NEPTUNE
Research type
Research Study
Full title
NEPTUNE: Enhancement of immuNothEraPy combining avelumab and repeaT doses of radiUm-223 in ER+ve, HER2-ve metastatic breast caNcEr.
IRAS ID
251515
Contact name
Jamie Oughton
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Eudract number
2018-003620-37
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
NEPTUNE is a study of patients with breast cancer that has spread to their bones. It will look at the safety and efficacy of treatment with avelumab and radium-223. All of the participants will be female patients attending selected NHS hospitals who have already had at least two different treatments for their cancer after it has spread to their bones.
About 70% of patients with advanced breast cancer will have the cancer spread to their bones, and the current treatments for these patients have relatively modest benefits and can cause a lot of side effects. If this trial finds this new treatment combination is effective, it may give these patients another treatment option that could have more benefits or less side effects.
These treatments have not been used together or on breast cancer patients before, but there is evidence that both radium-223 and avelumab are effective at treating other cancers. Avelumab helps the immune system fight the cancer and radium-223 binds to bones and kills cancer cells.
This study has two parts, or phases and participants will only take part in one phase. The first phase is a safety phase, where 6 patients will be recruited and treated with both avelumab and radium-223. They will be monitored closely to ensure the dosages of the drugs are safe and do not produce significant side effects. If the dosages are safe, there will then be an expansion phase, where 36 patients will be recruited and randomly allocated to receive either avelumab alone or avelumab and radium-223 together. The expansion phase will show researchers whether using radium-223 has an effect on the response of the cancer to avelumab.
The treatment will last up to 26 weeks, with avelumab being given once every two weeks and radium-223 being given once every 4 weeks.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
19/SC/0536
Date of REC Opinion
31 Oct 2019
REC opinion
Favourable Opinion