A Phase 2 Study of Alisertib in Combination With Endocrine Therapy in Patients With HR+, HER2-negative Recurrent or Metastatic Breast Cancer

Primary

• Objective Response Rate (ORR) Within Dose Subgroup

  Objective response rate is defined as the percentage of participants demonstrating a confirmed objective response during the study.

  Time frame: From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months

• Duration of Response (DOR) Within Dose Subgroup

  Duration of response is measured from the time at which measurement criteria are first met for Complete Response (CR) or Partial Response (PR) (whichever status is recorded first) until the first date of recurrence or progressive disease (PD) or death is objectively documented.

  Time frame: From start date of response (after date of randomization) to first PD, assessed up to 48 months

• Disease Control Rate (DCR) Within Dose Subgroup

  Disease control rate is the proportion of participants who achieve overall tumor response (confirmed CR or PR) or Stable Disease (SD) lasting for at least 24 weeks from randomization.

  Time frame: From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months

• Progression Free Survival (PFS) Within Dose Subgroup

  Progression Free Survival (PFS) is measured in months and based on the local tumor assessment. The time interval from the date of randomization until the first date on which recurrence, progression, or death due to any cause, is documented.

  Time frame: From date of randomization to date of recurrence, progression or death, assessed up to 48 months

• Overall Survival (OS) Within Dose Subgroup

  Overall survival (OS) is defined as the time from randomization to death due to any cause, censored at the last date known alive on or prior to the data cutoff employed for the analysis, whichever was earlier.

  Time frame: From date of randomization to death, assessed up to 48 months

• Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) in the Enrolled Population

  Treatment emergent adverse events are those events reported on or after the first dose of investigational product and up to 28 days after last dose.

  Time frame: From date of first dose through last dose plus 28 days, assessed up to 48 months