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Trastuzumab Does Not Benefit HER2-Low Breast Cancer Patients

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"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.

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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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