A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.
This study is for adults with advanced breast cancer that has spread to other parts of the body. Participants must have breast cancer that is hormone-sensitive (ER+) and HER2-negative, and it must have continued to grow despite previous hormone therapy combined with a CDK4/6 inhibitor medicine. The study aims to find the best and safest dose of a new treatment combining a type of targeted radiotherapy called [177Lu]Lu-NeoB with an existing chemotherapy called capecitabine. In the first part, we'll figure out the right doses. In the second part, we'll see how well this combination works to shrink or control the cancer. We hope this new approach will offer a valuable option for people whose cancer is no longer responding to current treatments.
At a glance
What is this study about?
When breast cancer spreads or comes back, it's called metastatic breast cancer. While current treatments, like certain hormone therapies combined with other drugs, can work very well for a while, the cancer can sometimes become resistant to them. This means the cancer starts growing again even with treatment, and doctors need to look for new options.
This study explores a new way to treat this type of advanced breast cancer. It combines two different approaches: a special type of targeted radiation therapy ([177Lu]Lu-NeoB) and a chemotherapy drug called capecitabine. The radiation therapy ([177Lu]Lu-NeoB) works by finding and attacking specific cancer cells that have a certain protein on their surface (called GRPR+). Capecitabine is a well-known chemotherapy that stops cancer cells from growing. By combining them, researchers hope to improve how well the treatment works.
This study has two main parts. The first part (Phase I) is about finding the safest and most effective dose of the radiation therapy when given with capecitabine. Once the best doses are found, the second part (Phase II) will then look at whether this combined treatment can shrink or stop the cancer from growing. The goal is to see if this new combination could be a useful treatment for people whose advanced breast cancer has stopped responding to other medicines.
Key takeaways
- This study tests a new combination of targeted radiation and chemotherapy for advanced breast cancer.
- It's for people whose hormone-sensitive, HER2-negative breast cancer has grown despite previous treatments.
- The study aims to find the right dose and see how well the new treatment works.
- Participants will have regular clinic visits and scans.
- Your safety and wellbeing will be closely monitored throughout the study.
Who may be eligible?
This study is looking for adults, aged 18 or older, who have advanced breast cancer that has spread. To be considered, your cancer must be hormone-sensitive (ER+) and HER2-negative. This means your cancer cells have certain markers that doctors check when they first diagnose your cancer.
Your cancer must have continued to grow despite having received previous hormone therapy in combination with a specific type of drug called a CDK4/6 inhibitor. You might also have had up to two other hormone therapies for your advanced cancer. It's important that your cancer can be measured on scans, so doctors can see if the treatment is working.
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 an adult aged 18 or over?
- Do you have advanced breast cancer that has spread?
- Is your breast cancer hormone-receptor positive (ER+) and HER2-negative?
- Has your cancer grown after receiving hormone therapy combined with a CDK4/6 inhibitor?
- Can your cancer be measured on scans?
What does participation involve?
If you decide to take part, you'll first have some scans, including a special PET scan using a tracer called [68Ga]Ga-NeoB. This scan helps doctors see if your cancer has the specific protein needed for the treatment to work. If you're in the second part of the study, you'll have another one of these scans after your last dose of the study drug.
During treatment, you'll visit the study clinic approximately every three weeks for the first nine months, and every six weeks after that. At these visits, you'll receive the study drugs, have tests to see how you're doing, and doctors will check on your safety. Tumor scans will be done periodically to see how your cancer is responding. The total length of your participation will depend on how you respond to the treatment.
Potential risks and benefits
Locations (33)
- UCLA Medical CenterVerified postcodeLos Angeles, United States· Recruiting
- Hoag Memorial Hospital PresbyterianVerified postcodeNewport Beach, United States· Recruiting
- Mayo Clinic - RochesterVerified postcodeRochester, United States· Recruiting
- Uni Of TX MD Anderson Cancer CntrVerified postcodeHouston, United States· Recruiting
- University Of WisconsinVerified postcodeMadison, United States· Recruiting
- Novartis Investigative SiteVerified postcodeDarlinghurst, Australia· Recruiting
- Novartis Investigative SiteVerified postcodeMalvern, Australia· Recruiting
- Novartis Investigative SiteVerified postcodeToronto, Canada· Recruiting
- Novartis Investigative SiteVerified postcodeMontreal, Canada· Recruiting
- Novartis Investigative SiteVerified postcodeGuangzhou, China· Active not recruiting
- Novartis Investigative SiteVerified postcodeTianjin, China· Recruiting
- Novartis Investigative SiteVerified postcodeBordeaux, France· Recruiting
Common questions
What kind of breast cancer is this study for?
This study is for advanced breast cancer that is hormone-sensitive (ER+) and HER2-negative, and has grown despite previous treatments, including a CDK4/6 inhibitor.
What are Erik and Lu-NeoB and Capecitabine?
[177Lu]Lu-NeoB is a new targeted radiation treatment that aims to find and attack specific cancer cells. Capecitabine is an existing chemotherapy medicine often used for breast cancer.
What happens before I start treatment in the study?
You'll have some initial tests, including a special scan called a PET scan, to see if your cancer is suitable for the targeted treatment.
How often will I need to visit the clinic?
For the first nine months, you'll visit about every three weeks. After that, it will be about every six weeks, depending on how long you stay on the study.
Can I stop participating in the study if I want to?
Yes, your participation is completely voluntary, and you can leave the study at any time without giving a reason.
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?
Discussion
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