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[18F]FLT PET/CT in Rb+ Metastatic Breast Cancer

Sponsor
University of Pennsylvania (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02608216
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
96
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
[18F]Fluorothymidine (FLT) PET/CT Imaging in Rb+ Metastatic Breast Cancer Patients Undergoing LEE011 and Weekly Paclitaxel Therapy
Study Start Date :
Nov 1, 2015
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: FLT PET/CT

All subjects will receive an [18F]FLT PET/CT scan.

Drug: [18F]FLT
[18F]FLT PET/CT scan, imaging tracer
Other Names:
  • [18F]fluorothymidine

    • Device: PET/CT
    [18F]FLT PET/CT scan

    Drug: ribociclib
    therapeutic
    Other Names:
  • LEE011

    • Drug: paclitaxel
    therapeutic

    Outcome Measures

    Primary Outcome Measures

    1. 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 [4 years]

      Measure changes in [18F]FLT uptake in metastatic tumors before and during treatment with ribociclib (LEE011) only and associate these changes with response to ribociclib (LEE011)/paclitaxel therapy.

    Secondary Outcome Measures

    1. 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 [4 years]

      Measure changes in [18F]FLT uptake in metastatic tumors during and after treatment with ribociclib (LEE011) only and associate these changes with response to ribociclib (LEE011)/paclitaxel therapy.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Pennsylvania Hospital Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • University of Pennsylvania

    Investigators

    • Principal Investigator: David Mankoff, MD, PhD, University of Pennsylvania

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT02608216
    Other Study ID Numbers:
    • 822997
    • NCT02774473
    First Posted:
    Nov 18, 2015
    Last Update Posted:
    Aug 17, 2022
    Last Verified:
    Aug 1, 2022
    Additional relevant MeSH terms:
    Breast Neoplasms
    Paclitaxel

    Study Results

    No Results Posted as of Aug 17, 2022