[18F]Fluoroestradiol (FES) PET/CT Imaging to Evaluate in Vivo Estrogen Receptor Activity in Endocrine Refractory Recurrent or Metastatic Breast Cancer

Metastatic ER+ Breast Cancer Clinical Trial

Official title:

[18F]Fluoroestradiol (FES) PET/CT Imaging to Evaluate in Vivo Estrogen Receptor Activity in Endocrine Refractory Recurrent or Metastatic Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02559544
• Other study ID #: UPCC 20114
• Status: Recruiting
• Phase: N/A
• Start date: May 2015
• Est. completion date: May 2019

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

Evaluate [18F]FES PET/CT uptake as a predictor of progression free survival in endocrine refractory recurrent or metastatic breast cancer patients starting a new therapy regimen including endocrine targeted therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. At least 18 years of age

2. Recurrent or metastatic cancer that is of known or suspected breast origin - may be biopsy proven or identified on standard imaging (e.g. CT, bone scan, MRI, FDG PET/CT)

3. History of ER+ pathology (ER+ may be confirmed from surgery or biopsy of primary breast cancer or lymph nodes, and/or surgery or biopsy of a metastatic site, metastatic biopsy is not required)

4. At least one site of disease outside of the liver that is seen on standard imaging (e.g. CT, bone scan, MRI, FDG PET/CT); patients with measurable or nonmeasurable disease are allowed.

5. History of progression or recurrence of disease while on an endocrine targeted therapy containing regimen as assessed by medical record review of breast cancer history at screening

6. 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.

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. History of HER2/neu positive cancer (IHC 3+ and/or FISH positive) as assessed by medical record review at screening

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic ER+ Breast Cancer
• Recurrent ER+ Breast Cancer

Intervention

Radiation:
• [18F]Fluoroestradiol (FES) PET/CT Imaging

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