Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer
This study aims to discover better treatments for advanced breast cancer that has become resistant to common hormone therapies (CDK4/6 inhibitors). Doctors want to use blood tests, sometimes called "liquid biopsies," to look for specific DNA changes in your cancer. These changes, known as biomarkers, could help predict which new medications or drug combinations might work best for you. The study involves several different drugs, including RP-6306, Gemcitabine, Niraparib, Fulvestrant, RP-3500, CFI-402257, CFI-400945, and Sacituzumab govitecan, testing them in small groups to see their effects. The goal is to move towards more personalised treatment, ensuring patients receive the medicines most likely to help them.
At a glance
What is this study about?
This study is designed to explore new treatment options for a specific type of advanced breast cancer. This is for people whose cancer has grown despite having received initial hormone therapy, often with a type of drug called a CDK4/6 inhibitor, which is a common first-choice treatment. When this initial treatment stops working, doctors need new ways to fight the cancer.
The main idea behind this study is to use advanced tests on your blood or, occasionally, on a piece of your tumour. These tests look for tiny changes in the cancer's DNA, called 'biomarkers'. The hope is that by identifying these unique biomarkers, doctors can better predict which of the new, experimental drugs or drug combinations will be most effective for you. This approach is all about trying to find a more personalised way to treat your cancer, rather than a one-size-fits-all approach.
The study involves several different experimental drugs and combinations. There isn't just one treatment route; instead, based on your test results, you might be offered one of several different treatment paths within the study. This is a Phase 2 study, which means it's testing these drugs and combinations in a larger group of people to see if they are safe and effective, following earlier tests that showed promise. The information gathered from this study could help doctors make more informed treatment decisions for people with this type of breast cancer in the future.
Key takeaways
- This study explores new treatments for advanced ER+/HER2- breast cancer that stopped responding to initial hormone therapy.
- It uses 'liquid biopsies' (blood tests) to find specific cancer markers to guide treatment choices.
- Several experimental drugs and combinations are being tested.
- The goal is to find more personalised and effective treatments.
- You must have clear signs of cancer on scans and have received previous CDK4/6 inhibitor therapy for at least 6 months.
Who may be eligible?
To join this study, you must have advanced breast cancer that has spread to other parts of your body, and it must be a type that tests positive for oestrogen receptors (ER+) and negative for HER2. Crucially, your cancer must have grown or gotten worse while you were on, or shortly after stopping, an initial hormone therapy that included a CDK4/6 inhibitor, and you must have received this previous treatment for at least 6 months.
Doctors will also need to review a sample of your tumour tissue from a previous biopsy. You need to be at least 18 years old, generally well enough to take part with a good daily activity level (ECOG performance status 0 or 1), and doctors expect you to live for at least 3 more months. Specific blood test results for your kidneys, liver, and blood counts also need to be within a healthy range.
Finally, the doctors will need to see clear evidence of your cancer on scans and be able to measure it accurately. If your cancer is localised, meaning it hasn't spread and can be cured with surgery or other treatments, this study would not be suitable 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.
- Do I have advanced breast cancer that has spread?
- Is my breast cancer ER+ and HER2-?
- Has my cancer grown or worsened after initial hormone therapy (with a CDK4/6 inhibitor) that I took for at least 6 months?
- Am I at least 18 years old?
- Am I generally well and able to carry out most daily activities?
- Do I have recent scans showing my cancer that can be measured?
What does participation involve?
If you join this study, you will first have a screening period where doctors will take blood samples or existing tumour samples to check for specific markers that determine which treatment group you might fit into. If you are eligible, you will then receive one of the study treatments which could involve taking medication, getting injections, or having infusions. The exact schedule will depend on the specific treatment you are assigned to.
You will have regular hospital visits for check-ups, blood tests, and scans to monitor how you are responding to the treatment and to check for any side effects. You might also be followed to watch for any changes in your cancer before starting any treatment in the study. The total duration of your participation will depend on how your cancer responds to the treatment and the specific part of the study you are in, but it is likely to involve ongoing treatment and monitoring for a period.
Potential risks and benefits
Locations (10)
- Arthur J.E. Child Comprehensive Cancer CentreVerified postcodeCalgary, Canada· Recruiting
- BCCA - KelownaVerified postcodeKelowna, Canada· Recruiting
- BCCA - VancouverVerified postcodeVancouver, Canada· Recruiting
- QEII Health Sciences CentreVerified postcodeHalifax, Canada· Recruiting
- Juravinski Cancer Centre at Hamilton Health SciencesVerified postcodeHamilton, Canada· Recruiting
- Kingston Health Sciences CentreVerified postcodeKingston, Canada· Recruiting
- Ottawa Hospital Research InstituteVerified postcodeOttawa, Canada· Recruiting
- Odette Cancer CentreVerified postcodeToronto, Canada· Suspended
- University Health NetworkVerified postcodeToronto, Canada· Recruiting
- The Jewish General HospitalVerified postcodeMontreal, Canada· Recruiting
Common questions
What does ER+/HER2- mean?
This describes a specific type of breast cancer. ER+ means the cancer cells have receptors for oestrogen, and HER2- means they don't have too many HER2 receptors. This helps doctors decide the best treatments.
What is a 'liquid biopsy'?
A liquid biopsy is a blood test that can find tiny pieces of cancer cells or DNA in your blood. It's less invasive than a traditional biopsy and can give doctors information about your cancer.
What is a CDK4/6 inhibitor?
CDK4/6 inhibitors are a type of drug commonly used to treat ER+ breast cancer, often alongside hormone therapy. They work by blocking proteins that help cancer cells grow.
Will I know which treatment I'm getting?
Yes, if you're eligible for a treatment arm of the study, the doctors will inform you about the specific experimental drug or combination you will receive.
What if my cancer is getting worse and I'm not on a treatment yet?
There is a monitoring part of the study for people whose cancer hasn't progressed yet. You could be followed until your cancer does progress, at which point you might be eligible for one of the experimental treatment groups if the biomarker tests allow.
How to find out more
Lesley Seymour
Always speak to your GP or specialist before deciding to take part in a study.
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