"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. "These new therapeutics have not yet been evaluated in a dedicated large, randomized trial as a potential treatment for the 30-40 percent of women with HR-positive, HER2-negative advanced breast cancer who are pre- or perimenopausal".
The MONALEESA-7 trial met its primary endpoint of progression-free survival in premenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative advanced breast cancer. "It is also the first trial to show that ribociclib can be safely and effectively combined with either tamoxifen or a nonsteroidal aromatase inhibitor together with ovarian suppression using goserelin". In a recent phase 2, Simon 2-stage trial, researchers found that the drug, abemaciclib, a selective CDK4/6 inhibitor, was effective in eliciting a partial treatment response in HR+/HER2- patients. The overall response rate was 51 percent for ribociclib versus 36 percent for placebo, and clinical benefit rate was 80 versus 67 percent in patients with measurable disease at baseline.
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As expected, the most frequent adverse event was neutropenia, which was reported in 76 percent of patients in the ribociclib arm compared with 8 percent in the placebo arm. All tumours in the study cohort were centrally assessed for HER2 positivity, PD-1 ligand (PD-L1) status, and quantity of tumour-infiltrating lymphocytes (TILs).
"Longer follow-up is needed to determine whether the trial will meet its secondary end point of overall survival", Tripathy said in a statement.
More severe global warming predictions are likely more accurate
The latest research suggests the models that most accurately predict today's climate patterns are the ones that predict less cloud cooling in the future.
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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