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

ConditionsAnatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Locally Advanced Unresectable HER2-Negative Breast CarcinomaLocally Advanced Unresectable Hormone Receptor-Positive Breast CarcinomaMetastatic HER2-Negative Breast CarcinomaMetastatic Hormone Receptor-Positive Breast Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Abemaciclib

    Drug

    Given PO

  • Anastrozole

    Drug

    Given PO

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Diagnostic Imaging Testing

    Procedure/Surgery

    Undergo clinical imaging for tumor assessment

  • Exemestane

    Drug

    Given PO

  • Fludeoxyglucose F-18

    Other intervention

    Given IV

  • Fluorine F 18 Fluoro Furanyl Norprogesterone

    Drug

    Given IV

  • Fulvestrant

    Drug

    Given IM injection

  • Gonadotropin-releasing Hormone Analog

    Biological/Vaccine

    Given GnRH analog

  • Letrozole

    Drug

    Given PO

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Tamoxifen

    Drug

    Given PO

  • Therapeutic Estradiol

    Drug

    Given PO

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Treatment (FFNP-PET/CT, estradiol, abemaciclib, ET)Experimental treatment 14 interventions

Trial outcomes

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.

Time frame
Up to 2 years

Secondary outcomes

1

Overall response rate (ORR)

Defined by RECIST 1.1

Time frame
Up to 2 years
2

Progression free survival rate (PFS)

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.

Time frame
Up to 2 years
3

Overall survival rate (OS)

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

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Washington

Lead sponsor

Breast Cancer Research Foundation

Collaborator

Source ClinicalTrials.gov
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