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

Metastatic Breast Cancer Clinical Trial

Official title:

[18F]Fluorothymidine (FLT) PET/CT Imaging in Rb+ Metastatic Breast Cancer Patients Undergoing LEE011 and Weekly Paclitaxel Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02608216
• Other study ID #: 822997
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 2015
• Est. completion date: November 2024

Study information

• Verified date: August 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Other known NCT identifiers

• NCT02774473

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms
• Metastatic Breast Cancer
• Rb+ Breast Cancer

Intervention

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

Device:
• PET/CT
[18F]FLT PET/CT scan

Drug:
• ribociclib
therapeutic
• paclitaxel
therapeutic

Locations

Country	Name	City	State
United States	University of Pennsylvania Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	4 years
Secondary	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	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.	4 years