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Cyclin-dependent Kinase Inhibitor

Treatment (FFNP-PET/CT, estradiol, abemaciclib, ET) for Breast Cancer

Phase 2

Waitlist Available

Led By Hannah Linden

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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).

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).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is testing how well a type of imaging called FFNP-PET/CT can predict how well a drug called abemaciclib, used to treat certain types of breast cancer, will work

Who is the study for?

This trial is for individuals with advanced hormone receptor-positive, HER2-negative breast cancer. Participants should be suitable for functional imaging and abemaciclib treatment combined with endocrine therapy. Specific eligibility details are not provided.Check my eligibility

What is being tested?

The study tests if FFNP-PET/CT imaging can predict the response to abemaciclib plus endocrine therapy in treating certain breast cancers. Abemaciclib blocks proteins that may slow tumor growth, while endocrine therapy affects hormones related to cancer growth.See study design

What are the potential side effects?

Potential side effects of abemaciclib include diarrhea, fatigue, low white blood cell counts (neutropenia), nausea, abdominal pain, infections and liver enzyme elevation. Endocrine therapies may cause hot flashes, joint pain and osteoporosis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is ER+ and HER2-negative, making me a candidate for hormone therapy.

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My cancer is visible outside the liver and measures at least 1.5 cm, or it's seen on special scans.

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I am 18 years old or older.

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My liver function tests are within the required range.

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I have breast cancer that has spread or cannot be removed by surgery.

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I can take care of myself and am up and about more than half of the day.

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I am premenopausal and have been on GnRH agonist treatment for over 6 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Response to abemaciclib + endocrine therapy

Secondary outcome measures

Overall response rate (ORR)

Overall survival rate (OS)

Progression free survival rate (PFS)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (FFNP-PET/CT, estradiol, abemaciclib, ET)Experimental Treatment14 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gonadotropin-releasing Hormone Analog

2017

Completed Phase 2

~90

Computed Tomography

2017

Completed Phase 2

~2720

Anastrozole

2019

Completed Phase 4

~10300

Biospecimen Collection

2004

Completed Phase 2

~1700

Positron Emission Tomography

2008

Completed Phase 2

~2240

Abemaciclib

2019

Completed Phase 2

~1710

Exemestane

2003

Completed Phase 4

~7880

Tamoxifen

2005

Completed Phase 4

~30070

Fulvestrant

2011

Completed Phase 3

~3690

Letrozole

2002

Completed Phase 4

~2770

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,744 Previous Clinical Trials

1,848,317 Total Patients Enrolled

20 Trials studying Breast Cancer

3,253 Patients Enrolled for Breast Cancer

Breast Cancer Research FoundationOTHER

69 Previous Clinical Trials

137,670 Total Patients Enrolled

42 Trials studying Breast Cancer

130,477 Patients Enrolled for Breast Cancer

Hannah LindenPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium

10 Previous Clinical Trials

367 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots for new participants in this ongoing medical study?

"Based on the information available on clinicaltrials.gov, this specific study is not actively seeking participants. The trial was initially posted on June 1st, 2024 and last modified on December 11th, 2023. However, it's worth noting that there are currently a substantial number of other trials (4763 to be precise) actively recruiting participants at present."

Answered by AI

Has the FDA officially authorized the administration of Treatment (FFNP-PET/CT, estradiol, abemaciclib, ET) for therapeutic purposes?

"Based on our evaluation as a Phase 2 trial, the safety of Treatment (FFNP-PET/CT, estradiol, abemaciclib, ET) is estimated to be at level 2. While there is some existing data supporting its safety profile, no efficacy data has been established yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06179303.