Clinical Trial 23340

• Overview

  Study Title:

  A Phase 2 study of alisertib in combination with endocrine therapy in patients with HR+, HER2-negative recurrent or metastatic breast cancer

  Objective:

  Primary objective: Determine the optimal alisertib dose level administered in combination with selected endocrine therapy to be used in future studies based on safety and efficacy. Secondary objectives: Determine whether any biomarkers correlate with efficacy Evaluate the pharmacokinetic (PK) analysis profile of alisertib

• Treatments

  Therapies:

  Aurora Kinase Inhibitor; Endocrine therapy

  Medications:

  Alisertib (MLN8237); Anastrozole (); Arimadex (Anastrozole); Aromasin (Exemestane); Exemestane (); Faslodex (fulvestrant); Femara (Letrozole); Letrozole (); Tamoxifen (); fulvestrant ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Aged ≥18 years at signing of informed consent.
  • Pathology-confirmed diagnosis of adenocarcinoma of the breast with evidence of recurrent or metastatic disease not amenable to curative therapy.
  • Progression on or after treatment with at least two prior lines of endocrine therapy in the recurrent or metastatic setting. a. 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.
  • Participants must have received a CDK4/6i in combination with endocrine therapy in the recurrent or metastatic setting.
  • 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.

• Exclusion Criteria

  Key Exclusion Criteria:
  • Treatment with chemotherapy in the recurrent or metastatic setting.
  • Prior treatment with an Aurora Kinase A (AURKA) specific-targeted or pan-Aurora-targeted agent, including alisertib, in any setting.

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