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)

Must not have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

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.

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.

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 below

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I am 18 years old or older.

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I have breast cancer that has spread to an area other than the liver or bones.

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I am eligible for the UPCC06115 trial with ribociclib and paclitaxel.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant and will take a pregnancy test if capable of becoming pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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