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Active Not Recruiting
NCT02608216
[18F]FLT PET/CT in Rb+ Metastatic Breast Cancer
Conditions: Breast Neoplasm, Metastatic Breast Cancer, Rb+ Breast Cancer
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 20
Sponsor: University of Pennsylvania
Location: University of Pennsylvania Hospital Philadelphia Pennsylvania
Summary
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).
Eligibility Criteria
Inclusion Criteria:
1. At least 18 years of age
2. History of histologically or cytologically confirmed breast cancer, any ER, PR or HER2 status is allowed as long as it expresses the Rb protein.
3. 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)
4. 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.
5. Patients must be candidates to receive treatment on the therapeutic trial UPCC06115, a Phase I study of ribociclib (LEE011) and weekly paclitaxel.
Exclusion Criteria:
1. 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.
2. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
3. 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.
4. Ineligible for the therapeutic trial UPCC 06115
Source: ClinicalTrials.gov (NCT02608216). StuddyBuddy aggregates publicly available trial information.