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Functional Imaging for Abemaciclib in Advanced Breast Cancer

This study is looking at how well a special type of imaging, called FFNP-PET/CT, can predict if abemaciclib and hormone therapy will work for advanced hormone receptor-positive (HR+), HER2-negative breast cancer. Abemaciclib is a medication that helps stop cancer cells from growing by blocking certain proteins. Hormone therapy works by affecting hormones that can make cancer grow. You might be able to join if you have metastatic or locally advanced breast cancer that is HR+ and HER2-negative. The main goal is to see how well patients respond to abemaciclib and hormone therapy over up to two years. The current status of this study is unclear, and it plans to enroll 60 participants.

Study design
This is an interventional study that plans to enroll 60 participants. It is a Phase II trial, meaning it's testing the effectiveness and safety of the treatment.
What's involved
You would receive FFNP and undergo PET/CT scans at the start, then take estradiol for 24 hours followed by more FFNP and PET/CT. You would then take abemaciclib twice daily in cycles, along with endocrine therapy chosen by your doctor. You would also have regular diagnostic imaging and blood tests.
Compensation
Not stated in the trial record.
Follow-up
After the study treatment, you would be followed every 3 months. The primary endpoint for response to treatment is measured for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06179303

Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Washington
~60 participants
Updated 2026-04-16 on ClinicalTrials.gov
What's tested:AbemaciclibAnastrozoleBiospecimen CollectionComputed TomographyDiagnostic Imaging TestingExemestane

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Response to abemaciclib + endocrine therapy
Measured over Up to 2 years

Conditions

Anatomic Stage III Breast Cancer AJCC v8
Anatomic Stage IV Breast Cancer AJCC v8
Locally Advanced Unresectable HER2-Negative Breast Carcinoma
Locally Advanced Unresectable Hormone Receptor-Positive Breast Carcinoma
Metastatic HER2-Negative Breast Carcinoma
Metastatic Hormone Receptor-Positive Breast Carcinoma

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Breast Carcinoma

Where it's being run

2 sites across 2 states
Missouri1
Washington1

Study leadership

  • Hannah Linden · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium

Who to contact

Hannah Linden
[email protected]
206-606-2053
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Men or women with metastatic or locally advanced unresectable breast cancer
Histologically confirmed ER+ / HER2-negative, breast cancer who is a candidate for endocrine therapy with pathology from the primary tumor or metastatic/recurrent site. Based on American Society of Clinical Oncology/College of American Pathologists (ASCO CAP) Guidelines: ER+: \>= 1% of tumor cell nuclei to be immunoreactive. HER2-negative: HER2 of 0, 1+ by immunohistochemistry (IHC) or negative by fluorescence in situ hybridization (FISH).
In the case of bone biopsy which could yield false negative ER or PR status in patients with historically HR+ disease, a patient may be eligible if the treating physician and the study chair both agree that the patient is a candidate for further endocrine therapy (ET) based treatment.
Note that baseline PR status by IHC does not influence results of deltaFFNP-PET imaging.
If premenopausal, the patient has to be treated with GnRH agonist for at least 6 weeks prior to FFNP-PET.
Disease must be present in at least one non-liver site and measurable by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and be 1.5 cm or greater in longest dimension OR disease can be non-measurable but must be 1.5 cm in longest dimension on functional imaging (fluorodeoxyglucose \[FDG\]-PET/computed tomography \[CT\] preferred).
No limits to prior lines of endocrine therapy in the metastatic setting including synergistic targeted therapy such as CDK4/6 inhibitors (other than Abemaciclib), PI3K inhibitor, mTOR inhibitor, etc. One line of prior cytotoxic chemotherapy in the metastatic setting is allowed. Washout from prior systemic anti-cancer therapy of at least 2 weeks from chemotherapy or radiation, 2 weeks or 5 half lives (whichever is longer) from oral selective estrogen receptor degrader (SERD), 8 weeks from oral selective estrogen receptor modulator (SERM), and 16 weeks from intramuscular SERD (Fulvestrant) is required. Recovery of adverse events from the last therapy to grade 1 except alopecia. Patients may continue luteinizing hormone-releasing hormone (LHRH) agonist to remain post-menopausal without a need for washout
Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
At least 18 years of age
Absolute neutrophil count \>= 1,500/uL
Platelets \>= 100,000/uL
Hemoglobin \>= 9g/dL
Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN).
In case of known Gilbert's syndrome, \< 2 x ULN is allowed
Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT) /alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) =\< 2.5x institutional ULN, or =\< 5 x ULN for subjects with documented metastatic disease to the liver
eGFR (estimated glomerular filtration rate) ≥ 30 mL/min
Women of childbearing potential must agree to use adequate contraception (barrier method of birth control, abstinence) prior to study entry and for the duration of study participation
Ability to understand and willingness to sign an institutional review board (IRB)-approved written informed consent document (or that of legally authorizes representative, if applicable)
Consent to access archival tumor specimens for clinical sequencing data of tumor tissue and blood

Exclusion

Prior abemaciclib in the metastatic setting or within 2 years of completion of adjuvant abemaciclib
Hepatic-only metastatic disease
A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease
Currently receiving any other investigational agents
Untreated/unstable brain metastases. Patients with treated/stable brain metastases, defines as patients who have received prior therapy for their brain metastases and whose central nervous system (CNS) disease is radiographically stable at study entry, are eligible
A history of allergic reactions attributed to compounds of similar chemical or biologic composition to FFNP, abemaciclib, or other agents used in the study
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
Pregnant and/or breastfeeding women of childbearing potential must have a negative pregnancy test within 14 days of study entry. Male participants and female participants of childbearing potential must utilize adequate contraceptive methods throughout study treatment and for at least 30 days after the last dose of study medications
Patients with human immunodeficiency virus (HIV) are eligible unless their CD4+ T-cell counts are \< 350 cells/mcL or they have a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective antiretroviral therapy (ART) according to Department of Health and Human Services (DHHS) treatment guidelines is recommended

What this trial measures

  • Response to abemaciclib + endocrine therapyUp to 2 years

    Non-responding: progression within 24 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or death due to disease within 24 weeks or stable disease but lasting less than 24 weeks. Responding: defined as complete response (CR), partial response (PR) or stable disease lasting \>= 24 weeks. Quantitative deltaFFNP will be summarized by descriptive statistics (mean, median, standard deviation \[SD\], etc.) and tested against 0 by Wilcoxon signed rank test or paired t-test as appropriate, overall and by response. The dichotomized deltaFFNP will be summarized by count and percentages, overall and by response.