Actively Recruiting
Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer
Led by University of Washington · Updated on 2026-04-16
60
Participants Needed
2
Research Sites
201 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
B
Breast Cancer Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial tests the accuracy of functional imaging (FFNP)-positron emission tomography (PET)/computed tomography (CT) to predict response to abemaciclib plus endocrine therapy. Abemaciclib is a drug used to treat certain types of hormone receptor positive (HR+), HER2 negative breast cancer. Abemaciclib blocks certain proteins, which may help keep tumor cells from growing. Endocrine therapy adds, blocks, or removes hormones that can cause cancer to grow. FFNP PET imaging is a form of x-ray that uses FFNP as an imaging agent that may provide more precise information about the location of tumors that "light up" with FFNP than a PET scan alone can provide.
CONDITIONS
Official Title
Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women with metastatic or locally advanced unresectable breast cancer
- Histologically confirmed ER+ / HER2-negative breast cancer suitable for endocrine therapy
- Premenopausal patients must have received GnRH agonist treatment for at least 6 weeks before imaging
- Disease present at one or more non-liver sites, measurable or non-measurable but at least 1.5 cm on imaging
- No limits on prior endocrine therapy lines; one prior chemotherapy line allowed with required washout periods
- ECOG performance status of 0, 1, or 2
- At least 18 years of age
- Absolute neutrophil count of at least 1,500/uL
- Platelet count of at least 100,000/uL
- Hemoglobin level of at least 9 g/dL
- Total bilirubin less than or equal to 1.5 times the upper limit of normal (ULN), or less than 2 times ULN if Gilbert's syndrome
- AST/ALT less than or equal to 2.5 times ULN, or less than or equal to 5 times ULN if liver metastases
- Estimated glomerular filtration rate (eGFR) of 30 mL/min or higher
- Women of childbearing potential agree to use effective contraception during the study
- Ability and willingness to provide informed consent
- Consent to allow access to archival tumor and blood samples for clinical sequencing
You will not qualify if you...
- Prior abemaciclib treatment in metastatic setting or within 2 years of completing adjuvant abemaciclib
- Metastatic disease only in the liver
- History of other cancers unless treated with no disease evidence for at least 2 years
- Currently receiving other investigational treatments
- Untreated or unstable brain metastases; stable treated brain metastases allowed
- History of allergic reaction to FFNP, abemaciclib, or study agents
- Uncontrolled illnesses such as active infections, heart failure, unstable angina, or arrhythmia
- Pregnant or breastfeeding women
- HIV patients with CD4+ counts below 350 cells/mcL or recent AIDS-defining infections without effective therapy
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Siteman Cancer Center at Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
2
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
H
Hannah Linden
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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