Phase IB/II Study of Bazedoxifene in Combination with Palbociclib in Patients with Endocrine Resistant Hormone Receptor-Positive Breast Cancer

In this phase Ib/II clinical trial, the investigators evaluated the efficacy and safety of the combination of palbociclib with bazedoxifene in patients with a metastatic endocrine-resistant hormone receptor-positive, HER2-negative breast cancer. Furthermore, whole exome sequencing of cell-free tumor DNA was done on serial samples from these patients, revealing potential molecular changes associated with mechanisms of resistance. ]]>
We enrolled female or male patients, aged 18 years or older, with histologically confirmed invasive breast cancer that was metastatic or unresectable locally advanced disease. The tumors were hormone receptor positive, HER2-negative. Progressive disease on prior endocrine treatment was required. Prior therapy with up to two lines of chemotherapy was allowed. There was no limit to the number of prior endocrine therapies.]]>