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PBYIPuma Biotechnology, Inc.Signing up patients

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

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

0Calmworry score, out of 100

No strong warning signs right now. The score counts warning signs; it is not a prediction.

Why this score

No warning signs right now. That's why the score is 0.

Score over time

Stage
Phase 2
Patients
225 (planned)
Started
Nov 19, 2024
Main results expected
Dec 30, 2027
Fully finished
Jun 30, 2029
Results posted
not yet

What counts as success

The trial's main goal(s), called the “primary outcome.”

  • Objective Response Rate (ORR) Within Dose Subgroup

    Measured over: 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 over: 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 over: 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 over: From date of randomization to date of recurrence, progression or death, assessed up to 48 months

  • Overall Survival (OS) Within Dose Subgroup

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

Changes Tremor has spotted

No changes since Tremor started watching this trial.
Show details (technical version)

Score inputs

  • none

Raw record changes

  • none yet

Trial ID NCT06369285 · record last updated 2026-10-01 · checked 2026-11-09 15:36 UTC

See the official record on ClinicalTrials.gov (NCT06369285) ↗