University of Wisconsin, Madison
The goal of this clinical trial is to learn if alisertib in addition to usual care works to treat HR+/HER2+ breast cancer. The main questions it aims to answer are: * Does alisertib stop the communication between HR and HER2? * Are there genetic markers that predict how well someone's cancer will respond to alisertib? Participants will receive alisertib in addition to their usual care.
This pilot clinical trial will evaluate alisertib in combination with standard of care endocrine therapy and Human Epidermal Growth Factor Receptor-2 (HER2)-targeted therapy in participants with Stage IV hormone receptor positive (HR+)/ HER2 positive (HER2+) breast cancer, utilizing our novel 3-gene biomarker signature for patient selection and response prediction
Inclusion Criteria: * Age \> 18 years at the time of consent. * ECOG performance status \</=2 (Karnofsky \>/=60%). * Metastatic HR+/HER2+ breast cancer (estrogen receptor (ER) and/or progesterone receptor (PR) ≥1%, HER2 3+ by immunohistochemistry (IHC) or amplified by in situ hybridization (ISH). * Prior standard induction treatment with chemotherapy + trastuzumab + pertuzumab (HP) or fam-trastuzumab deruxtecan (T-DXd) and have completed a minimum of 4 cycles without progressive disease. * Planned to start or are receiving endocrine therapy + HER2-directed (HP or pertuzumab/trastuzumab/hyalur…
Alisertib 40mg on days 1-7 of 21-day cycles for 4 cycles
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