CDK and Body Composition Study

N/AActive Not RecruitingNCT03697577

Montefiore Medical Center30 enrolled

Overview

The goal of this study is to evaluate changes in body composition among patients who are treated with cyclin-dependent kinase (CDK) 4/6 inhibitors (abemaciclib, ribociclib, or palbociclib).

The goal of this study is to evaluate changes in body composition among patients who are treated with cyclin-dependent kinase (CDK) 4/6 inhibitors (abemaciclib, ribociclib, or palbociclib). There is preliminary data suggesting that these drugs have more effect on body fat mass than body muscle mass. These drugs have already been approved by U.S Food and Drug Administration (FDA) to treat ER+/HER2- metastatic breast cancer. The investigators will follow up body composition changes among patients who receive CDK 4/6 inhibitors as part of their standard of care. Body composition changes will be measured from Computed Tomography (CT) or Positron Emission Tomography/Computed Tomography (PET/CT) scans that are part of standard of care treatment, and from DEXA scans (DEXA is optional and will be performed only if available). The investigators will also conduct body measurements with measuring tape and will draw blood tests to assess for fat biomarkers.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Breast Cancer

Interventions

CT scansDIAGNOSTIC_TEST

Patients will undergo CT or PETCT as part of standard of care

DEXA scanDIAGNOSTIC_TEST

Patients will undergo DEXA scan to measure body fat mass (DEXA will be performed only if available)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically confirmed adenocarcinoma of the breast that is Estrogen Receptor (ER) and/or Progesterone Receptor (PR) positive based on current American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) guidelines * Metastatic or locally advanced/inflammatory, unresectable breast cancer not amenable to potentially curative surgery * Measurable and/or non-measurable as defined by RECIST 1.1 criteria * Patients must be a candidate to start an FDA approved CDK 4/6 inhibitor (palbociclib, ribociclib, abemaciclib) as part of standard of care treatment * Female, or male patients, and age \>=18 years * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Ability to understand and the willingness to sign a written informed consent document * Concomitant therapy with bisphosphonates, RANKL inhibitors or growth-colony-stimulating factor (G-CSF) is allowed as per physician decision Exclusion Criteria: * History of allergic reactions attributed to compounds of similar chemical or biologic composition to CDK 4/6 inhibitors or other agents used in the study (e.g., fulvestrant, letrozole, anastrozole, exemestane) * BMI \< 18.5 * Prior CDK 4/6 use in any setting * Inability to undergo anthropometric measurements * Inability to undergo CT scan imaging * Women of child-bearing potential must not be pregnant or breast feeding. They must also agree to use adequate contraception (hormonal or barrier method of birth control) and not be breast feeding prior to study entry, for the duration of study participation, and for up to 10 days after completion of all protocol therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study or up to 10 days after completion of protocol therapy, she should inform her treating physician immediately * Intercurrent illness that would substantially increase the risk of treatment associated complications (e.g., active infection, uncontrolled diabetes mellitus or hypertension) * Psychiatric illness/social situations that would interfere with the patient's ability to comply with the treatment regimen * Patients with untreated brain metastasis are excluded. Patients with a prior history of brain metastasis are eligible if they have received prior brain radiation (whole brain or stereotactic radiosurgery) or surgery, have stable intracranial disease for at least 3 months after completion of local therapy, and are not taking corticosteroids for treatment of brain metastasis * Patients who have not recovered (i.e., CTCAE Grade ≤1 or baseline) from an adverse event due to a previously administered agent, excluding alopecia * Patients with inability to swallow and retain pills * Malabsorption syndrome or other gastrointestinal illness that could affect oral absorption * Patients with active implanted medical devices (cardiac pacemakers, defibrillators or patients connected to electronic life support devices)

Locations (1)

Montefiore Medical Center

The Bronx, New York, United States

Outcomes

Primary Outcomes

Change in Total adipose tissue (TAT)

Total Adipose tissue (TAT) is defined as the sum of intramuscular adipose tissue (IMAT), visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT) obtained from L3 cross section from CT scans. Only patients who complete 24 weeks of CDK 4/6 inhibitor treatment and have no radiological/clinical signs of disease progression will be included in the analysis of primary endpoint. Results will be calculated and summarized in area (cm²).

Time frame: From Baseline and 6 months after CDK 4/6 inhibitor therapy

Secondary Outcomes

Body Fat Mass (BFM) using Dual-energy X-ray Absorptiometry (DEXA)

Body Fat Mass will be obtained from dual-energy x-ray absorptiometry (DEXA). The DEXA scan calculates the ratio of soft tissue attenuation at different X-ray energies. Results are measured and reported in kilograms (kg). DEXA scans are optional and will be performed only if available.