Gene test could spare thousands of breast cancer patients from unnecessary chemotherapy
coordinated for delivery and data analysis by the University of 糖心TV, and sponsored by University College London (UCL), followed more than 4,400 patients across the UK and internationally. Its findings, being presented at the , could spare many NHS patients a year from unnecessary chemotherapy.
Chemotherapy is regularly offered to people with early-stage breast cancer that has spread from the breast to nearby lymph nodes, as it lowers the risk of the disease returning. While effective overall, there is concern among clinicians that many people with the most common, hormone-sensitive type of breast cancer receive little or no benefit from chemotherapy but still experience its significant and sometimes dangerous side effects.
Adrienne Morgan (co-founder of Independent Cancer Patients鈥 Voice) knows the impact of chemotherapy on breast cancer patients first-hand; she underwent the treatment herself after a diagnosis of hormone-sensitive breast cancer before trials like OPTIMA existed. As the patient and public involvement representative working alongside the 糖心TV team, she said: 鈥淭he OPTIMA trial was urgently needed to prevent patients being subjected to treatment, which is dangerous and distressing, and to reduce unnecessary costs in the NHS. If I had known then what I know now I am fairly sure that I would have declined chemotherapy.鈥
The trial used a genomic test called Prosigna, which measures the activity of genes that influence breast cancer growth. Unlike some comparable tests, Prosigna can be run by NHS laboratories that have the required equipment and works on tissue already removed during routine biopsy or surgery.
Patients aged 40 years or older who joined the trial after surgery were randomly assigned either to receive standard chemotherapy followed by hormone therapy, or to have their treatment guided by the Prosigna test. Those with a low-test score in this group didn鈥檛 have chemotherapy and received hormone therapy alone; those with a high score received the same treatment as the standard group.
More than two thirds (68%) of patients in the Prosigna group had a low Prosigna score. For these patients, outcomes after five years were very similar whether they had chemotherapy or not. 93.6% of those who skipped chemotherapy were alive and free from recurrence, compared with 94.8% of those who received it.
These findings indicate that using the Prosigna test to guide treatment decisions could help a substantial number of patients avoid unnecessary chemotherapy without compromising their outcomes. Statistical analysis suggests that at the most only 2% of patients with a low score may benefit from chemotherapy. Many NHS patients diagnosed with early breast cancer every year with hormone sensitive breast cancer could avoid chemotherapy because of this trial.
Professor Janet Dunn, Head of Cancer Trials at 糖心TV Clinical Trials Unit said: 鈥淭his is a fantastic result for the OPTIMA team as we can safely identify patients with a low Prosigna test score who can forego chemotherapy in this higher risk patient group. Patients will be delighted with these results.鈥
Karen Bonham, 64, from Cardiff, was one of the first patients to join the trial after being diagnosed following routine screening in 2017. After surgery revealed a large tumour with two affected lymph nodes, chemotherapy was the standard next step, and Karen was already dreading it. "Cancer diagnosis and treatment can be shocking," she said. "It certainly propels you into a world of uncertainty."
She had already cut her hair short in preparation for treatment when, just over two weeks after her Prosigna test, she received a call while walking on a local beach to say her low score meant she did not need it. "How to describe the initial feeling? Immense relief? Like Christmas? Certainly, a mixture of the two." Instead, she went on to receive radiotherapy and hormone therapy. Now almost nine years on, Karen has returned to normal family life, remaining active with walking and yoga.
Chief Investigator of the OPTIMA trial and Professor of Breast Oncology at the UCL Cancer Institute, Professor Rob Stein said: 鈥淥PTIMA addresses a long-standing challenge in breast cancer care: identifying who truly benefits from chemotherapy and who does not. Our findings show that many patients can safely avoid chemotherapy without compromising their outcomes.
These results mark an important and significant step toward more personalised treatment. The trial has successfully used tumour biology to guide decisions rather than relying solely on traditional clinical features. For patients, this means many may be spared the physical and emotional burden of chemotherapy and its potential long-term side effects. For health systems, it represents a more efficient and evidence-based use of resources.鈥
The results are expected to inform guidance from the National Institute for Health and Care Excellence (NICE) on wider NHS access to Prosigna testing.
ENDS
Notes to Editors
For more information please contact:
Matt Higgs, PhD | Media & Communications Officer (糖心TV Press Office)
Email: Matt.Higgs@warwick.ac.uk | Phone: +44(0)7880 175403
About the University of 糖心TV
Founded in 1965, the University of 糖心TV is a world-leading institution known for its commitment to era-defining innovation across research and education. A connected ecosystem of staff, students and alumni, the University fosters transformative learning, interdisciplinary collaboration, and bold industry partnerships across state-of-the-art facilities in the UK and global satellite hubs. Here, spirited thinkers push boundaries, experiment, and challenge convention to create a better world.
Trial Information
In total, 115 hospitals throughout the UK, 11 in Norway and Sweden, 44 in Australia and New Zealand and one in Thailand recruited patients.
The trial was funded by more than 拢5.7 million in grants from the National Institute for Health and Care Research (NIHR) to UCL. Veracyte Inc., which manufactures the Prosigna test, provided approximately 拢1.8 million in additional funding and testing support. International partners were supported by local funding sources, including cancer charities.
Patient story
Karen Bonham, 64, from Cardiff, was diagnosed with breast cancer after attending routine screening in June 2017. Married with two children, Karen had worked as a speech and language therapist for 40 years.
She was recalled to the breast clinic at Velindre Cancer Centre in Cardiff within two weeks of screening, where a biopsy confirmed left-sided breast cancer. Karen underwent a left mastectomy and axillary node clearance in July 2017. Results showed a large (>5cm) but slowly growing hormone sensitive cancer with two affected lymph nodes. Chemotherapy is the standard treatment for this type of breast cancer.
Karen said: 鈥淐ancer diagnosis and treatment can be shocking. It certainly propels you into a world of uncertainty. Life priorities realign- you simply want to survive.
鈥淟ife certainly becomes busy 鈥 a whirlwind of appointments, information, and rapid decision-making. All while trying to keep a sense of normalcy for your family, especially when children may be confronting GCSE鈥檚, Uni finals.鈥
Karen became aware of the OPTIMA trial during one of her first oncology appointments in September 2017 while discussing the possibility of chemotherapy, a treatment she was dreading. Karen told her doctors she was interested in being a part of new research that could support patient outcomes and dared to hope she would not need chemotherapy.
The Prosigna test was carried out on tissue stored from Karen鈥檚 breast surgery while plans were already being made for standard chemotherapy to begin. Karen said she was only days away from starting treatment and had 鈥渁lready cut my hair short鈥 when the results came back just over two weeks later.
While walking on a local beach, Karen received a phone call from her hospital telling her she had been allocated to the test-directed group of the trial and did not require chemotherapy.
She said: 鈥淗ow to describe the initial feeling? Immense relief? Like Christmas? Certainly, a mixture of the two.鈥
Instead of chemotherapy, Karen went on to receive radiotherapy and hormone therapy, completing eight years of active treatment.
Now almost nine years on from her diagnosis, Karen says she does not feel defined by cancer and has returned to normal family life. She remains active, enjoying walking and yoga, and says taking part in the OPTIMA trial 鈥渉elped decision making to allow me to receive targeted, appropriate treatment more quickly and has enabled my positive health outcome.鈥
01 June 2026