Purged Circulating Tumor Cells (CTCs) From Metastatic Breast Cancer

Inclusion Criteria

• 18 to 55 years old
• Metastatic breast carcinoma.
• Histological confirmation of invasive breast carcinoma
• Complete or partial response to pre-transplant standard-dose chemotherapy, or hormonal therapy. For bone disease, stable disease (SD) is allowed.
• Patient must have tumor assessed for estrogen-receptor (ER) and progesterone-receptor (PR).
• Persistent detectable or non-detectable CTCs by Veridex Technology after completion of standard therapy.
• Zubrod performance status 0 or 1.
• Patients must have adequate hematological parameters (White Blood Count/WBC >= 3,000/mm3; platelet count >= 100,000/mm3)
• Adequate renal function (serum creatinine = 50%).
• Adequate pulmonary function (Carbon Monoxide Diffusing Capacity (DLCO)>= 50% of predicted value).
• Females of childbearing (women who are post-menopausal < 1 year, not surgically sterilized, or not abstinent) potential must use adequate contraception.
• Patients must sign an informed consent.

Exclusion Criteria

• Prior HDCT with Autologous hematopoietic stem cell transplantation (AHST) in adjuvant setting.
• History or presence of brain/leptomeningeal metastasis.
• History of other malignancies except cured non-melanoma skin cancer or cured cervical carcinoma in situ.
• Presence of other severe medical illnesses or conditions. Severe heart disease, (myocardial ischemia, myocardial infarction, etc.) Pulmonary disease (COPD, asthma,etc). Renal failure and hepatic failure.
• Clinically significant active infections (patient requiring IV antibiotics, uncontrolled infections, or hospitalized due to infections).
• HIV infection.
• Pregnant or lactating women.
• Medical, social or psychologic factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure.