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Anti-mitotic agent

Alisertib 50 mg for Breast Cancer (ALISCA-Breast1 Trial)

Phase 2

Waitlist Available

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

ALISCA-Breast1 Trial 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.Check my eligibility

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.See study design

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.

ALISCA-Breast1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomization to death, assessed up to 48 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Disease Control Rate (DCR) Within Dose Subgroup

Duration of Response (DOR) Within Dose Subgroup

Objective Response Rate (ORR) Within Dose Subgroup

+3 more

Secondary outcome measures

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

ALISCA-Breast1 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

Endocrine therapy

2019

Completed Phase 3

~35530

Alisertib

2010

Completed Phase 2

~1140

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Puma Biotechnology, Inc.Lead Sponsor

57 Previous Clinical Trials

9,792 Total Patients Enrolled

14 Trials studying Breast Cancer

4,397 Patients Enrolled for Breast Cancer

Chief Scientific OfficerStudy DirectorPuma Biotechnology, Inc.

8 Previous Clinical Trials

1,462 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary aim of conducting this clinical investigation?

"As per the sponsor, Puma Biotechnology, Inc., this trial's primary outcome is Objective Response Rate (ORR) Within Dose Subgroup. This measure will be tracked from response initiation post-randomization to initial progression or up to a 48-month period. Secondary outcomes include Duration of Response (DOR) Within Biomarker-Defined Subgroup - calculated from first CR/PR fulfillment till recurrence/PD/death documentation; Progression Free Survival (PFS) Within Biomarker-Defined Subgroup - duration between randomization and first documented PD/recurrence/death; and Overall Survival (OS) Within Biomarker-Defined Sub"

Answered by AI

Is the enrollment for this medical study currently open?

"As per data from clinicaltrials.gov, recruitment for this trial is closed. The initial posting date was 31st December 2024 with the latest update on 12th April 2024. Despite this study no longer accepting applicants, there are currently 3440 other trials actively enrolling participants."

Answered by AI

Has the FDA given its approval for Alisertib at a dosage of 50 mg?

"In this Phase 2 trial, Alisertib at a dose of 50 mg received a safety rating of 2 from our team at Power. This suggests that while there is some existing data on its safety profile, evidence regarding its effectiveness is currently lacking."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06369285.