Alisertib with Endocrine Therapy for HR-positive, HER2-negative Metastatic Breast Cancer
This study is testing a new combination of medicines, alisertib and endocrine therapy, for people with hormone receptor-positive (HR-positive), HER2-negative metastatic or recurrent breast cancer. This is for patients whose cancer has progressed after at least two previous endocrine therapies. Alisertib is taken by mouth on specific days, along with your doctor's chosen endocrine therapy (like anastrozole or letrozole). The main goals are to see how many people respond to the treatment (Objective Response Rate), how long that response lasts (Duration of Response), and how many people have their disease controlled (Disease Control Rate). The study aims to find the best dose of alisertib and understand its effects. We don't know the current recruitment status.
- Study design
- This is a randomized, dose optimization, multicenter Phase 2 study. It plans to enroll 225 participants.
- What's involved
- Alisertib enteric-coated tablets will be taken by mouth twice daily on days 1-3, 8-10, and 15-17 of each 28-day cycle. Endocrine therapy will be taken daily in 28-day cycles.
- Compensation
- Not stated in the trial record.
- Follow-up
- Responses and disease control will be assessed for up to 48 months (4 years).
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A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer
At a glance
Conditions
Where it's being run
53 sites across 21 statesStudy leadership
- Chief Reg Affairs, PV, Medical Affairs and Law Officer · STUDY_DIRECTOR · Puma Biotechnology, Inc.
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Objective Response Rate (ORR) Within Dose SubgroupFrom date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
Objective response rate is defined as the percentage of participants demonstrating a confirmed objective response during the study.
- Duration of Response (DOR) Within Dose SubgroupFrom start date of response (after date of randomization) to first PD, assessed up to 48 months
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.
- Disease Control Rate (DCR) Within Dose SubgroupFrom date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
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.
- Progression Free Survival (PFS) Within Dose SubgroupFrom date of randomization to date of recurrence, progression or death, assessed up to 48 months
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.
- Overall Survival (OS) Within Dose SubgroupFrom date of randomization to death, assessed up to 48 months
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.
- Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) in the Enrolled PopulationFrom date of first dose through last dose plus 28 days, assessed up to 48 months
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.