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Breast CancerNCT03697577

CDK and Body Composition Study

An observational study of Breast Cancer, run by Montefiore Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
CT scans and DEXA scan
How many people
30 participants
Where
1 siteUnited States
Study dates
8 Jan 2019to 8 Jul 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Montefiore Medical Center

    The Bronx, New York, 10461

Other trials in United States

About this study

Official title: Pilot Study Assessing the Effect of Cyclin-dependent Kinase 4/6 Inhibitors on Body Composition in Patients With ER+/HER2- Metastatic Breast Cancer

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).

Read the detailed description

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.

Conditions
Breast Cancer
Being tested
CT scans, DEXA scan
Keywords
cyclin-dependent kinase (CDK) 4/6 inhibitors, Body composition, body fat mass, metastatic ER+/HER2- breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)

Study groups in NCT03697577
Study groupRoleWhat they receive
ER+/HER2- metastatic breast cancerSubjects 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)
Receives: Diagnostic Test: CT scans; Diagnostic Test: DEXA scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (17)

  1. 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.

    Measured: Baseline and 6 months after CDK 4/6 inhibitor therapy

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

    Body Lean Mass (BLM) 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.

    Measured: Baseline and 6 months after CDK 4/6 inhibitor therapy

  3. Skeletal muscle index (SMI)

    Skeletal muscle index (SMI) will be obtained by dual-energy x-ray absorptiometry (DEXA). The DEXA scan will be used to measure the amount of lean muscle in the body. SMI is defined as muscle area at L3 cross section from CT scans in cm^2 divided by height in meters squared. DEXA scans are optional and will be performed only if available.

    Measured: Baseline and 6 months after CDK 4/6 inhibitor therapy

  4. Adipose Serum Biomarkers - Fasting Glucose

    Fasting glucose levels in blood sera will be measured using a glucose blood sugar test. Normal ranges vary based on the health of the individual however standard glucose concentrations are between 70 mg/dL (3.9 mmol/L) -100 mg/dL (5.6 mmol/L). Glucose levels between 100-125 mg/dL (5.6-6.9 mmol/L) may be indicative of prediabetes. Fasting glucose levels >126 mg/dL on successive tests is correlated with diabetes. Results will be summarized and reported.

    Measured: Baseline and 6 months after CDK 4/6 inhibitor therapy

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

    A lipid panel will be used to assess Total cholesterol, LDL Cholesterol, HDL Cholesterol, and triglyceride levels in blood sera samples. Each parameter has unique ranges and can vary by age, weight, and sex; however, High concentrations of Total cholesterol and LDL cholesterol increases the risk of coronary heart disease and atherosclerosis. HDL cholesterol ("good cholesterol") removes excess cholesterol from the body. High triglyceride levels also increase the risk of cardiovascular disease. Results for each parameter will be summarized and reported in mg/dL.

    Measured: Baseline and 6 months after CDK 4/6 inhibitor therapy

  6. Adipose Serum Biomarkers - Dehydroepiandrosterone Sulphate (DHEAS)

    DHEAS levels in blood sera will be measured using a DHEA-sulfate (DHEAS) blood test. This test can be used to check the function of the adrenal glands. Normal ranges vary based on age, gender and laboratory; however, high concentrations could be indicative of adrenal tumors, Cushing's disease, polycystic ovary syndrome (PCOS), or adrenal hyperplasia. Results will be summarized and reported in ug/dL.

    Measured: Baseline and 6 months after CDK 4/6 therapy

  7. Adipose Serum Biomarkers - Insulin

    Insulin levels in blood sera will be measured using an insulin blood test. Insulin is a hormone that regulates glucose absorption. Normal ranges vary based on the type of test administered and the health of the individual; however, standard fasting insulin concentrations are usually <25 mIU/L. Higher concentrations can be indicative of insulin resistance. Results will be summarized and reported.

    Measured: Baseline and 6 months after CDK 4/6 inhibitor therapy

  8. Adipose Serum Biomarkers - Leptin

    Leptin will be assessed using a leptin blood test that measures the concentration of leptin in blood sera. Leptin is a hormone that helps regulate appetite and energy levels. Standard ranges vary based on age, gender, body mass index, and other variables; however, ranges are generally between 0.5-15.2 ng/mL for females and 0.5-12.5 ng/mL for males. Results will be summarized and reported.

    Measured: Baseline and 6 months after CDK 4/6 inhibitor therapy

  9. Adipose Serum Biomarkers - Free Leptin Index (FLI)

    FLI will be assessed by blood test and calculated as the ratio of total leptin and soluble leptin receptor (sOB-R) concentrations. FLI is a biomarker of leptin resistance and the status of leptin action. High FLI is a risk factor for obesity and is associated with several chronic diseases. Results will be summarized and reported.

    Measured: Baseline and 6 months after CDK 4/6 inhibitor therapy

  10. Adipose Serum Biomarkers - Adiponectin

    Adiponectin will be assessed using an adiponectin test that measures the concentration of adiponectin in the blood. Adiponectin is a protein hormone produced by fat cells that helps regulate blood sugar and fat metabolism. Lower levels of adiponectin in blood sera are often linked to conditions like obesity, type 2 diabetes, and heart disease. A normal adiponectin blood test result is generally 5-30 ug/mL but can vary depending on age and body mass index (BMI). Results will be summarized and reported.

    Measured: Baseline and 6 months after CDK 4/6 inhibitor therapy

  11. Adipose Serum Biomarkers - High-sensitivity C-reactive protein (hsCRP)

    hsCRP will be measured and reported by blood test. hsCRP measures the concentration of C-reactive protein (CRP) in blood. CRP is a protein that increases in response to inflammation and is correlated with adverse cardiovascular and cerebrovascular outcomes. Normal results are generally risk stratified with concentrations <1.0 mg/dL indicating a low risk of cardiovascular disease; concentrations between 1.0-3.0 mg/dL indicating an average risk of cardiovascular disease; and concentrations >3.0 mg/dL indicating a high risk of cardiovascular disease. Results will be summarized and reported.

    Measured: Baseline and 6 months after CDK 4/6 inhibitor therapy

  12. Body Fat Mass (BFM) using Bioimpedance spectroscopy (BIS)

    BFM will be measured with the use of bioimpedance spectroscopy (BIS). BIS is a non-invasive method that takes measurements at 256 different frequencies and uses mathematical modeling to calculate electrical resistance throughout the body. Fat tissue has significantly higher resistance compared to lean muscle tissue. The total weight of body fat estimated by the BIS analysis will be expressed in kilograms and summarized for the group.

    Measured: Baseline and 6 months after CDK 4/6 inhibitor therapy

  13. Body Fat-Free Mass (FFM)

    FFM will be derived based on the BFM readout obtained from the BIS analysis. The "fat-free mass" will be calculated by subtracting the total body weight minus the estimated BFM obtained by BIS analysis, based on electrical resistance through the body. This result will be expressed in kilograms and summarized for the group.

    Measured: Baseline and 6 months after CDK 4/6 inhibitor therapy

  14. Anthropometric measurements - Body Mass Index (BMI)

    BMI will be determined by obtaining height and body weight measurements. It is calculated by dividing body weight in kilograms (kg) by height in meters squared (m^2). A BMI of 30 kg/m^2 or higher has been used to define obesity in most reports, including those showing an association between obesity and increased risk of cancers, cancer mortality, and mortality from all causes. Group results will be summarized and reported.

    Measured: Baseline and 6 months after CDK 4/6 inhibitor therapy

  15. Anthropometric measurements - Skin fold thickness (biceps, triceps, subscapular, and suprailiac)

    Skin fold thickness will be measured with the use of calipers. Skin fold thickness measurements will be obtained for the biceps, triceps, subscapular, and suprailiac sites. Calipers will be used to pinch the skin and lift it away from the muscle at each site and measure the thickness of skin folds at each location. Values will be summarized in millimeters (mm) for the group and reported. Skin fold thickness measurements provide an overall picture of subcutaneous fat distribution.

    Measured: Baseline and 6 months after CDK 4/6 inhibitor therapy

  16. Anthropometric measurements - Abdominal circumference

    Abdominal circumference is a measurement of the horizontal distance around the abdomen. Abdominal circumference will be assessed by determining the midpoint between the lower rib margin and the iliac crest and measuring the circumference at the midpoint, in centimeters, with measuring tape while breathing normally. Group results will be summarized. An enlarged abdominal circumference can be a sign of obesity and a risk factor for disease.

    Measured: Baseline and 6 months after CDK 4/6 inhibitor therapy

  17. Anthropometric measurements - Waist-to-hip ratio

    Waist-to-hip ratio will be measured with measuring tape by measuring the narrowest part of the waist followed by the widest part of the hips and dividing the waist measurement by the hip measurement. While normal values can vary, a healthy waist-to-hip ratio is generally considered to be below 0.9 for men and 0.85 for women, according to the World Health Organization (WHO). Group results will be summarized.

    Measured: Baseline and 6 months after CDK 4/6 inhibitor therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2018
  2. Study start8 Jan 2019
  3. Primary completion8 Jul 2026
  4. Study completion8 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03697577
Sponsor's protocol ID
2018-9567
Status last verified
Sep 2026
First submitted
2 Oct 2018
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Flegal KM, Carroll MD, Ogden CL, Curtin LR. Prevalence and trends in obesity among US adults, 1999-2008. JAMA. 2010 Jan 20;303(3):235-41. doi: 10.1001/jama.2009.2014. Epub 2010 Jan 13.

    PubMed 20071471

  • Ryan DH, Kushner R. The state of obesity and obesity research. JAMA. 2010 Oct 27;304(16):1835-6. doi: 10.1001/jama.2010.1531. Epub 2010 Oct 9. No abstract available.

    PubMed 20935336

  • Renehan AG, Tyson M, Egger M, Heller RF, Zwahlen M. Body-mass index and incidence of cancer: a systematic review and meta-analysis of prospective observational studies. Lancet. 2008 Feb 16;371(9612):569-78. doi: 10.1016/S0140-6736(08)60269-X.

    PubMed 18280327

  • Finkelstein EA, Khavjou OA, Thompson H, Trogdon JG, Pan L, Sherry B, Dietz W. Obesity and severe obesity forecasts through 2030. Am J Prev Med. 2012 Jun;42(6):563-70. doi: 10.1016/j.amepre.2011.10.026.

    PubMed 22608371

  • Myers MG Jr, Heymsfield SB, Haft C, Kahn BB, Laughlin M, Leibel RL, Tschop MH, Yanovski JA. Challenges and opportunities of defining clinical leptin resistance. Cell Metab. 2012 Feb 8;15(2):150-6. doi: 10.1016/j.cmet.2012.01.002.

    PubMed 22326217

  • Ring LE, Zeltser LM. Disruption of hypothalamic leptin signaling in mice leads to early-onset obesity, but physiological adaptations in mature animals stabilize adiposity levels. J Clin Invest. 2010 Aug;120(8):2931-41. doi: 10.1172/JCI41985. Epub 2010 Jul 1.

    PubMed 20592471

  • Dhillon H, Zigman JM, Ye C, Lee CE, McGovern RA, Tang V, Kenny CD, Christiansen LM, White RD, Edelstein EA, Coppari R, Balthasar N, Cowley MA, Chua S Jr, Elmquist JK, Lowell BB. Leptin directly activates SF1 neurons in the VMH, and this action by leptin is required for normal body-weight homeostasis. Neuron. 2006 Jan 19;49(2):191-203. doi: 10.1016/j.neuron.2005.12.021.

    PubMed 16423694

  • Peruzzo B, Pastor FE, Blazquez JL, Schobitz K, Pelaez B, Amat P, Rodriguez EM. A second look at the barriers of the medial basal hypothalamus. Exp Brain Res. 2000 May;132(1):10-26. doi: 10.1007/s002219900289.

    PubMed 10836632

  • McNay DE, Briancon N, Kokoeva MV, Maratos-Flier E, Flier JS. Remodeling of the arcuate nucleus energy-balance circuit is inhibited in obese mice. J Clin Invest. 2012 Jan;122(1):142-52. doi: 10.1172/JCI43134. Epub 2011 Dec 27.

    PubMed 22201680

  • Li J, Tang Y, Cai D. IKKbeta/NF-kappaB disrupts adult hypothalamic neural stem cells to mediate a neurodegenerative mechanism of dietary obesity and pre-diabetes. Nat Cell Biol. 2012 Oct;14(10):999-1012. doi: 10.1038/ncb2562. Epub 2012 Sep 2.

    PubMed 22940906

  • Lee DA, Bedont JL, Pak T, Wang H, Song J, Miranda-Angulo A, Takiar V, Charubhumi V, Balordi F, Takebayashi H, Aja S, Ford E, Fishell G, Blackshaw S. Tanycytes of the hypothalamic median eminence form a diet-responsive neurogenic niche. Nat Neurosci. 2012 Mar 25;15(5):700-2. doi: 10.1038/nn.3079.

    PubMed 22446882

  • Thaler JP, Guyenet SJ, Dorfman MD, Wisse BE, Schwartz MW. Hypothalamic inflammation: marker or mechanism of obesity pathogenesis? Diabetes. 2013 Aug;62(8):2629-34. doi: 10.2337/db12-1605. No abstract available.

    PubMed 23881189

  • Ozcan L, Ergin AS, Lu A, Chung J, Sarkar S, Nie D, Myers MG Jr, Ozcan U. Endoplasmic reticulum stress plays a central role in development of leptin resistance. Cell Metab. 2009 Jan 7;9(1):35-51. doi: 10.1016/j.cmet.2008.12.004.

    PubMed 19117545

  • Jemal A, Center MM, DeSantis C, Ward EM. Global patterns of cancer incidence and mortality rates and trends. Cancer Epidemiol Biomarkers Prev. 2010 Aug;19(8):1893-907. doi: 10.1158/1055-9965.EPI-10-0437. Epub 2010 Jul 20.

    PubMed 20647400

  • Reggiani F, Bertolini F. Roles of obesity in the development and progression of breast cancer. Discov Med. 2017 Nov;24(133):183-190.

    PubMed 29278671

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by Montefiore Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Total adipose tissue (TAT) (time frame: From Baseline and 6 months after CDK 4/6 inhibitor therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03697577, which also lists 47 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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CDK and Body Composition Study (NCT03697577) | AzTrials