Health Trials

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

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

Treatments tested in this trial

  • Abemaciclib
  • Anastrozole
  • Biospecimen Collection
  • Computed Tomography
  • Diagnostic Imaging Testing
  • Exemestane
  • Fludeoxyglucose F-18
  • Fluorine F 18 Fluoro Furanyl Norprogesterone
  • Fulvestrant
  • Gonadotropin-releasing Hormone Analog
  • Letrozole
  • Positron Emission Tomography
  • Tamoxifen
  • Therapeutic Estradiol

Treatment groups

60 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Washington

Lead sponsor

Breast Cancer Research Foundation

Collaborator

Source ClinicalTrials.gov