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A randomized, double-blind, phase 2 study of ruxolitinib or placebo in combination with capecitabine in patients with advanced HER2-negative breast cancer and elevated C-reactive protein, a marker of systemic inflammation

Breast Cancer Research and Treatment Jul 03, 2018

O’Shaughnessy J, et al. - Researchers investigated if the addition of ruxolitinib (a Janus-associated kinase [JAK]1/JAK2 inhibitor) to capecitabine would be a safe and effective treatment option in patients with HER2-negative advanced breast cancer and high systemic inflammation (modified Glasgow Prognostic Score [mGPS] ≥ 1). They assessed overall survival (OS) following the treatment regimen of 21-day cycles of ruxolitinib or placebo plus capecitabine in patients with ≤ 2 prior chemotherapy regimens for advanced or metastatic disease or hormone receptor-positive patients with disease progression on prior hormonal therapies. General tolerability of ruxolitinib plus capecitabine for patients with advanced breast cancer and high systemic inflammation was demonstrated by findings; overall response rate (ORR) was numerically greater, and a more favorable change in HRQoL was observed, but no improvement was seen in OS and progression-free survival (PFS) relative to placebo plus capecitabine.

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