Phase 2 Trial of Alisertib Combined with Endocrine Therapy for HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer

What this Trial Is About

Researchers are studying alisertib combined with endocrine therapy in people with hormone receptor-positive, HER2-negative metastatic breast cancer that has recurred or spread after at least two previous endocrine treatments. This Phase 2 study aims to find the best dose of alisertib when given with selected endocrine therapies and to evaluate its effectiveness, safety, and how the body processes the drug. The trial also seeks to identify specific patient groups who may benefit more from this combination. Participants will be randomly assigned to receive one of three different doses of alisertib 50 mg, 40 mg, or 30 mg taken orally twice daily on specific days within each 28-day cycle, along with investigator-chosen endocrine therapy following approved dosing schedules. Endocrine therapy options include oral tablets such as anastrozole, letrozole, exemestane, tamoxifen, or intramuscular fulvestrant injections given on certain days in each cycle. The study design includes parallel groups and dose optimization to assess the combination treatment. During the trial, participants will undergo regular assessments to monitor treatment response, disease control, progression, survival, and any side effects. These include clinical evaluations, laboratory tests, and safety monitoring from the first dose until 28 days after the last dose, with follow-up up to 48 months. Researchers will measure outcomes like objective response rate, duration of response, disease control, progression-free survival, overall survival, and adverse events. The total study duration extends to June 2029.

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