A Prospective Longitudinal Breast Cancer Study

The study objectives are described below:

• Obtain serum and plasma specimens longitudinally collected from a minimum of 130 subjects diagnosed with breast cancer and are about to or are currently undergoing treatment and follow-up. Specimens will be used to evaluate CA 15-3 assays, currently under development, as an aid for monitoring recurrence or progressive disease.
• To store any remaining specimens for use in future cancer research and to evaluate as yet undetermined biomarkers for the development of IVDs, including additional CA 15-3 assays, for monitoring the course of disease and therapy in subjects diagnosed with breast cancer.

Inclusion criteria

• Males and females, age≥ 18 years
• Histologic/pathologic confirmation of breast cancer
• Any stage of disease: Newly diagnosed, stable, disease progression, surveillance
• Any treatment time point: Treatment naïve, currently receiving or completed therapy for breast cancer including active monitoring.
• Individuals with a history of malignant disease other than breast cancer that was resected greater than 5 years ago and are currently in remission are eligible.
• Able to understand and willing to provide informed consent

Exclusion criteria

• Males and females, age <18 years
• No histologic/pathologic confirmation of breast cancer
• Any concurrent malignancy other than basal or squamous cell skin cancers, in-situ cervical cancer, or breast cancer.
• Treatment plan with fewer than three visits expected in 3 years' time
• Unable to provide informed consent