October is Breast Cancer Awareness Month, a time to honor the patients and their families worldwide whose lives have been impacted by breast cancer and to recognize the progress being made to combat this pervasive disease.
Globally, breast cancer remains the most common cancer among women, with over 2.3 million new cases reported in 2022.1 In 2025, in the United States alone, an estimated 316,950 women and 2,800 men will be diagnosed2 with invasive breast cancer. Among these patients, about 70%3 – more than 225,000 – will be diagnosed with hormone receptor-positive (HR+) breast cancer. Given these alarming statistics, the need for innovative approaches to fighting breast cancer has never been more pressing.
Genomic Testing
Genomic Testing: Unlocking the Power of Truly Personalized Breast Cancer Treatment
Historically, endocrine therapy and chemotherapy have been the standard of care for HR+breast cancer. However, one of the most transformative advances of the past two decades has been the rise of genomic testing – including the Prosigna® Breast Cancer Assay. These tests can identify patients who may benefit from more intensive therapy or safely avoid chemotherapy – and its long-term toxicities – while still helping patients remain cancer-free. Data strongly support their use in postmenopausal, low-risk, node-negative patients, but evidence has been less definitive for premenopausal women and high-risk postmenopausal patients, particularly when predicting chemotherapy benefit.
To address this challenge, the National Institute for Health and Care Research and the University College London in the United Kingdom (UK) have sought to answer the question of whether these high-risk patients can safely avoid chemotherapy through a series of prospective trials called OPTIMA:4 Optimal Personalised Treatment of Early Breast Cancer Using Multi-parameter Analysis.
Evidence in Action
What We’re Learning from the OPTIMA Trials
OPTIMA Prelim Trial: Prosigna Selected for Best Value of Information
In 2014, a preliminary trial tested the feasibility of enrolling patients in a randomized prospective study to evaluate whether a biomarker could guide more accurate use of chemotherapy in high-risk patients. Multiple risk stratification tests were run on these patient samples, and the results were subjected to a “Value of Information” analysis to determine which test to evaluate in a larger, prospective trial. The Prosigna test was ultimately selected as the enrollment test for the OPTIMA main trial, a 4,500 patient, prospective study.
In May 2025, the long-term outcomes of this study were presented5 at the ESMO Breast Cancer Congress,6 with the following key findings:
- The Prosigna test demonstrated higher prognostic accuracy in high-risk patients (node-positive and high-risk node-negative) compared to the test originally used to assign treatment groups.
- Among the patients with low recurrence scores (≤ 25), 22% had discordantly high Prosigna scores (≥ 60). This group had the worst 10-year recurrence free interval (RFI) at 74% (95% Confidence Interval [CI] 62-83%), significantly worse than the concordantly low-risk group (RFI 89%, 95% CI 84-92%; Hazard Ratio [HR] 2.32, 95% CI 1.26-4.24, p = 0.0067; adjusted HR 1.97, 95% CI 1.01-1.97).
- These results confirm the superior prognostic performance of the Prosigna test, in line with previous retrospective studies.
OPTIMA Main Trial: Moving from Assumptions to Answers
OPTIMA main is a prospective, randomized, blinded, Phase 3 trial. The trial is evaluating whether outcomes are similar when patients identified as having low-risk disease by a genomic test – the Prosigna test – are treated with hormonal therapy alone versus the combination of hormonal therapy with chemotherapy.
Since 2017, the OPTIMA main trial has enrolled more than 4,400 patients across the UK, Norway, Australia, New Zealand, and Thailand to compare standard of care endocrine therapy and chemotherapy to therapy guided by the Prosigna test. Enrollment was completed in the UK in late 2024 and in Norway in August 2025 and is set to wrap up in the remaining countries by the end of 2025. The primary analysis of the results, expected in 2026, aim to deliver the definitive answer on whether the Prosigna test can predict which clinically high-risk patients benefit from chemotherapy, and which can safely forego it.
OPTIMA-Young Trial: Empowering Confident Decisions for Premenopausal Women
OPTIMA-Young is a global trial focused entirely on premenopausal women, spanning 15 countries across Europe, Oceania, and Latin America with a target enrollment of 3,380 patients. Running in tandem with the OPTIMA main trial, OPTIMA-Young will contribute to a combined analysis encompassing data from 5,000 premenopausal participants across both studies. Mirroring the OPTIMA main trial design, it uses the Prosigna Breast Cancer Assay to guide treatment decisions and will strengthen the data in premenopausal women.
The Prosigna Test: The Test To Answer More Than One Question
The Prosigna Breast Cancer Assay is an advanced genomic test for patients with invasive, early-stage HR+ breast cancer that helps guide more personalized treatment decisions. It is the only assay validated using the four intrinsic molecular subtypes – Luminal A, Luminal B, HER2-enriched, and Basal-like.
The Prosigna test uniquely integrates this subtype information with a proliferation score and key clinicopathologic factors to generate a single 10-year Risk of Recurrence (ROR) score. This insight into the likelihood of cancer returning empowers physicians and patients to make more precise, personalized treatment decisions to help lead to better outcomes.
Looking Ahead
Advancing the Future of Breast Cancer Care Together
Breast Cancer Awareness Month offers us all a moment to take stock of how far we’ve come, and how much further we have yet to go. Standard treatments like endocrine therapy and chemotherapy have saved countless lives, but advances in genomic testing, like the Prosigna Breast Cancer Assay, and discoveries made in large-scale studies such as the OPTIMA trials, are opening the door to truly personalized care in breast cancer.
By combining awareness with continued research and innovation, we move closer to a future where physicians have the data they need to confidently guide treatment decisions – ensuring every patient receives the right therapy at the right time, with the best chance for long-term health. Veracyte stands alongside physicians, patients, and the broader community as an ally to not only raise awareness, but to also recognize the progress transforming breast cancer care for patients everywhere.
Talk to your doctor about whether the Prosigna test is right for you.
If you have questions or need more information about the Prosigna test, we’re here to help. Connect with a member of our team at [email protected].