To evaluate safety and tolerability of tucatinib used in combination with palbociclib and
letrozole, and to confirm that current RP2D of tucatinib and FDA approved dosing of
palbociclib remain the same in the triplet combination
The purpose of this study is to determine whether adding a year of everolimus to standard adjuvant hormonal therapy improves disease-free interval in patients with hormone-receptor-positive and HER2-negative breast cancer.
Eligible adult patients (either sex) have a diagnosis of breast cancer and have completed surgery, radiation therapy, and/or adjuvant or neoadjuvant chemotherapy and have no evidence of disease at time of study entry.
Patients with inflammatory breast cancer or metastatic disease, serious cardiac disease, uncontrolled diabetes, hepatitis, uncontrolled pulmonary disease, or impaired gastrointestinal function are not eligible.
Estimated Enrollment: 3500 patients from multiple cancer centers in the US.
Endocrine therapies are commonly used to treat hormone-related cancers such as breast and prostate cancers. However, resistance to these therapies is a persistent challenge. The objective of this proposal is to understand dynamic changes of ER /AR-bound enhancers during cancer progression. The knowledge gained will increase our ability to assess therapeutic responsiveness in breast and prostate cancers.