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Taxane
FLT PET/CT Imaging for Breast Cancer
Phase 1
Waitlist Available
Led By David Mankoff, MD, PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 18 years of age
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Study Summary
This trial will use PET/CT imaging to look at how well an investigational drug, [18F]fluorothymidine (FLT), works in treating people with metastatic cancer.
Who is the study for?
This trial is for adults with metastatic breast cancer that tests positive for the Rb protein. They must be able to receive ribociclib and paclitaxel treatment, have at least one tumor outside of liver and bone detectable by standard imaging, and provide informed consent. Pregnant women or those with serious health or psychological issues are excluded.Check my eligibility
What is being tested?
The study is testing how well a special type of PET/CT scan using [18F]FLT can show the growth activity in metastatic breast cancer sites. Participants will also be treated with the chemotherapy drug paclitaxel and the targeted therapy ribociclib.See study design
What are the potential side effects?
Possible side effects include reactions to the tracer used in PET/CT scans, as well as common chemotherapy-related effects like nausea, fatigue, hair loss from paclitaxel; plus potential risks from ribociclib such as low blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have breast cancer that has spread to an area other than the liver or bones.
Select...
I am eligible for the UPCC06115 trial with ribociclib and paclitaxel.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Secondary outcome measures
Measure changes in [18F]FLT uptake in metastatic tumors during and after 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
Trial Design
1Treatment groups
Experimental Treatment
Group I: FLT PET/CTExperimental Treatment4 Interventions
All subjects will receive an [18F]FLT PET/CT scan.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Ribociclib
FDA approved
PET/CT
2022
Completed Phase 3
~1270
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,016 Previous Clinical Trials
42,874,076 Total Patients Enrolled
28 Trials studying Breast Cancer
26,370 Patients Enrolled for Breast Cancer
David Mankoff, MD, PhDPrincipal InvestigatorUniversity of Pennsylvania
3 Previous Clinical Trials
110 Total Patients Enrolled
1 Trials studying Breast Cancer
30 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My breast cancer has been confirmed by tests and shows Rb protein.I have breast cancer that has spread to an area other than the liver or bones.I am eligible for the UPCC06115 trial with ribociclib and paclitaxel.I am not pregnant and will take a pregnancy test if capable of becoming pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: FLT PET/CT
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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