Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer
NCT ID: NCT06179303
Last Updated: 2025-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2024-07-22
2028-06-01
Brief Summary
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Detailed Description
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Patients receive FFNP intravenously (IV) and undergo PET/CT imaging at baseline. Patients then receive estradiol orally every 8 hours (Q8H) over a 24-hour period, followed again by FFNP IV and PET/CT imaging. Patients then receive abemaciclib orally (PO) twice daily (BID) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive endocrine therapy (ET) of the treating physician choice. Patients also receive FDG IV and undergo PET/CT imaging at baseline, with additional diagnostic imaging for tumor assessment every 3 cycles, and undergo blood sample collection throughout the study.
After study completion of study, patients are followed every 3 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (FFNP-PET/CT, estradiol, abemaciclib, ET)
Patients receive FFNP IV and undergo PET/CT imaging at baseline. Patients then receive estradiol orally Q8H over a 24-hour period, followed again by FFNP IV and PET/CT imaging. Patients then receive abemaciclib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive ET of the treating physician choice. Patients also receive FDG IV and undergo PET/CT imaging at baseline, with additional diagnostic imaging for tumor assessment every 3 cycles, and undergo blood sample collection throughout the study.
Fluorine F 18 Fluoro Furanyl Norprogesterone
Given IV
Fulvestrant
Given IM injection
Gonadotropin-releasing Hormone Analog
Given GnRH analog
Letrozole
Given PO
Positron Emission Tomography
Undergo PET/CT
Tamoxifen
Given PO
Therapeutic Estradiol
Given PO
Abemaciclib
Given PO
Anastrozole
Given PO
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo PET/CT
Diagnostic Imaging Testing
Undergo clinical imaging for tumor assessment
Exemestane
Given PO
Fludeoxyglucose F-18
Given IV
Interventions
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Fluorine F 18 Fluoro Furanyl Norprogesterone
Given IV
Fulvestrant
Given IM injection
Gonadotropin-releasing Hormone Analog
Given GnRH analog
Letrozole
Given PO
Positron Emission Tomography
Undergo PET/CT
Tamoxifen
Given PO
Therapeutic Estradiol
Given PO
Abemaciclib
Given PO
Anastrozole
Given PO
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo PET/CT
Diagnostic Imaging Testing
Undergo clinical imaging for tumor assessment
Exemestane
Given PO
Fludeoxyglucose F-18
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Breast Cancer Research Foundation
OTHER
University of Washington
OTHER
Responsible Party
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Principal Investigators
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Hannah Linden
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Siteman Cancer Center at Washington University
St Louis, Missouri, United States
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2022-06409
Identifier Type: REGISTRY
Identifier Source: secondary_id
FHIRB0020029
Identifier Type: OTHER
Identifier Source: secondary_id
RG1122019
Identifier Type: -
Identifier Source: org_study_id
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