[18F]FES PET/CT in Endocrine Refractory Breast Cancer

Launched by UNIVERSITY OF PENNSYLVANIA · Mar 31, 2015

Keywords

ClinConnect Summary

This clinical trial is investigating a special type of imaging called positron emission tomography (PET/CT) to see how active estrogen receptors are in patients with advanced breast cancer that has not responded to standard hormone treatments. The study uses a specific imaging agent called \[18F\]fluoroestradiol (FES) to help doctors understand how well the cancer is responding to treatment. It is focused on women aged 18 and older who have recurrent or metastatic breast cancer that is known to be estrogen receptor positive (ER+), meaning the cancer cells grow in response to estrogen.

To be eligible for this study, participants must have evidence of breast cancer that has spread to other parts of the body and have a history of disease progression while on hormone therapy. Women who are pregnant, have certain serious medical conditions, or have a specific type of breast cancer called HER2 positive are not eligible. If they join the study, participants can expect to undergo PET/CT scans to help gather important information about their cancer. This research may lead to better ways of understanding and treating breast cancer that does not respond to traditional therapies.

Gender

FEMALE

Eligibility criteria

• 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 be willing to provide written informed consent and participate in this study 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