A Prospective Longitudinal Breast Cancer Study

A Prospective Longitudinal Study of CA 15-3 as an Aid in Monitoring Recurrence or Progressive Disease in Patients With Breast Cancer

The purpose of this study is to obtain sufficient specimens and correlating clinical data from a well-controlled prospective clinical trial collecting longitudinal specimens from subjects diagnosed with any stage of breast cancer.

The study objectives are described below:

1. 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.
2. 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