2 million people worldwide are diagnosed with breast cancer each year. As the world’s most prevalent form of the disease, treatment has previously focused on rounds of chemotherapy to shrink the tumours.
While in many cases chemotherapy has been found to be highly effective at eliminating cancer cells and reducing the risk of recurrence, its overall success rate can vary depending on the stage of cancer and the biological subtype of the breast cancer. Despite this, chemotherapy comes with a lot of challenging and toxic side effects, including hair loss, nausea, fatigue, insomnia, higher risk of infection and rashes in many patients.
 For decades, chemotherapy has been one of the most widely recommended options for patients with cancer. Now, a new study by scientists at University College London has developed a genomic test determining which patients are likely to benefit from chemotherapy and which may achieve better outcomes with hormone therapy instead.Â
Inside the Optima Clinical Trial
Results from the Optima clinical trial of the genomic test suggest millions of women could safely avoid chemotherapy, without increasing the risk of their cancer returning.
The international trial followed patients with newly diagnosed breast cancer in the UK, Norway, Australia, New Zealand, Thailand and Sweden, finding that those who received a low score on the test could safely be treated with hormone therapy alone. The randomised study involved 4,429 patients aged 40 or above who had recently been diagnosed with hormone-positive breast cancer, the most common form, accounting for 80% of the breast cancer cases globally.
Participants were assigned to one of two treatment groups. In the standard treatment group, patients received chemotherapy followed by hormone therapy. In the second group, patients had their tumours analysed with the genomic test. The trial compared outcomes between the two groups to determine whether the genomic testing could effectively guide decisions about who truly benefits from chemotherapy.
What is the genome test?
The genome test is a Prosigna test made by the global diagnostics company Veracyte. The test is a genomic assay which analyses 50 genes, predicting an individual’s risk of recurrence (ROR), estimating the likelihood of the cancer progressing, as well as helping oncologists determine if a patient will truly benefit from chemotherapy or if they can safely remain on hormone therapy alone.
How does the test work?
Rather than requiring international shipments of the samples, the test can be performed on preserved tissue from the patient’s original biopsy or surgery right in the local hospital. The test combines the tumour genomic profile with clinical features to generate an ROR score between 0 and 100; the lower the score, the lower the risk of recurrence over ten years, indicating chemotherapy may not be necessary, whereas if the score is higher than chemotherapy is beneficial.
How well does the test perform?
5 years after treatment, 95% of those who had chemotherapy and hormone therapy were alive and free from breast cancer recurrence, whilst 94% of those who skipped chemotherapy, as determined to do so by the Prosigna test, were alive and recurrence-free.
How accurate is the test in the real world and clinical settings?
In a real-world setting, the Prosigna assay has demonstrated strong reliability in identifying patients at low risk of recurrence, particularly for those who are node-negative or have one to three positive lymph nodes. This level of risk prediction can help clinicians determine whether a patient may safely forgo adjuvant chemotherapy.
Validation Data
Evidence from the Danish Breast Cancer Cooperative Group (DBGCC) further consolidates this. In their nationwide cohort of 2,558 postmenopausal women with hormone receptor-positive early breast cancer treated with endocrine therapy alone for five years, the Prosignia Risk of Recurrence score provided a more accurate estimation of 10-year distant recurrence compared with other commercially available genomic panels.
Oncology trials such as this one are a significant step toward more personalised treatment, which understands the needs of an individual rather than a cohort.
Partner with Simbec-Orion for your next Oncology clinical trial.
Advancing breakthroughs in oncology is dependent on meticulous, expertly delivered clinical research and partnering with an organisation experienced in the complexities of cancer trials is essential.
Simbec-Orion’s oncology team brings decades of specialised expertise across solid tumours and haematological malignancies, with a proven track record in managing early-phase to late-phase studies. Our integrated approach, spanning biomarker-driven design, precision medicine methodologies and global operational capability, ensures innovative therapies are evaluated with scientific integrity and operational excellence.For sponsors, developing the next generation of targeted treatments or genomic- guided diagnostics, running a clinical trial with Simbec-Orion provides robust infrastructure, specialist insight and patient-centric focus needed to bring meaningful oncology innovations to the patients who need them most. Speak to our oncology experts today and take the next step toward launching your clinical trial.