SAR439859 is a potent, orally bioavailable, and selective estrogen receptor (ER) inhibitor that belongs to the selective estrogen receptor degrader (SERD) class of compounds. Sanofi's SAR439859 has been selected as the oral SERD for this study. The EOP study will use an oral SERD as the endocrine therapy backbone. Next-generation orally-bioavailable SERDs with improved pharmacokinetic properties are promising potential therapies for HR+ breast cancer.
The selective estrogen receptor degrader (SERD) class of compounds have demonstrated benefit in HR+ HER2-negative metastatic breast cancer, including tumors with estrogen receptor activating mutations.
#A pilot study eyespy trial
The EOP is a sub-study within the main I-SPY-2 clinical trial utilizing an endocrine therapy backbone for patients whose tumors are predicted to be sensitive to endocrine therapy but for whom chemotherapy provides little or no benefit. However, these patients often have late risk of recurrence (after 5 years), and thus also need novel strategies that are more tolerable and more effective than the current standard. These patients historically have been excluded from the I-SPY2 trial due to the predicted lack of chemotherapy benefit. This study arm, known as the I-SPY-2 Endocrine Optimization Pilot Protocol (EOP), is focused on patients with molecularly low risk (MammaPrint low risk signature), clinically high risk, hormone receptor positive (HR+), and HER2-negative breast cancer. SAN FRANCISCO, J/PRNewswire/ - Quantum Leap Healthcare Collaborative™ (Quantum Leap) announced today an evaluation of SAR439859, an oral estrogen receptor degrader (SERD) in a new I-SPY 2 study arm targeting patients with newly diagnosed hormone receptor-positive (HR+) clinical stage 2/3 invasive breast cancer.
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