24 September 2021

A new clinical trial could bring hope to thousands of UK women living with incurable secondary breast cancer, also known as metastatic or Stage 4 breast cancer.

Two drugs that are already being used separately in the treatment of some prostate, renal and skin cancers will now be tested in combination for the first time to treat breast cancer, to see if they improve outcomes for women with oestrogen receptor positive HER2 negative breast cancer that has spread to other parts of the body.

Secondary breast cancer occurs when breast cancer cells spread from primary cancer in the breast, through the lymphatic or blood system to other parts of the body. Actual numbers are not yet known, but estimates suggest 35,000 people in the UK are living with incurable secondary breast cancer, and the fear and uncertainty around when the disease will cut their lives short.

Funded by The Breast Cancer Now Catalyst Programme, this study aims to accelerate progress in world-class breast cancer research through innovation and collaboration. As part of the Programme, Pfizer have provided Breast Cancer Now with funding through an independent medical research grant and given the charity’s researchers access to several Pfizer medicines.

Led by Professor Janet Brown at the University of Sheffield, and run by the Clinical Trials Research Unit at the University of Leeds, the study team will give radium-223 and avelumab to patients with breast cancer that has spread to other parts of their body, including the bones. The researchers will then analyse if this combination produces an improved immune response to secondary breast cancer in the bone and other sites in the body, causing tumours to shrink. Avelumab is currently used to treat some forms of secondary renal, advanced bladder and secondary skin cancers, whilst radium-223 is used to successfully treat prostate cancer when it spreads to the bones.

While 99% of women diagnosed with breast cancer at Stage 1 survive for five years or more following diagnosis, this figure drops to just 27% for women diagnosed with secondary breast cancer which is why new breakthroughs in research are desperately needed.

Professor Janet Brown, Chair in Medical Oncology and Professor of Translational Medical Oncology at the University of Sheffield said:

“Although radium-223 and avelumab are approved for treatment of other cancers, they have not been previously used in combination for breast cancer patients. We hope that this trial will see this combination treatment improve the immune response to secondary breast cancer in the bones and other sites in the body, as earlier research has suggested it could.

“This trial is an exciting chance to see if we can make immunotherapy work better, causing tumours in the bone and other secondary sites to shrink, which would significantly improve outcomes for people with secondary breast cancer.”

Dr Simon Vincent, Director of Research, Support and Influencing at Breast Cancer Now, said:

“When breast cancer spreads to another part of the body it becomes incurable. We desperately need to find new and effective treatments for the thousands of women living with this devastating disease.

“Professor Brown’s research trial is particularly promising as both radium-223 and avelumab are already used to treat people with other types of cancer. If successful, we will then see the drug combination tested in larger trials, and our ultimate hope is that it could improve chances of survival for people with secondary breast cancer in the future.

“This trial is one of many exciting research projects being funded by The Breast Cancer Now Catalyst Programme. Charity-funded medical research has been served a huge blow by both Brexit and the COVID-19 pandemic, but through this Programme we are continuing to accelerate progress in world-class breast cancer research.”

The immune system plays an important role in destroying cancer cells, but cancer cells can evade the immune system to survive. Immunotherapies, like avelumab, are medicines that help the immune system to recognise and attack cancer. Avelumab, a medicine jointly developed and commercialised by Merck and Pfizer, is an immunotherapy drug called a PD-L1 inhibitor, which blocks the PD-L1 protein which is found on some cancer cells. The PD-L1 protein decreases the immune system’s ability to kill cancer cells, so by blocking the PD-L1 protein the immune system can be stimulated to recognise and destroy cancer cells.

Radiotherapy can improve the immune system’s response to immunotherapy, but it is difficult to target radiotherapy only to tumours in the bones. Radium-223 is different to conventional radiotherapy as the radioactive drug is absorbed by bone cells, meaning it delivers the treatment closer to where it is needed inside the body near to the tumour. If successful, this combination of drugs could provide a new way to treat secondary breast cancer.

Adele Gatley, 56, from Cheshire, is living with secondary breast cancer. She was first diagnosed breast cancer in 2020, but in January 2021 a scan showed that the cancer had spread to her lungs:

“I know that every breast cancer is not the same, but I know my version is aggressive. I have a history of breast cancer in my family, so I always half expected it, but I didn’t expect this diagnosis.

“I was given the ‘all clear’ at a mammogram in April 2020, but went to see my GP in November as I knew something wasn’t right as my nipple was different on my left breast. I was first diagnosed with grade 3 triple negative breast cancer, but a CT scan then showed it had spread to my lungs.

“I’m on a three-weekly treatment cycle at The Christie hospital – I have an immunotherapy drug then two chemotherapy drugs one week.  The second week is just chemotherapy and then I get a week off.

“You can live well with incurable breast cancer but no-one should have to – we badly need more new treatment options for women like me. It’s crucial that research trials like this one from The Breast Cancer Now Catalyst Programme continue to be funded so that treatments can be found to stop breast cancer becoming incurable.”

The immunotherapy drug avelumab will also be trialled in a recently announced study, also part of The Breast Cancer Now Catalyst Programme, combining the drug with aspirin as a potential treatment for triple negative breast cancer.

For more information on The Breast Cancer Now Catalyst Programme visit breastcancernow.org/catalyst

ENDS

For more information or to arrange an interview, please contact the Breast Cancer Now press office at press@breastcancernow.org or on 07436 107914.

Notes to Editors

About Breast Cancer Now:

  • Breast Cancer Now is the UK’s first comprehensive breast cancer charity, combining world-class research and life-changing care.
  • Breast Cancer Now’s ambition is that, by 2050, everyone who develops breast cancer will live and be supported to live well.
  • Breast Cancer Now, the research and care charity, launched in October 2019, created by the merger of specialist support and information charity Breast Cancer Care and leading research charity Breast Cancer Now.
  • Visit breastcancernow.org or follow us on Twitter or on Facebook.
  • Anyone looking for support or information can call Breast Cancer Now’s free Helpline on 0808 800 6000.