NCT06369285Phase 2Recruiting

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

Study sponsor: Puma Biotechnology, Inc. · PBYI

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2027-12-30Estimated

Enrollment · participants225Estimated

Source updated2026-07-27Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-07-27 · 2 fields changed

Planned enrollment increased by 75 participants

− Before

~~150 participants (planned)~~

+ After

225 participants (planned)

Primary completion date changed

− Before

~~30 Jun 2027~~

+ After

30 Dec 2027

Check registry source

Study details

Conditions studied

Hormone Receptor Positive HER-2 Negative Breast Cancer; Metastatic Breast Cancer; Recurrent Breast Cancer

Treatments or interventions studied

AlisertibDrugAlso known as PB-8237, MLN8237
Endocrine therapyDrug

Primary outcomes · main study measures

Read the study measures

measure: Objective Response Rate (ORR) Within Dose Subgroup; description: Objective response rate is defined as the percentage of participants demonstrating a confirmed objective response during the study.; timeFrame: From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months; measure: Duration of Response (DOR) Within Dose Subgroup; description: 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.; timeFrame: From start date of response (after date of randomization) to first PD, assessed up to 48 months; measure: Disease Control Rate (DCR) Within Dose Subgroup; description: 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.; timeFrame: From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months; measure: Progression Free Survival (PFS) Within Dose Subgroup; description: 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.; timeFrame: From date of randomization to date of recurrence, progression or death, assessed up to 48 months; measure: Overall Survival (OS) Within Dose Subgroup; description: 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.; timeFrame: From date of randomization to death, assessed up to 48 months; measure: Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) in the Enrolled Population; description: 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.; timeFrame: From date of first dose through last dose plus 28 days, assessed up to 48 months

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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