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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
University of Washington
Study ID
NCT06179303
Phase
PHASE2
Status
Recruiting
Apply to this trial

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abemaciclib — DRUG
    Given PO
  • Anastrozole — DRUG
    Given PO
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo PET/CT
  • Diagnostic Imaging Testing — PROCEDURE
    Undergo clinical imaging for tumor assessment
  • Exemestane — DRUG
    Given PO
  • Fludeoxyglucose F-18 — OTHER
    Given IV
  • Fluorine F 18 Fluoro Furanyl Norprogesterone — DRUG
    Given IV
  • Fulvestrant — DRUG
    Given IM injection
  • Gonadotropin-releasing Hormone Analog — BIOLOGICAL
    Given GnRH analog
  • Letrozole — DRUG
    Given PO
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Tamoxifen — DRUG
    Given PO
  • Therapeutic Estradiol — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Jul 22, 2024
Status verified
Apr 2026
Primary completion
Mar 1, 2027
Completion
Jun 1, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Response to abemaciclib + endocrine therapy [ Time Frame: Up to 2 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Siteman Cancer Center at Washington UniversitySt LouisMissouri63110
Farrokh Dehdashti
[email protected]
314-362-2809
Farrokh Dehdashti (PRINCIPAL_INVESTIGATOR)
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Hannah Linden
[email protected]
206-606-2053
Hannah Linden (PRINCIPAL_INVESTIGATOR)

Find similar trials in St Louis, MO

By research site
Siteman Cancer Center at Washington University· St Louis, MOFred Hutch/University of Washington Cancer Consortium· Seattle, WA

Related Studies