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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
History of histologically or cytologically confirmed breast cancer, any ER, PR or HER2 status is allowed as long as it expresses the Rb protein.
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 β€œYes” for the criteria below
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I am 18 years old or older.
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My breast cancer has been confirmed by tests and shows Rb protein.
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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.

Timeline

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

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
~1240

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
1,992 Previous Clinical Trials
42,875,340 Total Patients Enrolled
28 Trials studying Breast Cancer
26,360 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

Paclitaxel (Taxane) Clinical Trial Eligibility Overview. Trial Name: NCT02608216 β€” Phase 1
Breast Cancer Research Study Groups: FLT PET/CT
Breast Cancer Clinical Trial 2023: Paclitaxel Highlights & Side Effects. Trial Name: NCT02608216 β€” Phase 1
Paclitaxel (Taxane) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02608216 β€” Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently benefiting from this clinical trial?

"Enrollment for this medical trial has been concluded. It was initially posted in November of 2015 and the information was last edited on August 16th 2022. There are currently 2297 studies recruiting patients with neoplasms, breast related issues while 877 trials require participants that are receiving paclitaxel treatment."

Answered by AI

Are there any vacancies for patients who want to join this investigation?

"Clinicaltrials.gov confirms that this investigation is not actively seeking volunteers, with the original posting having been made on November 1st 2015 and last updated August 16th 2022. Although this clinical trial has no current requirements for participants, there are 3174 other medical studies currently recruiting."

Answered by AI

What maladies typically respond to treatment with paclitaxel?

"Paclitaxel is the preferred treatment for most cases of neoplasm metastasis. Additionally, this drug can be effective in treating a variety of other medical conditions including kaposi sarcoma, advanced directives, and fallopian tubes cancer."

Answered by AI

Has paclitaxel been officially sanctioned by the FDA?

"Our team at Power gave paclitaxel a score of 1, as this is an early stage clinical trial and there is only limited data available on its efficacy and safety."

Answered by AI

Are there any studies that have previously utilized paclitaxel?

"At present, 877 studies are utilizing paclitaxel. This includes 233 Phase 3 trials. Woolloongabba in Queensland is the primary site for these experiments with 47085 other locations also running them."

Answered by AI
~1 spots leftby Nov 2024