[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer
This study is exploring a new way to treat advanced breast cancer that is hormone-sensitive (ER+) and HER2-negative, and also linked to a specific protein called GRPR. Researchers are testing a new radioactive drug called [177Lu]Lu-NeoB alongside two commonly used breast cancer medicines, ribociclib and fulvestrant. The main goal is to find the safest and most effective dose of this new combination. This trial is for patients whose cancer has either returned quickly after initial hormone therapy, or has worsened while on hormone therapy combined with another type of drug (CDK4/6 inhibitor). By combining these treatments, the study hopes to offer a new option for patients who haven't responded well to standard therapies, aiming to improve how specific cancer cells are targeted.
At a glance
What is this study about?
This clinical trial is designed to find improved ways to treat advanced breast cancer. Specifically, it focuses on breast cancer that has certain characteristics: it's sensitive to hormones (known as ER+), doesn't have too much of a protein called HER2 (HER2-), and also shows a specific protein called GRPR. We know that some breast cancers respond well to hormone-blocking treatments, but sometimes these treatments stop working, or the cancer comes back. This study aims to help those patients.
The researchers are testing a new medicine called [177Lu]Lu-NeoB. This drug is a type of targeted radiation therapy, meaning it's designed to deliver radiation directly to cancer cells that have the GRPR protein, hopefully sparing healthy cells. It's being given alongside two established breast cancer drugs: ribociclib (a CDK4/6 inhibitor) and fulvestrant (a hormone therapy). The idea is that combining these different types of treatments might be more effective than using them alone. The main purpose of this first phase of the study is to carefully figure out the right and safest dose of [177Lu]Lu-NeoB when used with ribociclib and fulvestrant.
To do this, a small group of patients will start on a lower dose, and if it's safe, the dose will be gradually increased in other small groups of patients until the best dose is found. This careful approach helps ensure patient safety while exploring the potential benefits of this new combination. Before starting the main treatment, patients will also receive a special scan using a similar, very low-dose substance called [68Ga]Ga-NeoB, which helps doctors see where the GRPR protein is in the body and if the targeted treatment will work.
Key takeaways
- Tests a new radiation drug with existing therapies.
- Aims to find the safest and most effective dose.
- For advanced, hormone-sensitive (ER+), HER2-negative, GRPR+ breast cancer.
- Targets patients whose cancer has progressed on prior hormone treatments.
- Involves regular clinic visits and specific scans.
- Participation is voluntary; you can withdraw anytime.
Who may be eligible?
This study is looking for both men and women who are at least 18 years old. To be considered, you must have advanced breast cancer that has spread locally or to other parts of the body, and isn't treatable with surgery or radiation aimed at a cure.
Your breast cancer must also meet specific criteria: it needs to be hormone-sensitive (this is called ER+ and means more than 10% of your cancer cells are ER positive). It also needs to be HER2-negative, which means it doesn't have too much of the HER2 protein. Importantly, your cancer must also have a protein called GRPR, which will be checked with a special scan. You would also have experienced your cancer coming back quickly after initial hormone treatment, or it has worsened while on hormone treatment combined with a CDK4/6 inhibitor for advanced disease.
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 at least 18 years old?
- Do you have advanced breast cancer that can't be cured by surgery/radiation?
- Has your breast cancer been tested and confirmed as hormone-sensitive (ER+) and HER2-negative?
- Has your cancer come back quickly after hormone therapy, or gotten worse on hormone therapy with a CDK4/6 inhibitor?
- Are you able to attend regular clinic visits for treatment and check-ups?
What does participation involve?
If you join this study, it starts with a screening phase where you'll have various tests, including a special scan using a very small amount of a substance called [68Ga]Ga-NeoB. This scan helps check if your cancer has the specific protein the new drug targets. The main treatment phase involves cycles lasting 28 days each, and you'll receive treatment for up to 6 cycles.
On the first day of each 28-day cycle, you'll receive the new radiation medicine, [177Lu]Lu-NeoB. You'll also take ribociclib tablets every day for the first 21 days of each cycle, and receive fulvestrant injections. Fulvestrant is given on specific days in the first cycle, and then once every 28 days after that. If you are a woman who still has periods or are a man, you will also receive goserelin on the first day of every cycle. Throughout the treatment period, you'll need to visit the study clinic approximately every 28 days for check-ups and to receive your medication. Additional scans might be done during your treatment and within 4-8 weeks after your last dose of [177Lu]Lu-NeoB. Treatment will continue until your cancer gets worse or you experience side effects that make you stop. The total duration in the study really depends on how you respond to the treatment.
Potential risks and benefits
Locations (25)
- UCLA Jonsson Comp Cancer CenterVerified postcodeLos Angeles, United States· Active not recruiting
- Hoag Memorial Hospital PresbyterianVerified postcodeNewport Beach, United States· Recruiting
- University of Kansas Medical CenterVerified postcodeWestwood, United States· Recruiting
- University of PennsylvaniaVerified postcodePhiladelphia, United States· Active not recruiting
- MD Anderson Cancer CenterVerified postcodeHouston, United States· Active not recruiting
- Utah Intermountain Medical CenterVerified postcodeMurray, United States· Active not recruiting
- Novartis Investigative SiteVerified postcodeGuangzhou, China· Withdrawn
- Novartis Investigative SiteVerified postcodeShanghai, China· Active not recruiting
- Novartis Investigative SiteVerified postcodeTianjin, China· Withdrawn
- Novartis Investigative SiteVerified postcodeSaint-Cloud, France· Active not recruiting
- Novartis Investigative SiteVerified postcodeBordeaux, France· Completed
- Novartis Investigative SiteVerified postcodeClermont-Ferrand, France· Active not recruiting
Common questions
What kind of breast cancer is this study for?
It's for advanced breast cancer that is hormone-sensitive (ER+), HER2-negative, and has a specific protein called GRPR.
What are the main medicines being tested?
The study combines a new targeted radiation drug ([177Lu]Lu-NeoB) with two established drugs: ribociclib and fulvestrant.
Why are they studying this combination?
Researchers want to find the safest and most effective dose of this new combination to offer a new treatment option for patients whose cancer has progressed after previous hormone therapies.
How long would I be on treatment if I join?
You would receive up to 6 cycles of treatment, with each cycle lasting 28 days. The total time in the study depends on how well you respond and if you have side effects.
Will I need special scans?
Yes, you'll have specific scans (PET/CT or PET/MRI) using a substance called [68Ga]Ga-NeoB before, possibly during, and after treatment to check your cancer and how it's responding.
How to find out more
Novartis Pharmaceuticals
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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