Pilot Study Assessing the Effect of Cyclin-dependent Kinase 4/6 Inhibitors on Body Composition in Patients With ER+/HER2- Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03697577|
Recruitment Status : Recruiting
First Posted : October 5, 2018
Last Update Posted : December 13, 2021
|Condition or disease||Intervention/treatment|
|Breast Cancer||Diagnostic Test: CT scans Diagnostic Test: DEXA scan|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|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|
|Actual Study Start Date :||January 8, 2019|
|Estimated Primary Completion Date :||December 1, 2022|
|Estimated Study Completion Date :||December 1, 2023|
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.We hypothesize 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 their standard of care, and body fat mass will be obtained from DEXA scan(as part of proposed study)
Diagnostic Test: CT scans
Patients will undergo CT or PETCT as part of their standard of care
Diagnostic Test: DEXA scan
Patients will undergo DEXA scan to measure body fat mass. This is part of proposed study.
- Total adipose tissue (TAT) [ Time Frame: 24 months ]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.
- Body fat mass (BFM) [ Time Frame: 24 months ]body fat mass will be obtained from dual-energy x-ray absorptiometry (DEXA).
- body lean mass(BLM) [ Time Frame: 24 months ]body lean mass(BLM) will be obtained from dual-energy x-ray absorptiometry (DEXA).
- Skeletal muscle index (SMI) [ Time Frame: 24 months ]Skeletal muscle index (SMI) is defined as muscle area at L3 cross section from CT scans in cm2 divided by height in meters squared
- glucose [ Time Frame: 24 months ]serum glucose will be measured
- waist-to-hip ratio [ Time Frame: 24 months ]waist-to-hip ratio will be measured with measuring tape.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03697577
|Contact: Jesus Anampa, MDemail@example.com|
|Contact: Karen Fehn, RNfirstname.lastname@example.org|
|United States, New York|
|Montefiore Medical Center||Recruiting|
|Bronx, New York, United States, 10461|
|Contact: Jesus D Anampa, MD,MS 718-405-8505 email@example.com|
|Contact: Karen Fehn, RN 7184058505 firstname.lastname@example.org|
|Principal Investigator: Jesus Anampa, MD|
|Sub-Investigator: Joseph Sparano, MD|
|Principal Investigator:||Jesus Anampa, MD||Montefiore Medical Center|