Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Bone Density Conservation Agents

Antineoplastic Agents

All Drugs and Chemicals

Reproductive Control Agents

Anti-Infective Agents

Tamoxifen

Hormones

Fluorides

Fluorodeoxyglucose F18

Fulvestrant

Exemestane

Letrozole

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Estradiol

Polyestradiol phosphate

Prolactin Release-Inhibiting Factors

Anastrozole

Deoxyglucose

Hormone Antagonists

Estrogens

Contraceptive Agents

Contraceptive Agents, Hormonal

Contraceptive Agents, Female

Aromatase Inhibitors

Enzyme Inhibitors

Estrogen Antagonists

Estrogen Receptor Antagonists

Antineoplastic Agents, Hormonal

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

Radiopharmaceuticals

Protective Agents

Antimetabolites

Antiviral Agents

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.

Abemaciclib

Biospecimen Collection

Computed Tomography

Undergo clinical imaging for tumor assessment

Diagnostic Imaging

Fludeoxyglucose F-18

Fluorine F 18 Fluoro Furanyl Norprogesterone

Gonadotropin-releasing Hormone Analog

Positron Emission Tomography

Therapeutic Estradiol

Hannah Linden

Farrokh Dehdashti

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.

OUTLINE:

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.

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

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.

Defined from date on study to date of progression or date of death or date of last clinical follow up with imaging evidence showing no progression if a patient did not progress or die, whichever the earliest. PFS events include progression and death.

Defined from date on study to date of death or last follow up if a patient is still alive.

Breast Cancer Research Foundation

University of Washington

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer	NCT06179303	Anatomic Stage ... Anatomic Stage ... Locally Advance... Locally Advance... Metastatic HER2... Metastatic Horm...	Abemaciclib Anastrozole Biospecimen Col... Computed Tomogr... Diagnostic Imag... Exemestane Fludeoxyglucose... Fluorine F 18 F... Fulvestrant Gonadotropin-re... Letrozole Positron Emissi... Tamoxifen Therapeutic Est...	18 Years -	University of Washington
Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer	NCT06179303	Anatomic Stage ... Anatomic Stage ... Locally Advance... Locally Advance... Metastatic HER2... Metastatic Horm...	Abemaciclib Anastrozole Biospecimen Col... Computed Tomogr... Diagnostic Imag... Exemestane Fludeoxyglucose... Fluorine F 18 F... Fulvestrant Gonadotropin-re... Letrozole Positron Emissi... Tamoxifen Therapeutic Est...	18 Years -	University of Washington

Spots Global Cancer Trial Database for fluorine f 18 fluoro furanyl norprogesterone