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Studying the Effects of Removing Adjuvant Chemotherapy for the Treatment of Estrogen Receptor-Positive, HER2-Negative Breast Cancer in Patients with a Low-Genomic Risk, SELECT Trial

Trial Status: active

This phase II trial studies whether removing chemotherapy after mastectomy or lumpectomy (adjuvant chemotherapy) affects the length of time treatment is taken (treatment persistence) in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer and a recurrence score (RS) ≤ 25 (low-genomic risk). Adjuvant chemotherapy works in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is given to minimize or prevent the cancer from returning following mastectomy or lumpectomy. Adjuvant chemotherapy is often recommended as part of the “standard treatment regimen”, alongside optimized endocrine therapy (ET), with letrozole or anastrozole, and ribociclib. Letrozole or anastrozole blocks the use of estrogen by the tumor cells. They may also be given with goserelin to block hormone production in the ovaries or testicles. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The benefits of adjuvant chemotherapy in patients with a low-genomic risk are controversial. There is ongoing debate about whether chemotherapy benefit arises primarily from endocrine effects or its direct cytotoxic effects. There is also uncertainty regarding the extent to which adjuvant chemotherapy affects the treatment persistence of ribociclib. Removing adjuvant chemotherapy before treatment with ET and ribociclib in patients with ER-positive, HER2-negative breast cancer and a low-genomic risk may help researchers determine it's effects on ribociclib treatment persistence and improve treatment recommendations.