A phase 2, open-label, Multicenter, Randomized study of Trastuzumab Deruxtecan versus investigator’s choice chemotherapy in recurrent ovarian cancer that progressed on prior PARP inhibitor therapy: TROY (APGOT-OV14)
Ovarian cancer can sometimes return after initial treatment, including after taking targeted medicines known as PARP inhibitors. When this happens, doctors need better, more effective treatment options. This trial is testing a medicine called trastuzumab deruxtecan (brand name Enhertu) to see how well it works compared with standard chemotherapy. Enhertu is a type of targeted therapy designed to find cancer cells carrying a specific protein called HER2. Once attached to these cells, it delivers a dose of chemotherapy directly inside them. The trial is open to women aged 18 and over whose ovarian cancer has returned and whose tumours show some level of the HER2 protein. Researchers want to see if Enhertu can delay cancer growth, shrink tumours, and improve quality of life compared to standard treatments.
At a glance
What is this study about?
Ovarian cancer is one of the most common gynaecological cancers. While initial treatments often help bring the cancer under control, it can sometimes come back. Many patients receive maintenance treatments called PARP inhibitors to delay the cancer's return. However, if the cancer begins to grow again after these medicines, finding the next effective treatment can be challenging.
This phase 2 trial, called the TROY study, is testing a newer targeted treatment called trastuzumab deruxtecan (Enhertu). Enhertu is known as an antibody-drug conjugate. You can think of it like a guided missile: an antibody tracks down a protein called HER2 on the outside of the cancer cell, and then drops a powerful cancer-killing medicine directly into the cell. This helps attack the tumour while trying to spare more healthy tissue.
Participants in the trial will be randomly chosen to receive either Enhertu or a standard chemotherapy selected by their study doctor (which may include a medicine called Avastin). Researchers will closely monitor both groups using regular scans to measure how well each treatment works.
The main goal of this study is to see how long patients can live without their cancer getting worse (known as progression-free survival). By comparing Enhertu with standard chemotherapy, doctors hope to discover whether this targeted medicine could become a valuable new treatment option for ovarian cancer in the future.
Key takeaways
- The trial tests whether the targeted medicine Enhertu works better than standard chemotherapy for recurrent ovarian cancer.
- It is designed for women whose cancer has returned after treatment with a PARP inhibitor.
- Tumours must test positive for some amount of the HER2 protein to qualify.
- Participants will be randomly assigned to receive either Enhertu or standard chemotherapy.
- All medicines are given through a drip at the hospital alongside regular scans and check-ups.
Who may be eligible?
This trial is for adult women aged 18 and older who have been diagnosed with ovarian cancer that has returned or worsened after previous therapy. To take part, you must have previously received a type of targeted drug called a PARP inhibitor.
Your tumour must also show the presence of a protein called HER2. Doctors can check for this by testing a small sample of tumour tissue that was taken during a previous surgery or biopsy. Even low or medium levels of this protein may mean you are able to take part.
You will also need to be reasonably active and well enough to attend hospital visits, have blood tests, and receive intravenous treatments. Your doctor will review your full medical history, including heart and lung health, to make sure the trial medicines are safe for you.
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.
- I am a woman aged 18 or older.
- I have been diagnosed with ovarian cancer that has returned or progressed.
- I have previously been treated with a PARP inhibitor medicine.
- I am willing to have my tumour tissue tested for the HER2 protein.
- I am well enough to travel to regular hospital appointments and scans.
What does participation involve?
If you decide to join this trial, you will be randomly assigned by a computer to receive either Enhertu or standard chemotherapy chosen by your doctor. Neither you nor your doctor can pick which group you are in, though everyone receives an active cancer treatment.
Both treatments are given as an infusion (a slow drip into a vein) at a hospital day clinic, usually once every few weeks. Before each treatment, you will have blood tests and a physical check-up to make sure you are feeling well enough for your dose. You will also have regular imaging scans, such as CT or MRI scans, roughly every few weeks to monitor how the cancer is responding.
You can stay on the trial treatment for as long as it continues to help you and the side effects remain manageable. If the cancer grows or if you experience troublesome side effects, your study doctor will discuss other treatment options with you.
Potential risks and benefits
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Common questions
What is Enhertu and how does it work?
Enhertu (trastuzumab deruxtecan) is a targeted cancer medicine. It attaches to a protein called HER2 found on some cancer cells and delivers a strong dose of chemotherapy directly into them.
Will I definitely receive the new medicine?
Not necessarily. This is a randomised trial, which means a computer randomly decides whether you receive Enhertu or standard chemotherapy chosen by your specialist doctor.
What does HER2-positive or HER2-expressing mean?
HER2 is a normal protein that helps cells grow, but some cancer cells produce too much of it. The trial tests your tumour to see if any HER2 is present, as Enhertu needs this protein to find the cancer cells.
How often will I need to visit the hospital?
You will usually need to visit the hospital every few weeks for your treatment drip, routine blood tests, and health checks. Scans are typically done every few months.
Can I leave the study if I change my mind?
Yes. Joining a clinical trial is entirely voluntary. You can choose to stop taking part at any time, and your doctor will continue to offer you the best standard care available.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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