Hormone Receptor Positive HER-2 Negative Breast Cancer study: Alisertib vs Endocrine therapy
Official title A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT06369285
What this study is testing
What is Alisertib?
Alisertib is an investigational oral medication being studied for hormone receptor positive HER‑2 negative metastatic breast cancer.
Also referred to as PB‑8237, MLN8237.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find the best dose of alisertib when used with endocrine therapy and to see how well it works, how safe it is, and how it behaves in the body. It also looks for specific biomarkers that might predict who benefits most.
- Who it's for
- Women with confirmed hormone‑positive, HER2‑negative breast cancer that has spread or come back after at least two previous endocrine treatments.
- What's involved
- Participants will receive alisertib plus an endocrine drug, attend regular clinic visits, and undergo blood tests and imaging to monitor the drug’s effects and safety.
- Time commitment
- The study lasts several months, with scheduled visits every few weeks for medication, tests, and follow‑up assessments.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Aged ≥18 years at signing of informed consent.
- Pathology-confirmed diagnosis of breast cancer 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.
- 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.
You likely can't join if
- Treatment with chemotherapy in the recurrent or metastatic setting, including antibody drug conjugates with a chemotherapeutic payload.
- Prior treatment with an Aurora Kinase A (AURKA) specific-targeted or pan-Aurora-targeted agent, including alisertib, in any setting.
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Beverly Hills, California, United States
- Fountain Valley, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Jacksonville, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- Columbia, Missouri, United States
- Kansas City, Missouri, United States
- Springfield, Missouri, United States
- St Louis, Missouri, United States
- Reno, Nevada, United States
+ 24 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Phoenix, Arizona, United States; Beverly Hills, California, United States; Fountain Valley, California, United States; Irvine, California, United States; Los Angeles, California, United States and 38 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.