NSABP B-64/ EXActDNA-003 Breast Cancer Clinical Validation Study

The Sponsor of this study is developing a lab test (called Oncodetect™) that is designed to detect biomarkers in the blood that indicate a small amount of remaining or recurrent breast cancer in the body. A biomarker is found in blood, other body fluids, or tissues related to traces of cancer remaining after cancer treatments, or cancer that has returned (recurrent) after curative treatments were received. This could prove to be useful for guiding treatment decisions during and after pre-surgery drug therapy, surgery, post-surgery drug therapy and radiation therapy (if radiation therapy is given). It could also be a way to detect cancer recurrence earlier than the currently available methods used.

Saliva, tumor tissue, and blood samples will be collected during the study. Blood draws will be completed in the clinic during regular cancer care visits. No investigational drug is being tested.

In order to participate you must meet the following criteria:

• Are ≥ 18 years of age.
• Have an ECOG performance status 0 or 1.
• Have histologically confirmed invasive carcinoma of the breast.
• Have planned neoadjuvant therapy which includes cytotoxic chemotherapy.
• Have a tumor size ≥ 2.1 cm in greatest diameter.

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

• Have definitive clinical or radiologic evidence of metastatic disease.
• Have initiated neoadjuvant therapy for current breast cancer diagnosis.
• Have synchronous diagnosis of another invasive cancer, other than this breast cancer, except for non-melanoma skin cancers.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.