Who is sponsoring NCT02608216?

NCT02608216 is sponsored by University of Pennsylvania.

What condition does NCT02608216 study?

NCT02608216 studies Breast Neoplasm, Metastatic Breast Cancer, Rb+ Breast Cancer.

What drugs are being tested in NCT02608216?

Interventions: [18F]FLT, PET/CT, ribociclib, paclitaxel.

What is the status of NCT02608216?

NCT02608216 is currently ACTIVE_NOT_RECRUITING.

Last reviewed 2025-09-02 · How we verify

[18F]Fluorothymidine (FLT) PET/CT Imaging in Rb+ Metastatic Breast Cancer Patients Undergoing LEE011 and Weekly Paclitaxel Therapy

NCT02608216 Phase 1 ACTIVE_NOT_RECRUITING

In this study positron emission tomography (PET/CT) imaging will be used to evaluate proliferative activity in sites of metastatic disease using the investigational radiotracer \[18F\]fluorothymidine (FLT).

Details

Lead sponsor	University of Pennsylvania
Phase	Phase 1
Status	ACTIVE_NOT_RECRUITING
Enrolment	20
Start date	2015-11
Completion	2026-11

Conditions

Breast Neoplasm
Metastatic Breast Cancer
Rb+ Breast Cancer

Interventions

[18F]FLT
PET/CT
ribociclib
paclitaxel

Primary outcomes

Measure changes in [18F]FLT uptake in metastatic tumors before and during treatment with ribociclib (LEE011) only, patient will have FLT PET/CT scan at baseline, run-in day -3, and cycle 1, day 1 of ribociclib (LEE011)/paclitaxel therapy — 4 years
Measure changes in \[18F\]FLT uptake in metastatic tumors before and during treatment with ribociclib (LEE011) only and associate these changes with response to ribociclib (LEE011)/paclitaxel therapy.

Countries

United States