A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer
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Sponsored by Puma Biotechnology, Inc. (industry) · PBYI — their whole pipeline →.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
225estimated
Sites
53
Countries
Portugal, Spain, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-11-19 | actual | When the study began enrolling |
| Primary completion | 2027-12-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-06-30 | estimated | The whole study's end, after follow-up |
| First posted | 2024-04-16 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-27 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Hormone Receptor Positive HER-2 Negative Breast Cancer
- Metastatic Breast Cancer
- Recurrent Breast Cancer
Interventions
- Drug: Alisertib — also filed as PB-8237, MLN8237
- Drug: Endocrine therapy
Primary outcomes
what the primary-completion date above is the date OFObjective Response Rate (ORR) Within Dose Subgroup
measured 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
measured From start date of response (after date of randomization) to first PD, assessed up to 48 months
Disease Control Rate (DCR) Within Dose Subgroup
measured 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
measured From date of randomization to date of recurrence, progression or death, assessed up to 48 months
Overall Survival (OS) Within Dose Subgroup
measured 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
measured From date of first dose through last dose plus 28 days, assessed up to 48 months
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