Estrogen Receptor Status Study

Clinical Trial Title

Determination of estrogen receptor status in patients diagnosed with metastatic breast cancer using cell-free tumor DNA.

Clinical Trial Protocol Description:

Identification of unique genetic abnormalities in the DNA of cancer cells requires tissue sampling from a patient with an invasive procedure (such as surgical biopsy or needle biopsy). However, there is a new way of looking for these abnormalities in components in the blood which does not require tissue sampling. This allows for the same important information to be obtained through a blood test instead of requiring a biopsy. 

This study is looking for the most common genetic abnormalities in breast cancer cells related to the estrogen receptor (a hormone receptor). This information would be used to track tumor status over time and help oncologists pick the most appropriate treatments for their patient based upon information about their hormone receptor status. 

In total, 150 subjects are expected to take part in the study. The selected subjects will be divided into four different groups – called Arms - in the study. Approximately 105 subjects with metastatic breast cancer will be separated into Arm A, Arm B, and Arm C based on characteristics of their cancer. Arm D will be 45 subjects with no history of breast cancer. Subjects will have 3 blood samples taken from the arm or port (if you have a vascular access device). Blood will be drawn at the initial encounter and then 2 more times three months apart.

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

  • For cancer patients: 
    • Are a post-menopausal woman.
    • Are 18 years of age or older.
    • Have a recurrence of a previously diagnosed curable breast cancer that is now metastatic breast cancer.
  • For healthy volunteers:
    • Are a post-menopausal woman.

You will be excluded from the study if any of the following criteria apply to you:

  • For cancer patients:
    • No exclusions.
  • For healthy volunteers:
    • Have a history of cancer.

This is a partial list of inclusion and exclusion criteria.

Study Details

Clinical Trial Investigator

Melody A. Cobleigh, MD

Contact Information

Rush Cancer Center Clinical Trials Office