Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer
A Phase II Trial to Evaluate Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer
3 other identifiers
interventional
60
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2024
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2023
CompletedFirst Posted
Study publicly available on registry
December 21, 2023
CompletedStudy Start
First participant enrolled
July 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
April 16, 2026
April 1, 2026
2.6 years
December 8, 2023
April 14, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Response to abemaciclib + endocrine therapy
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.
Up to 2 years
Secondary Outcomes (3)
Overall response rate (ORR)
Up to 2 years
Progression free survival rate (PFS)
Up to 2 years
Overall survival rate (OS)
Up to 2 years
Study Arms (1)
Treatment (FFNP-PET/CT, estradiol, abemaciclib, ET)
EXPERIMENTALPatients 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.
Interventions
Undergo clinical imaging for tumor assessment
Given IV
Given IM injection
Given GnRH analog
Given PO
Undergo PET/CT
Given PO
Given PO
Undergo PET/CT
Undergo blood sample collection
Given IV
Given PO
Given PO
Eligibility Criteria
You may qualify if:
- 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
- +4 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- Breast Cancer Research Foundationcollaborator
Study Sites (2)
Siteman Cancer Center at Washington University
St Louis, Missouri, 63110, United States
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hannah Linden
Fred Hutch/University of Washington Cancer Consortium
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2023
First Posted
December 21, 2023
Study Start
July 22, 2024
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
June 1, 2028
Last Updated
April 16, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share