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

Breast Neoplasms 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: Recruiting

Administrative data

• NCT number: NCT02774473
• Other study ID #: UPCC 11115
• Status: Recruiting
• Phase: N/A
• Start date: February 2016

Study information

• Verified date: July 2018
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: David Mankoff, MD
• Phone: 855-216-0098
• Email: PennCancerTrials[@]emergingmed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with a history of metastatic breast cancer who are candidates for participation in the companion therapeutic trial, UPCC 06115 "A Phase I Trial of Ribociclib (LEE011) and Weekly Paclitaxel in Patients with Rb+ Advanced Breast Cancer" may be candidates for this imaging study. Patients may participate in this study if they are at least 18 years of age, most participants will be receiving care at the clinical practices of the University of Pennsylvania. Patients that meet the eligibility criteria will be approached about study participation regardless of race or ethnic background.

The investigators anticipate enrolling up to 20 participants with metastatic breast cancer who meet eligibility requirements for this study and for the companion therapy trial UPCC 06115 "A Phase I Trial of Ribociclib (LEE011) and Weekly Paclitaxel in Patients with Rb+ Advanced Breast Cancer", Accrual will likely occur over approximately 4 years.

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). 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) on Day -3 (± 1 day) and a third FLT PET/CT scan on cycle 1 day 1 (-1 day) before starting treatment with Paclitaxel to compare changes in FLT uptake measures.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

• 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) and is measurable as defined by RECIST 1.1

• 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.

• Patients must be candidates to receive treatment on the therapeutic trial UPCC06115, a Phase I study of ribociclib (LEE011) and weekly paclitaxel.

Exclusion Criteria:

• 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.

• Inability to tolerate imaging procedures in the opinion of an investigator or treating physician

• 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.

• Ineligible for the therapeutic trial UPCC 06115 Only individuals (aged 18 or over) who can understand and give informed consent will be eligible to participate in this study. Individuals who are considered to be mentally disabled will not be recruited for this study. All subjects must be able to give informed consent. We will not be using specific methods to assess decisional capacity. Economically disadvantaged persons will not be vulnerable to undue influence, patients will be informed that participation is voluntary. All individuals will be told that their choice regarding study participation will in no way change their access to clinical care. This should negate any undue influence or coercion. Children, fetuses, neonates, or prisoners are not included in this research study. It is unlikely that the researchers will encounter a patient/study participant who is pregnant during enrollment because pregnant patients may not enroll on the parent treatment protocol, UPCC06115. However, menopausal status of the study participant will be reviewed during the screening process by examining the patient's medical record; women of child-bearing potential will have a urine pregnancy test at the time of screening.

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Device:
• [18F]FLT PET/CT

Drug:
• Paclitaxel

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events		4 years