C4891024 - TACTIVE-U: AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL UMBRELLA STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT (ARV-471/PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH OTHER ANTICANCER TREATMENTS IN PARTICIPANTS AGED 18 AND OLDER WITH ER+ ADVANCED OR METASTATIC BREAST CANCER, SUB-STUDY C (ARV-471 IN COMBINATION WITH SAMURACICLIB)
This research study is for people aged 18 and older who have advanced or metastatic breast cancer. It's investigating a new treatment approach that combines two medicines: vepdegestrant (also known as ARV-471) and samuraciclib. Vepdegestrant is a new type of drug called a 'proteolysis targeting chimera', designed to specifically target and destroy cancer cells. The study is split into two main parts. The first part (Phase 1b) focuses on finding the safest dose of the combination and understanding any side effects. The second part (Phase 2) will then look at how well the combination treatment shrinks tumors or stops cancer from growing. Researchers will also check how the two drugs interact with each other in the body.
At a glance
What is this study about?
This study, called TACTIVE-U, is looking for better ways to treat advanced or metastatic breast cancer. Advanced or metastatic means the cancer has spread from where it started to other parts of the body. This type of cancer can be challenging to treat, so researchers are always looking for new and more effective options.
The study is focusing on a new medicine called vepdegestrant (also known as ARV-471). This drug belongs to a new group of medicines designed to specifically target cancer cells. It's being tested in combination with another medicine called samuraciclib. The aim is to see if using these two drugs together can be more effective than current treatments.
There are two main parts, or 'phases', to this study. The first part (Phase 1b) is like a careful first step, where doctors will closely watch for any side effects and work out the safest dose of the treatment combination. Once the best dose is found, the second part (Phase 2) will then focus on how well the treatment works to shrink or control the cancer.
Key takeaways
- Tests a new combination of two drugs (vepdegestrant and samuraciclib) for advanced ER+ breast cancer.
- Aims to find the safest dose and see how well the treatment works.
- Close medical monitoring and regular check-ups are part of participation.
- May offer a new treatment option for eligible patients.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To be considered for this study, you must be at least 18 years old. The study is open to both men and women.
You have to have advanced or metastatic breast cancer that is ER-positive. This means your cancer cells have receptors that respond to the hormone oestrogen, which is a common type of breast cancer.
There will be other detailed health requirements that your doctor will check to make sure the study is a safe and suitable option for you. These might include your general health, other medical conditions you have, and any previous treatments you've received.
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.
- Are you 18 years old or older?
- Do you have advanced or metastatic breast cancer?
- Has your doctor confirmed your breast cancer is ER-positive?
- Are you able to attend regular clinic appointments and follow study instructions?
- Are you willing to take two new investigational drugs as part of your treatment?
What does participation involve?
If you join this study, you will take both vepdegestrant and samuraciclib as prescribed by the study doctors. You will have regular visits to the clinic for medical check-ups, blood tests, and scans (like CT or MRI scans) to see how the treatment is working and to monitor your health. These visits will be more frequent at the beginning of the study and may become less frequent over time.
During these visits, doctors will monitor for any side effects, and adjustments to your treatment might be made if needed. You will be closely followed for a period of time to understand the long-term effects of the treatment, even after you stop taking the study drugs. The total duration of your participation will depend on how you respond to the treatment and the study's protocol, but it will involve multiple clinic visits over several months or longer.
Potential risks and benefits
Locations (4)
- —UnverifiedItaly
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedBelgium
Common questions
What kind of breast cancer is this study for?
This study is specifically for people with advanced or metastatic ER-positive breast cancer, meaning the cancer has spread and responds to oestrogen.
What are the new drugs being tested?
The study mixes two drugs: vepdegestrant (ARV-471) and samuraciclib. They are being tried together to see if they work better.
What does 'Phase 1b/2' mean?
This means the study has two parts. The first part (Phase 1b) finds the safest dose, and the second part (Phase 2) checks how well it treats the cancer.
Will I get better care in a study?
You will receive very close medical attention and monitoring throughout your participation, which can be reassuring.
Can I leave the study if I want to?
Yes, you can choose to leave the study at any time, without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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