Who is sponsoring NCT03697577?

NCT03697577 is sponsored by Montefiore Medical Center.

What condition does NCT03697577 study?

NCT03697577 studies Breast Cancer.

What drugs are being tested in NCT03697577?

Interventions: CT scans, DEXA scan.

What is the status of NCT03697577?

NCT03697577 is currently ACTIVE_NOT_RECRUITING.

Last reviewed 2026-05-01 · How we verify

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

NCT03697577 ACTIVE_NOT_RECRUITING

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).

Details

Lead sponsor	Montefiore Medical Center
Status	ACTIVE_NOT_RECRUITING
Enrolment	30
Start date	2019-01-08
Completion	2026-12

Conditions

Breast Cancer

Interventions

CT scans
DEXA scan

Primary outcomes

Change in Total adipose tissue (TAT) — From Baseline and 6 months after CDK 4/6 inhibitor therapy
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).

Countries

United States