FES-PET for Patients Treated on NCI Protocol 8762
A significant number of all invasive breast cancers are hormone sensitive and may be candidates for treatment with hormonal therapy.
This project will assess the ability and usefulness of imaging hormone-receptor status in breast cancer with positron emission tomography (PET) and 6α-[18F]fluoro-17β-estradiol (FES), an estrogen analogue in patients who are scheduled to be treated with hormonal therapy given in combination with a selective allosteric inhibitor of AKT protein kinase (MK2206) .
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Positron Emission Tomography (PET) With 18F-Fluoroestradiol (FES) as a Predictor of Response in Patients With Breast Cancer Scheduled to be Treated With MK-2206 in Combination With Either an Aromatase Inhibitor or Fulvestrant on NCI Protocol 8762|
- FES baseline tumor SUV measurement [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Optional Diagnostic Imaging
Optional diagnostic imaging FES-PET/CT imaging
Drug: Diagnostic Imaging ( 6α-[18F]fluoro-17β-estradiol (FES))
Approximately 75% of all invasive breast cancers are hormone sensitive [estrogen-receptor positive (ER+) or progesterone-receptor positive (PR+)] and patients with such cancers are candidates for endocrine therapy. Endocrine therapy is a central component of the treatment of hormone-sensitive breast cancer in the adjuvant and, increasingly, neoadjuvant settings. Knowledge of hormone receptor expression is essential for selection of appropriate therapy. Measurement of hormone-receptor expression [estrogen receptor (ER) or progesterone receptor (PR)] using in vitro assays of the tumor tissue at the time of primary diagnosis is standard of clinical care. However, the presence of these hormone receptors predicts for clinical benefit in only 30-50% of women with advanced disease receiving first-line endocrine therapy and 15-30% receiving second-line therapy (1-3). Thus, the presence of a hormone receptor does not indicate that the receptor is functional and essential to the growth of the cancer cell, nor does it imply that interference with receptor function will result in tumor cell kill. There are several shortcomings of the in vitro assays and neither quantitative nor qualitative receptor assays performed on samples of tumor tissue completely predict the response to antiestrogen therapy in breast cancers. In addition, none of the current clinical tools (serologies, prognostic factors, or radiologic studies) can accurately predict for clinical benefit from endocrine therapy. Accordingly, better methods for predicting clinical response to antiestrogen therapy need to be developed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01714128
|United States, Missouri|
|Mallinckrodt Institute of Radiology|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Farrokh Dehdashti, M.D.||Washington Univesity in St. Louis|