"About 15% of breast cancers are HER2-positive, but another 45% have low levels of HER2, and these patients are not now treated with adjuvant trastuzumab", said Louis Fehrenbacher, MD, of the Kaiser Permanente Vallejo Medical Center in California, according to a press release.
"MONALEESA-7 is the first clinical trial to have the statistical power to show that ribociclib has clinical benefit specifically for pre- and perimenopausal women with HR-positive, HER2-negative advanced breast cancer", continued Tripathy.
MONALEESA-7 is a phase III randomized, double-blind, placebo-controlled trial investigating the efficacy and safety of Kisqali in combination with oral hormonal therapies and goserelin versus endocrine treatment alone in premenopausal or perimenopausal women with HR+/HER2- advanced breast cancer who had not previously received endocrine therapy for advanced disease. Neither adapted DFS nor OS differed between the groups in multivariate analyses adjusted for patient and tumor variables and chemotherapy (hazard ratio [HR] for DFS, 0.97; 95% CI: 0.75-1.25; P =.8; HR for OS, 0.98; 95% CI: 0.67-1.42; P =.9).
The Game Awards 2017
According to Keighley, The Game Awards will feature world premiere announcement for two games that gamers have never seen before.
Preliminary estimates of median progression-free survival have reached 10.4 months.
Data are available for some of the secondary endpoints. Grade 3/4 neutropenia was reported in 61 percent of patients in the ribociclib arm compared with 4 percent in the placebo arm, but it was asymptomatic in most patients; neutropenia associated with fever and infection was reported in 2 percent of patients in the ribociclib arm and 1 percent in the placebo arm. Other adverse events included hot flashes, nausea, leukopenia, and joint pain/stiffness.
Results from the PANACEA study, recently presented at the San Antonio Breast Cancer Symposium, have suggested that immunotherapy may help to overcome trastuzumab-resistant breast cancer.
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