UMA-ALI-1201: A PHASE 2 STUDY OF ALISERTIB IN COMBINATION WITH ENDOCRINE THERAPY IN PATIENTS WITH HR+, HER2-NEGATIVE RECURRENT OR METASTATIC BREAST CANCER
The purpose of this research is to see if the investigational study drug, called alisertib, in combination with an 'endocrine therapy' such as anastrozole, letrozole, exemestane, tamoxifen or fulvestrant can help people with HR+, HER2-negative recurrent or metastatic breast cancer.
Age & Gender
- 18 years ~ 99 years
- Male, Female, Gender Inclusive
Visit Availability
- Standard business hours (M-F, 8-5)
Location
What will be asked of you
You will have tests, exams and procedures that are part of your standard care and for study purposes. These will include clinic visits, lab draws, pregnancy testing if applicable, ECGs, scans, biopsy, and receipt of study medications. While you are taking part in this study, you will come to the site at the beginning of each cycle for assessments and treatment. During the first cycle, there will be additional visits for blood sample collection.
Up to 26 months
Looking for Specific Volunteers
Able to participate:
- You have been diagnosed with HR+ HER2 - breast cancer that has either recurred following treatment or metastasized
- Willing to provide tumor tissue for biomarker assessment, either from a new biopsy or from a biopsy at the most recent time of progression of
- You have received at least two prior lines of endocrine therapy for your breast cancer in the recurrent or metastatic setting
Not eligible if:
- You have received treatment with chemotherapy in the recurrent or metastatic setting for your breast cancer.
- You have an active infection that requires treatment within 7 days of entering the study. Patients with bone only disease presenting with only blastic bone
- You have had major surgery within 28 days before entering the study.
- You have central nervous system (CNS) metastases that are either untreated or symptomatic.
- You are unable or unwilling to swallow tablets whole.
Contact the Team
Visit Location
Contact & Visit Location
Primary Contact
- Lineberger Clinical Research
- cancerclinicaltrials@med.unc.edu
- (919) 966-4432
Primary Visit Location
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA
Additional Study Information
Principal Investigator
Claire Dees
LCCC - Clinical Trials
Study Type
Clinical or Medical
Interventional
Study Topics
Cancer (Breast)
IRB Number
24-1654
