A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer

Required: ESR1 positive

HR-positive and HER2-negative tumor status reported per local laboratory testing. HR and HER2 testing must be performed consistent with current American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) or European Society of Medical Oncology (ESMO) guidelines

Required: HER2 (ERBB2) negative

HR-positive and HER2-negative tumor status reported per local laboratory testing. HR and HER2 testing must be performed consistent with current American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) or European Society of Medical Oncology (ESMO) guidelines

Must have received: endocrine therapy — recurrent or metastatic

Progression on or after treatment with at least two prior lines of endocrine therapy in the recurrent or metastatic setting. If metastatic disease recurrence occurs during or within six months of discontinuing adjuvant endocrine therapy, then that endocrine therapy will count as one line of prior therapy.

Must have received: CDK4/6 inhibitor — recurrent or metastatic

Participants must have received a CDK4/6i in combination with endocrine therapy in the recurrent or metastatic setting.

Cannot have received: chemotherapy

Treatment with chemotherapy in the recurrent or metastatic setting.

Cannot have received: Aurora Kinase A inhibitor (alisertib)

Prior treatment with an Aurora Kinase A (AURKA) specific-targeted or pan-Aurora-targeted agent, including alisertib, in any setting.