The purpose of this clinical study is to demonstrate that the Parsortix™ PC1 system enables the capture and harvest of circulating tumor cells (CTCs) from the peripheral blood of patients with metastatic breast cancer (MBC) and not from healthy volunteers (HVs). The study is also designed to demonstrate that the CTCs harvested by the Parsortix PC1 system from MBC patients can be used effectively for different types of evaluations (e.g. cytopathology, FISH, qPCR, RNAseq, etc.).

This is an investigational study. The Parsortix PC1 system is not FDA approved and is currently being used for research purposes only.

Approximately 200 evaluable MBC patients (either newly diagnosed or patients with progressive/recurrent disease who are about to start a new line of therapy for the treatment of their disease) and 200 evaluable healthy volunteer (HV) subjects (healthy women with no history of cancer) will be enrolled at a minimum of three (3) US based clinical sites. Each subject will have information about their age race/ethnicity, height and weight, menopausal status, smoking status, pregnancy and/or nursing status, and a brief medical history captured at the time of enrollment. Blood will be drawn from each subject into three different EDTA tubes (minimum of ~7mL up to a maximum of ~23mL of whole blood) specifically for the purposes of this study. One of the blood tubes collected will be used for a complete blood count (CBC) with differential testing, while the other two tubes of blood will be processed on the Parsortix PC1 system for the capture and harvest of CTCs. The cells harvested from one of the blood tubes will be deposited onto a glass slide and automated Wright-Giemsa staining will be done to allow for identification of CTCs based on their cytologic features (e.g. size, shape, nuclear to cytoplasmic ratio, chromatin structure, etc.) by an expert cytopathologist. The cells harvested from the remaining blood tube will be used for one of three different evaluations: Fluorescence in-situ hybridization (FISH) for evaluation of Her-2/neu gene amplification, quantitative reverse-transcriptase real-time PCR (qRT-PCR) for evaluation of cancer related gene expression, or whole transcriptome sequencing (RNAseq) for determination of the expression patterns of breast cancer related genes.

MBC Patient Inclusion Criteria

• Female >=22 years of age;

• Documented evidence of metastatic breast cancer (i.e. primary tumor histopathology of breast cancer and documented evidence of distant sites of metastasis by imaging, biopsy, or other means) that is either newly diagnosed or currently progressing / recurrent (disease progression / recurrence may be determined by any means, including RECIST v1.1 criteria, physical signs and symptoms, rising tumor markers, physician determination, etc.);

  • If newly diagnosed, have not yet started a new line of therapy of any type (e.g. hormonal, cytotoxic, targeted, etc.) for the treatment and/or management of their metastatic breast cancer;
  • If progressing or recurrent, any number of prior hormonal therapies, chemotherapies and/or biological/targeted therapies are allowed;

• Willing and able to provide informed consent and agree to complete all aspects of the study.

MBC Patient Exclusion Criteria

• Female subjects <=21 years old or male subjects;
• Concurrent other malignancies (except for a second primary breast cancer);
• Less than seven days since last administration of a cytotoxic agent;
• Unwilling or unable to provide informed consent or high risk that subject may not comply with protocol requirements.

HV Inclusion Criteria

• Females >=22 years of age;
• No known fever or active infections at the time of the blood collection;
• No known current diagnosis of acute inflammatory disease or chronic inflammation;
• No known current and/or prior history of malignancy, excluding skin cancers (squamous cell or basal cell);
• Willing and able to provide informed consent and agree to complete all aspects of the study.

HV Exclusion Criteria

• Female subjects <=21 years old or male subjects;
• Known illness at the time of the blood collection;
• Known current and/or prior history of malignancy, excluding skin cancers (squamous cell or basal cell);
• Unwilling or unable to provide informed consent or high risk that subject may not comply with protocol requirements (e.g. due to health and/or participation in other research studies).

Healthy Volunteers: Female subjects at outpatient clinics whom a delegated physician and/or study coordinator believe may be eligible for the study will be approached by the delegated physician and/or study coordinator during their scheduled gynecology appointment or, if they are accompanying a breast cancer patient, during the scheduled appointment of the individual they are accompanying.

Metastatic Breast Cancer Patients: Eligible female subjects at outpatient clinics and/or under the care of investigators at the participating medical centers will be prospectively identified by the site principal investigator, sub-investigators, nurses and/or study coordinator.