With more than 2.3 million new cases in 2023, and close to 700,000 deaths, breast cancer is the second most common cancer worldwide.1,2 PIK3CA mutations are key oncogenic drivers in 35 - 40% of HR-positive and HER2-negative breast cancer.1,2 Identifying PIK3CA mutations accurately and timely is crucial for breast cancer patients, since it makes them eligible for treatment with PI3K inhibitors and consequently can improve outcomes.
HR-positive/HER2-negative advanced or metastatic breast cancer patients with PIK3CA mutations are less likely to benefit from chemotherapy treatment and have a poor overall prognosis.4 More importantly, they are less likely to benefit from standard of care endocrine therapy.5,6,7Therefore, detection of these biomarkers can help ensure patients are correctly diagnosed and can receive the best treatment possible.
Tackling the most common cancer among women requires a less-than-common approach. Our comprehensive portfolio of breast cancer diagnostic solutions builds on Roche’s 40 years of research and innovation in the space. The solution for precise, personalized treatment has never been so clear.
To help metastatic breast cancer patients receive the most effective treatment strategies, clinical laboratories need to be equipped with diagnostic solutions that can accurately detect a multitude of actionable PIK3CA mutations for identification of breast cancer genetic biomarkers. These comprehensive diagnostic tests, including next-generation sequencing and PCR, need to be able to assess and report the status of all required biomarkers, including ER, PR, HER2, Ki67 but also molecular alterations including PIK3CA mutations. These diagnostic tests should also be part of an integrated and standardized workflow in order to maximize accuracy and reproducibility, and to ensure confidence for clinicians in charge of therapy decisions.
Detection of PIK3CA mutations can help determine if a patient with advanced or metastatic breast cancer is eligible to receive PI3K targeted therapy. It has been previously shown that treatment with a PI3K inhibitor can significantly increase survival in patients with PIK3CA-mutated advanced breast cancer.8 Early identification of PIK3CA mutations can help ensure that breast cancer patients receive the personalized treatments they need.
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