Identifying more harm than good: The PRIMETIME breast cancer study

PRIMETIME is a research study in early breast cancer investigating whether it’s possible to identify a group of women with a very low risk of recurrence of their cancer, who can safely avoid radiotherapy. It was developed with support, including reviews from experts from our CTRad initiative at a radiotherapy trial proposals meeting. For women with a very low risk of recurrence of their cancer, the researchers anticipate that the side effects of radiotherapy would outweigh the benefits.

This study involves avoiding a treatment that would normally be given as standard, and participation relies heavily on the concept of weighing up risks and benefits of treatments. Patient involvement was crucial in designing this study to ensure that patients would be properly supported and to explain the study and risks involved*.

Lesley and Hilary, NCRI Consumers (people affected by cancer) who partnered on the development of this study, explain the importance of their involvement, “Our involvement was essential because only patients can bring the perspective of patients. A decision to enter this study requires patients at low risk of recurrence to understand the benefits and risks of radiotherapy for them.

“As breast cancer patients ourselves we have an understanding of how we approached the decisions which have to be made. We also explained that not every patient understands the concept of absolute and relative risk and worked with the team to make patient decision aids clearer.”

A previous application for funding was unsuccessful, so the researchers were developing a new study design, partnering with Consumers to improve this. Lesley and Hilary’s input at this very early stage helped to refine the design of the trial to improve recruitment while clearly communicating risk and benefits and the trial was successfully funded with this new design**.

Dr Charlotte Coles, Chief Investigator on the study, explains how patient involvement has benefitted a wide range of areas within the study: “Consumers, as integral members of the team, have had an impact on PRIMETIME at every stage from study design, protocol development to design of patient decision aids to supplement the patient information sheet and enhance understanding.”

Although the study is still in its early stages, it is hoped that it will ultimately impact on the care that women with early breast cancer receive.

“We hope that the study will change practice in the UK and internationally by identifying a group of women, who will still have excellent outcomes without the need for radiotherapy. The biomarker-directed test used in this study is inexpensive and could be used widely to help women and their clinicians make a much more fully informed, personalised decision about the benefits and risks of radiotherapy for them so that one size no longer fits all.” Say Lesley and Hilary.

Involving patients through all stages of study design, and including them as partners on the study team, is crucial to improve studies – and, potentially, the treatments that people with cancer receive. This is why the NCRI involves Consumers across its work and supports Consumers to become involved in studies like this.


*For PRIMETIME this involvement was supplied through Independent Cancer Patients’ Voice by its members, Lesley Turner of the NCRI Supportive and Palliative Care CSG and Hilary Stobart who was a CTRad consumer representative and also sits on the NCRI Breast CSG.

** This new trial design was funded by Cancer Research UK, with sponsorship by the Institute of Cancer Research, and the PRIMETIME study is now underway.