Hormone-receptor (HR) positive, HER2-negative breast cancers make up about 60 % of the primary tumors. For these patients with 0 or up to 3 positive lymph nodes, the indication for chemotherapy is based on an accurate risk stratification. In this situation, conventional clinicopathological parameters are often not suitable for selecting those patients who would not benefit from adjuvant chemotherapy. The EndoPredict test combines a molecular signature with clinical risk factors such as tumor size and nodal status and stratifies patients into “low” or “high” risk groups and thereby improves decision-making. The EndoPredict test can predict the 10-year risk of distant metastases in patients with HR+/HER2- primary breast cancer with endocrine treatment (Evidence level I-B).
Patients with HR+/HER2- primary invasive breast cancer stage I/II and T1 to T3 with 0 to 3 positive lymph nodes and an EndoPredict test within six months prior to inclusion are eligible. Primary objective is to show that patients tested as “low risk” by EndoPredict and treated with adjuvant endocrine therapy alone for at least 5 years have a 10-year distant metastasis-free survival of > 90 %. Secondary endpoints include distant metastasis-free survival, disease-free survival and overall survival in patients with EPclin “low” vs “high” risk. Also, the proportion of patients whose treatment was concordant and non-concordant with EndoPredict test results, will be analyzed for survival. The prognostic performance of classical prognostic factors with respect to survival will also be assessed. Patients will be evaluated annually for 10 years regarding treatment compliance, recurrence, metastases, and survival. Start of accrual was in July 2018. At least 35 sites in Germany and one site in Switzerland will be active. Current data on enrollment will be reported. Survival data of patients who have been tested with EndoPredict are systematically assessed to prospectively prove that patients with a low risk classification by EndoPredict can safely forgo chemotherapy and be treated with endocrine therapy alone.
NOGGO-B3 [18.12.2017].
North-Eastern German Society for Gynaecological Oncology e.V. (NOGGO e.V.).
Myriad Service GmbH.
C. Denkert: Patent holder: EP18209672 Patent application; Consulting fees: Fa, Teva, Novarits, Pfizer, Roche, Amgen, MSD, Daiichi, Celgene, AstraZeneca; Ownership interests: Sividon Diagnostics. M. Untch: Consulting fees: Linde. M. Kiechle: Speakers honorarium: Myriad, January 2018. All other authors have declared no conflicts of interest.