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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03697577
• Other study ID #: 2018-9567
• Status: Recruiting
• Start date: January 8, 2019
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Montefiore Medical Center
• Contact: Jesus Anampa, MD
• Phone: 718-405-8505
• Email: janampa[@]montefiore.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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 CT or PET/CT scans that are part of standard of care treatment, and from DEXA scans (as part of proposed study). The investigators will also conduct body measurements with measuring tape, and will draw blood tests to assess for fat biomarkers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion 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.

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.
• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• CT scans
Patients will undergo CT or PETCT as part of their standard of care
• DEXA scan
Patients will undergo DEXA scan to measure body fat mass. This is part of proposed study.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months
Secondary	Body fat mass (BFM)	body fat mass will be obtained from dual-energy x-ray absorptiometry (DEXA).	24 months
Secondary	Body lean mass (BLM)	body lean mass(BLM) will be obtained from dual-energy x-ray absorptiometry (DEXA).	24 months
Secondary	Skeletal muscle index (SMI)	Skeletal muscle index (SMI) is defined as muscle area at L3 cross section from CT scans in cm2 divided by height in meters squared	24 months
Secondary	Glucose	serum glucose will be measured	24 months
Secondary	Waist-to-hip ratio	waist-to-hip ratio will be measured with measuring tape.	24 months