to existing standard treatments in a larger group of patients. It helps confirm if the new treatment works well and is safe before it can be made available more widely.

How to find out more

Contact for Trial Information

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Study of Trastuzumab Deruxtecan Versus Standard of Care Chem…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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