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CDK and Body Composition Study | Clinical Trials | Clareo Health

RECRUITING

CDK and Body Composition Study

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

NCT03697577•Montefiore Medical Center

View on ClinicalTrials.gov

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).

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
•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
+2 more criteria

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

Locations (1)

Montefiore Medical Center

The Bronx, New York, United States

Key Dates

Start Date

January 8, 2019

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

January 23, 2026

Enrollment

ESTIMATED participants

Conditions

Breast Cancer

Interventions

CT scans

DIAGNOSTIC_TEST

DEXA scan

DIAGNOSTIC_TEST

Contacts

Jesus Anampa, MD

CONTACT

718-405-8505 janampa@montefiore.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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CDK and Body Composition Study

Inclusion Criteria

Exclusion Criteria

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