Recruiting

Functional Imaging and Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer

Study Aim

This study aims to evaluate the response to abemaciclib combined with endocrine therapy in adults with advanced hormone receptor-positive, HER2-negative breast cancer, defining response as complete response, partial response, or stable disease lasting for at least 24 weeks.

What is being tested

Abemaciclib

+ Anastrozole

+ Biospecimen Collection

DrugProcedureOtherBiological

Who is being recruted

Over 18 Years

+19 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: July 2024

See protocol details

Summary

Principal SponsorUniversity of Washington

Study ContactHannah Linden

Last updated: January 31, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 22, 2024

Actual date on which the first participant was enrolled.

This study aims to improve treatment for patients with advanced hormone receptor-positive, HER2-negative breast cancer by using functional imaging to predict how well they respond to a medication called Abemaciclib. The study focuses on individuals who have this specific type of breast cancer, which is an advanced stage and often requires new strategies for effective management. By understanding how the body responds to this treatment through detailed imaging, doctors hope to tailor treatments more effectively and potentially improve outcomes for these patients. Participants in the study receive an imaging agent called FFNP through an IV and undergo PET/CT scans to see how their cancer is behaving at the start. They then take a hormone pill, estradiol, for a day, followed by another round of imaging. After this, they take Abemaciclib pills twice a day in 28-day cycles, as long as the treatment is working and safe. Every three cycles, additional imaging is done to check on the tumor's response. Blood samples are also collected throughout to monitor the treatment's effects. The study involves regular follow-ups every three months after it ends to ensure continued patient care.

Official TitleA Phase II Trial to Evaluate Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer

NCT06179303

Principal SponsorUniversity of Washington

Study ContactHannah Linden

Last updated: January 31, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

12 inclusion criteria required to participate

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).

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.

Show More Criteria

7 exclusion criteria prevent from participating

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Fred Hutch/University of Washington Cancer Consortium

Seattle, United StatesOpen Fred Hutch/University of Washington Cancer Consortium in Google Maps

Suspended

Siteman Cancer Center at Washington University

St Louis, United States

Recruiting

2 Study Centers