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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02608216
Recruitment Status : Recruiting
First Posted : November 18, 2015
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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
Breast Neoplasm Metastatic Breast Cancer Rb+ Breast Cancer Drug: [18F]FLT Device: PET/CT Drug: ribociclib Drug: paclitaxel 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 : November 2015
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Ribociclib

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 Name: [18F]fluorothymidine

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

Drug: ribociclib
therapeutic
Other Name: LEE011

Drug: paclitaxel
therapeutic




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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608216


Contacts
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Contact: Theresa Berger 215-746-2813 Theresa.berger@uphs.upenn.edu
Contact: Erin Schubert 215-573-6569 erin.schubert@uphs.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Theresa Berger    215-746-2813    theresa.berger@uphs.upenn.edu   
Contact: Erin Schubert    215-573-6569    erin.schubert@uphs.upenn.edu   
Principal Investigator: David Mankoff, MD, PHD         
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: David Mankoff, MD, PhD University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02608216    
Obsolete Identifiers: NCT02774473
Other Study ID Numbers: 822997
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action