The NIHR-funded PERSEPHONE trial found that 6 months’ treatment with Herceptin (trastuzumab) for women with HER2-positive early breast cancer was as effective as 12 months’ treatment. Shorter treatment led to fewer side effects and hospital visits and was linked to significant cost savings for the NHS.
Published: 16 May 2024
Breast cancer treatment linked to serious side effects
Breast cancer is the most common type of cancer in the UK, with around 55,000 people being diagnosed every year. Up to 1 in 5 of those people have HER2-positive breast cancer. This type of cancer tends to grow faster, spread and recur more often than other types.
Women with early stage HER2-positive breast cancer usually take an anti-cancer drug, known as Herceptin (trastuzumab), for 12 months after receiving chemotherapy. This reduces the chance of the cancer returning but it may cause dangerous side effects, such as heart failure.
In the largest trial of its kind, the NIHR awarded the PERSEPHONE trial £2.6 million to investigate whether the length of treatment, and therefore the risk of side effects, could safely be halved to only 6 months.
Halving treatment length reduces side effects
Led by Honorary consultant medical oncologist, Professor Helena Earl, the University of Cambridge team worked alongside the NIHR Clinical Trials Unit at the University of Warwick to recruit over 4,000 women for treatment.
Published in The Lancet, their results showed that taking trastuzumab for 6 months was as effective as 12 months for many women. After both 6 and 12 months of treatment, 9 out of 10 women were still free of breast cancer 4 years later.
While the outcomes were very similar, cutting the treatment to only 6 months resulted in fewer severe side effects, including heart problems, fewer hospital visits and significant cost savings of £9,537 per patient for the NHS.
"The trial would not have been possible without support from the NIHR Clinical Research Network for the 152 teams at centres throughout the UK who recruited patients".
- Professor Helena Earl, lead researcher for PERSEPHONE
Professor Janet Dunn led the trial at the NIHR Clinical Trials Unit and added: “The NIHR is a great funder for these types of trials as they ultimately refine treatment for patients with the maximum patient benefit ensured.”
Adding to the evidence base for clinical decision making
In light of their findings, NICE reviewed its existing breast cancer diagnosis and management guidance. Although it concluded that more evidence from further research was needed before changing the guidelines, NICE is optimistic that shorter treatment could benefit some patients who had a low risk of the cancer recurring.
In 2024, PERSEPHONE was also cited in the NIHR-supported Lancet Breast Cancer Commission (.PDF) and contributed to the report’s recommendations to tackle urgent global challenges in breast cancer.
Following PERSEPHONE, the NIHR funded several awards investigating how well trastuzumab works as a treatment for early HER2 breast cancer. One such study is the £1.6 million HER2-RADiCAL, which is recruiting women with early HER2-positive breast cancer.
Its aim is to see whether women (who have no cancer left after receiving trastuzumab before surgery) can receive much less trastuzumab after their surgery. In doing so, the researchers hope to reduce the serious long-term side effects of treatment.
The study was funded by the NIHR Health Technology Assessment (HTA) Programme and published in Health Technology Assessment.
More information about the study is available on the NIHR’s Funding & Awards website.
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