A Phase I/II, open-label, multi-center trial of [177Lu]Lu-NeoB in combination with capecitabine in adult patients with gastrin releasing peptide receptor positive, estrogen receptor-positive, human epidermal growth receptor-2 negative metastatic breast cancer after progression on previous endocrine therapy in combination with CDK4/6 inhibitor
This clinical trial is studying a new treatment combination for adults with secondary (metastatic) breast cancer. It is designed for people whose cancer is estrogen receptor-positive (ER+) and HER2-negative, and has continued to grow after treatment with hormone therapy and a targeted drug called a CDK4/6 inhibitor. The trial tests Lutetium-NeoB, an experimental treatment known as radioligand therapy. It works like a guided missile, seeking out a specific protein on breast cancer cells to deliver radiation directly to them while sparing healthy tissue. Participants also take capecitabine, a standard chemotherapy tablet. The study aims to discover the safest dose of Lutetium-NeoB and find out how effectively it shrinks or stabilises tumours. Taking part lasts around six years in total, which includes approximately one year of treatment followed by five years of regular health checks.
At a glance
What is this study about?
Breast cancer is the most common cancer in the UK. A widespread type is ER-positive, HER2-negative breast cancer, which relies on hormones to grow. While hormone therapies combined with drugs called CDK4/6 inhibitors are effective at controlling this cancer, the cells often develop resistance over time. When these standard treatments stop working, doctors need new, targeted options to help patients manage the disease.
This trial investigates an innovative approach called radioligand therapy. The study drug, Lutetium-NeoB, attaches to a specific receptor (the GRPR protein) found on the surface of some breast cancer cells. By locking onto this protein, the drug delivers a small, targeted dose of radiation straight into the tumour. This is designed to kill cancer cells while minimising harm to healthy surrounding organs. The treatment is given alongside capecitabine, an approved oral chemotherapy already widely used in the NHS.
The study is divided into two phases. The first phase tests gradually increasing doses to establish the safest and most tolerable amount of Lutetium-NeoB. The second phase uses that chosen dose to evaluate how well the combination works at stopping tumour growth. Researchers will also use a specialised scan (Gallium-NeoB) to see how clearly it detects cancer cells. The goal is to provide a much-needed treatment alternative for patients whose cancer has progressed on standard therapies.
Key takeaways
- Tests a targeted radiation drip (Lutetium-NeoB) combined with chemotherapy tablets (capecitabine).
- Open to adults with ER-positive, HER2-negative secondary breast cancer.
- Aimed at patients whose cancer has grown after treatment with hormone therapy and a CDK4/6 inhibitor.
- Participation lasts around six years, including one year of treatment and five years of follow-up.
- Requires brief radiation safety precautions (such as social distancing) for up to a week after treatment.
Who may be eligible?
This trial is for men and women aged 18 and over who have advanced or metastatic breast cancer, meaning the cancer has spread from the breast to other parts of the body. Your tumour must be confirmed as estrogen receptor-positive (ER+) and HER2-negative.
To be eligible, your cancer must have grown or worsened during or after treatment with hormone therapy combined with a CDK4/6 inhibitor. You must not have had more than three separate hormone treatments for advanced cancer. You also need to have at least one tumour that can be accurately measured on a hospital scan.
You may not be able to take part if your tumour does not show the right markers, if your general health or organ function is poor, or if previous treatments rule you out. The trial team will carry out detailed checks, including blood tests and reviewing past tissue samples, to confirm whether this study is safe and 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.
- I am 18 years of age or older.
- I have been diagnosed with secondary (metastatic) breast cancer.
- My cancer is estrogen receptor-positive (ER+) and HER2-negative.
- My cancer has grown after receiving hormone therapy combined with a CDK4/6 inhibitor.
- I have had no more than three previous hormone therapy treatments for advanced breast cancer.
What does participation involve?
Taking part in the trial lasts around six years in total. This includes up to one year of active treatment followed by five years of follow-up health monitoring. During the treatment stage, you will receive Lutetium-NeoB as an intravenous drip into a vein in your arm, which usually takes about 10 minutes. You will also take capecitabine chemotherapy tablets at home. Throughout the trial, you will undergo regular hospital visits for CT or MRI scans, heart checks (ECGs), and blood and urine tests to monitor your health and safety. You will also have specialised PET scans using an imaging agent called Gallium-NeoB to see where the cancer cells are located. Once you finish treatment, the study team will continue to check on your health periodically.
Potential risks and benefits
Locations (1)
- -Approximate-, England
Common questions
Is Lutetium-NeoB an approved medicine?
No, Lutetium-NeoB is an experimental medicine. It is currently being tested in clinical trials and has not yet been approved for general prescription.
Will I be radioactive after receiving the treatment?
Yes, for a few days. You will emit a low level of radiation after each dose, so the medical team will provide clear safety instructions, such as keeping a short distance from others and washing hands thoroughly for up to seven days.
How is the medication given?
Lutetium-NeoB is given through a quick drip into a vein, which takes about 10 minutes. The other medicine, capecitabine, is taken as tablets by mouth at home.
Do I have to pay to take part in this trial?
No. The study drugs, tests, and scans are provided at no cost, and you may be reimbursed for reasonable travel expenses to and from the hospital.
Can I leave the study if I change my mind?
Yes. You have the right to withdraw from the trial at any point, for any reason, without your standard medical care being affected.
How to find out more
Cristiana Balcu
Always speak to your GP or specialist before deciding to take part in a study.
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