Active, not recruiting • Phase I • Stage IV • Post-Menopausal • Interventional
The following is imported from ClinicalTrials.gov:
[18F]FLT PET/CT in Rb+ Metastatic Breast Cancer
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).
This protocol is designed to develop relationships between parameters determined from imaging biomarker studies and ones used for determination of therapeutic response to combined CDK4 Inhibitor and chemotherapy regimens. 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) and a third FLT PET/CT scan on cycle 1 day 12 following two treatments of weekly Paclitaxel to compare changes in FLT uptake measures.
Breast Cancer
Study Design
Study type:
Interventional
Estimated enrollment:
20 participant
Actual study start date:
November 20, 2015
Eligibility Criteria
Ages eligible for study:
18 - 999
Sexes eligible for study:
both
Arms and Intervention
[18F]FLT
PET/CT
ribociclib
paclitaxel
Inclusion criteria
at least 18 years of age
history of histologically or cytologically confirmed breast cancer, any er, pr or her2 status is allowed as long as it expresses the rb protein.
at least one site of metastatic breast cancer that is outside of the liver and bone that is identified by standard imaging (e.g. ct, mri, fdg pet/ct, ultrasound, x-ray)
participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.
patients must be candidates to receive treatment on the therapeutic trial upcc06115, a phase i study of ribociclib (lee011) and weekly paclitaxel.
Exclusion criteria
females who are pregnant at the time of screening will not be eligible for this study, urine pregnancy test will be performed at screening in women of child-bearing potential.
inability to tolerate imaging procedures in the opinion of an investigator or treating physician
serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
ineligible for the therapeutic trial upcc 06115
Trial Information at Site
Last Updated:
Trial Information
ClinicalTrial.gov ID:
Active, not recruiting
Estimated Enrollment:
20
Last Updated:
08/27/2023
Principal Investigator
David Mankoff, MD, PhD
Trial Sponsor
University of Pennsylvania
Study Location (1)
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
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