Breast Neoplasms Clinical Trial
Official title:
[18F]Fluorothymidine (FLT) PET/CT Imaging In Rb+ Metastatic Breast Cancer Patients Undergoing LEE011 And Weekly Paclitaxel Therapy
Patients with a history of metastatic breast cancer who are candidates for participation in
the companion therapeutic trial, UPCC 06115 "A Phase I Trial of Ribociclib (LEE011) and
Weekly Paclitaxel in Patients with Rb+ Advanced Breast Cancer" may be candidates for this
imaging study. Patients may participate in this study if they are at least 18 years of age,
most participants will be receiving care at the clinical practices of the University of
Pennsylvania. Patients that meet the eligibility criteria will be approached about study
participation regardless of race or ethnic background.
The investigators anticipate enrolling up to 20 participants with metastatic breast cancer
who meet eligibility requirements for this study and for the companion therapy trial UPCC
06115 "A Phase I Trial of Ribociclib (LEE011) and Weekly Paclitaxel in Patients with Rb+
Advanced Breast Cancer", Accrual will likely occur over approximately 4 years.
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). Imaging will occur prior to starting therapy on the separate therapeutic protocol UPCC
06115. Patients may undergo a second FLT PET/CT scan following a 3-day run of ribociclib
(LEE011) (day -6 to -4) on Day -3 (± 1 day) and a third FLT PET/CT scan on cycle 1 day 1 (-1
day) before starting treatment with Paclitaxel to compare changes in FLT uptake measures.
n/a
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