RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

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

Quick Facts

Study Start:2019-01-08

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03697577

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Histologically confirmed adenocarcinoma of the breast that is ER and/or PR positive, Her2 negative based on current 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. * 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.	* 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. * Recent radiation or chemotherapy within 4 weeks * 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 stereotatactic 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

Inclusion Criteria

Exclusion Criteria

* Histologically confirmed adenocarcinoma of the breast that is ER and/or PR positive, Her2 negative based on current 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.
* 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.

* 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.
* Recent radiation or chemotherapy within 4 weeks
* 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 stereotatactic 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

Contacts and Locations

Study Contact

Jesus Anampa, MD

CONTACT

718-405-8505

janampa@montefiore.org

Estefania Hernandez

CONTACT

718-405-8126

eshernande@montefiore.org

Principal Investigator

Jesus Anampa, MD

PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Study Locations (Sites)

Montefiore Medical Center

Bronx, New York, 10461

United States

Collaborators and Investigators

Sponsor: Montefiore Medical Center

Jesus Anampa, MD, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-01-08

Study Completion Date2025-12

Study Record Updates

Study Start Date2019-01-08

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Breast Cancer