6-month Herceptin course as effective for many breast cancer patients as 12, say University of Cambridge researchers

£2.6m study could help reduce side effects for patients and save costs for the NHS

A £2.6million study has found that a breast cancer drug could be as effective at saving lives and preventing relapses if taken for six months as it is over 12.

The research, led by teams at the University of Cambridge and the University of Warwick, could help reduce side effects for women taking the drug and reduce costs for both patients and the NHS.

The introduction of Herceptin was a major breakthrough in breast cancer treatment, helping to prolong and save lives of the women with the HER2 receptor on the surface of their tumour cells.

About 15 per cent of women with early breast cancers are HER2 positive. Herceptin is a targeted therapy that attaches to the HER2 receptors preventing the cancer cells from growing and dividing.

It has become the standard treatment and a 12-month treatment course has been adopted based on clinical research. But a further study suggested a shorter duration could be as effective.

The new trial, called PERSEPHONE, was the largest study yet conducted on the impact of reducing the duration. Funded by the government’s National Institute for Health Research (NIHR) and featuring translational research funded by Cancer Research UK, more than 4,000 women were recruited.

It found that 89.4 per cent of patients taking six months’ treatment were free of disease after four years compared with 89.8 per cent of patients taking treatment for 12 months.

In addition, only four per cent of women on the six-month course stopped taking the drug early because of heart problems, compared with eight per cent in the 12-month group. Women also received chemotherapy – anthracycline-based, taxane-based or a combination of both – while enrolled in the trial.

Lead study author Professor Helena Earl, professor of clinical cancer medicine, University of Cambridge and Cancer Research UK Cambridge Centre, said: “The PERSEPHONE trials team, patient advocates who have worked with us on the study and our investigators are very excited by these results.

“We are confident that this will mark the first steps towards a reduction of Herceptin treatment to six months in many women with HER2-positive breast cancer.

“However, any proposed reduction in effective cancer treatment will always be complex and very challenging, and women currently taking the medication should not change their treatment without seeking advice from their doctor.

“There is more research to be done to define as precisely as possible the particular patients who could safely reduce their treatment duration. We are poised to do important translational research analysing blood and tissue samples collected within the trial to look for biomarkers to identify subgroups of different risk where shorter/longer durations might be tailored.”

Prof Hywel Williams, director of the NIHR health technology assessment programme that funded the study, said: “This is a hugely important clinical trial that shows that more is not always better. It is unlikely that research like this would ever be done by industry, so I am delighted that the NIHR are able to fund valuable research that has a direct impact on patients.”

Prof Charles Swanton, Cancer Research UK’s chief clinician, said: “This is a critically important study that the breast cancer field has been eagerly awaiting.

“Targeted therapies, while effective, come at a huge health economic cost to the NHS as well as potentially causing side effects such as heart problems.

“Despite years of research, we haven’t been able to establish the optimal duration of Herceptin treatment, either to delay cancer coming back or to cure patients with early HER2-positive breast cancer following surgery. By analysing tumour and blood samples, the researchers will now try to understand which patients can stop Herceptin at six months and which patients need extended therapy.”

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