CDK and Body Composition Study

NCT03697577 | Active Not Recruiting

• 1 other identifier: 2018-9567
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Breast Cancer

Keywords

cyclin-dependent kinase (CDK) 4/6 inhibitors; Body composition; body fat mass; metastatic ER+/HER2- breast cancer

Outcome Measures

Primary Outcomes (1)

• 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).

  From Baseline and 6 months after CDK 4/6 inhibitor therapy

Secondary Outcomes (17)

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

  Baseline and 6 months after CDK 4/6 inhibitor therapy

• Body Lean Mass (BLM) using Dual-energy X-ray Absorptiometry (DEXA)

  Baseline and 6 months after CDK 4/6 inhibitor therapy

• Skeletal muscle index (SMI)

  Baseline and 6 months after CDK 4/6 inhibitor therapy

• Adipose Serum Biomarkers - Fasting Glucose

  Baseline and 6 months after CDK 4/6 inhibitor therapy

• Adipose Serum Biomarkers - Lipid Panel (Total Cholesterol and LDL cholesterol, HDL cholesterol, and Triglycerides)

  Baseline and 6 months after CDK 4/6 inhibitor therapy

Study Arms (1)

ER+/HER2- metastatic breast cancer

Subjects have metastatic ER+/HER2- breast cancer, and their doctor is offering treatment with CDK 4/6 inhibitors as standard of care treatment. It is hypothesized that cyclin-dependent kinase (CDK) 4/6 inhibitors decrease fat mass among women with ER+/HER2- metastatic breast cancer without significant effect in the skeletal mass. Body composition will be obtained from CT scans (CT or PETCT) as part of standard of care, and body fat mass will be obtained from DEXA scan (DEXA will be performed only if available)

Diagnostic Test: CT scans; Diagnostic Test: DEXA scan

Interventions

CT scans DIAGNOSTIC_TEST

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

ER+/HER2- metastatic breast cancer

DEXA scan DIAGNOSTIC_TEST

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

ER+/HER2- metastatic breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are being asked to participate in this study because they have metastatic ER+/HER2- breast cancer, and their doctor is offering treatment with CDK 4/6 inhibitors as standard of care treatment.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Total Number of Specimens 60 Project/Storage Duration: 24 Months Sample Type: BLOOD-SERUM Specimen Volume: 15cubic centimeters (15cc) Sample Preservation Measures: STANDARD

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tomography, X-Ray Computed; Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Jesus Anampa, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 5, 2018
• Study Start: January 8, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)