Study on Alisertib with Hormone Therapy for HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer
Sponsor: Puma Biotechnology, Inc.
ClinicalTrials ID:NCT06369285
This clinical trial is testing a new treatment combination of alisertib and hormone therapy for patients with HR-positive, HER2-negative breast cancer that has returned or spread after previous treatments.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to find the best dose of alisertib when used with hormone therapy in patients with HR-positive, HER2-negative breast cancer that has come back or spread after at least two previous hormone treatments. The study will also look at how well this combination works, its safety, and how the body processes the drugs. Researchers aim to identify which patients might benefit the most from this treatment.
Eligibility Criteria
Inclusion Criteria
- Be 18 years or older.
- Have a confirmed diagnosis of breast cancer that has returned or spread and cannot be cured.
- The cancer must have worsened after at least two previous hormone treatments for recurrent or metastatic cancer.
- Must have previously received a CDK4/6 inhibitor with hormone therapy for recurrent or metastatic cancer.
- The cancer must be HR-positive and HER2-negative, as confirmed by local lab tests following specific guidelines.
Exclusion Criteria
- Have received chemotherapy for recurrent or metastatic cancer.
- Have previously been treated with drugs targeting Aurora Kinase A, including alisertib.
Note: There are more criteria to determine eligibility. The study center will assess if you meet all the requirements.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Alabama Oncology | 34235 | Birmingham | Alabama |
| Mayo Clinic Hospital | 85054 | Phoenix | Arizona |
| City of Hope at Orange County Lennar Foundation Cancer Center | 92618 | Irvine | California |
| LA Cancer Network | 90017 | Los Angeles | California |
| UCLA Department of Medicine - Hematology/Oncology | 90095 | Los Angeles | California |
| University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center | 94158 | San Francisco | California |
| University of Colorado School of Medicine | 80045 | Aurora | Colorado |
| Yale University, Yale Cancer Center | 06520 | New Haven | Connecticut |
| Mayo Clinic Florida | 32224 | Jacksonville | Florida |
| Cancer Specialists of North Florida | 32256 | Jacksonville | Florida |
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