The Methodist Hospital Research Institute
The study will investigate if CDK4/6 inhibitor holiday will reset the cell cycle process to respond to the combination of fulvestrant and abemaciclib, and this approach may represent an effective therapeutic strategy to manage such patients.
Endocrine therapy, including aromatase inhibitor therapy, is the primary treatment for ER-positive metastatic disease. Despite the effectiveness of this treatment, not all patients respond to it and many patients who are initially responsive to the drug, eventually develop resistance to it. The management of patients with ER-positive, HER2-negative metastatic breast cancer who experience disease progression after standard treatment (CDK4/6 inhibitor plus an aromatase inhibitor) is a significant challenge and identification of new therapeutic strategies for this population of patients remains a…
Inclusion Criteria: 1. Male or Female \>18 years of age on the day of informed consent signing. 2. Progression on a CDK4/6 inhibitor in combination with an AI immediately prior to the enrollment on this study 3. Histologically confirmed ER-positive, HER2-negative metastatic breast cancer. ER-positive is defined as ≥1% immunohistochemical (IHC) staining of any intensity. HER2 test result is negative if a single test (or both tests) performed show: * IHC 1+ or 0 * In situ hybridization negative based on: * Single-probe average HER2 copy number \<4.0 signals/cell * Dual-probe H…
The study is evaluating if a drug holiday (post CDK inhibitors progression) will reset the cell cycle machinery to be responsive to Abemaciclib and Fulvestrant.
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