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Anti-mitotic agent

Alisertib + Endocrine Therapy for Breast Cancer (ALISCA-Breast1 Trial)

Phase 2
Recruiting
Research Sponsored by Puma Biotechnology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization to death, assessed up to 48 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a drug called alisertib in combination with endocrine therapy for patients with a specific type of breast cancer that has spread. The study aims to find the best dose of al

Who is the study for?
This trial is for individuals with HR-positive/HER2-negative metastatic breast cancer who have already tried at least two endocrine therapy lines without success. Participants must have confirmed pathology reports and can't join if they've had certain treatments or conditions that the study details exclude.
What is being tested?
The PUMA-ALI-1201 study tests different doses of Alisertib combined with standard endocrine therapy to find the best dose and assess its effectiveness, safety, and how it's processed in the body. It also aims to identify specific patient subgroups most likely to benefit from this combination treatment.
What are the potential side effects?
While not specified here, common side effects of Alisertib may include blood cell count changes, fatigue, nausea, diarrhea, hair loss, and possible allergic reactions. Endocrine therapies often cause hot flashes, mood swings, bone density loss among others.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization to death, assessed up to 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization to death, assessed up to 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease Control Rate (DCR) Within Dose Subgroup
Duration of Response (DOR) Within Dose Subgroup
Objective Response Rate (ORR) Within Dose Subgroup
+3 more
Secondary study objectives
Disease Control Rate (DCR) Within Biomarker-Defined Subgroup
Duration of Response (DOR) Within Biomarker-Defined Subgroup
Objective Response Rate (ORR) Within Biomarker-Defined Subgroup
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Alisertib 50 mgExperimental Treatment2 Interventions
Alisertib with selected endocrine therapy
Group II: Alisertib 40 mgExperimental Treatment2 Interventions
Alisertib with selected endocrine therapy
Group III: Alisertib 30 mgExperimental Treatment2 Interventions
Alisertib with selected endocrine therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alisertib
2010
Completed Phase 2
~1260
Endocrine therapy
2019
Completed Phase 3
~35530

Find a Location

Who is running the clinical trial?

Puma Biotechnology, Inc.Lead Sponsor
57 Previous Clinical Trials
9,942 Total Patients Enrolled
14 Trials studying Breast Cancer
4,351 Patients Enrolled for Breast Cancer
Chief Reg Affairs, PV, Medical Affairs and Law OfficerStudy DirectorPuma Biotechnology, Inc.
Chief Scientific OfficerStudy DirectorPuma Biotechnology, Inc.
10 Previous Clinical Trials
2,536 Total Patients Enrolled
~100 spots leftby Jun 2027
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