Purged Circulating Tumor Cells (CTCs) From Metastatic Breast Cancer
Condition: Breast Cancer; Metastatic Breast Carcinoma; Invasive Breast Carcinoma
MeSH terms: Carcinoma; Breast Neoplasms; Neoplastic Cells, Circulating
Intervention: Carboplatin; Cyclophosphamide; Thiotepa; Stem Cell Transplant
Intervention description: Target Area Under the Curve (AUC) of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.; 1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.; 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.; Stem Cell Transplant on Day 0.
Intervention MeSH terms: Cyclophosphamide; Thiotepa; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Breast Cancer; breast carcinoma; Carboplatin; Paraplatin; Cyclophosphamide; Neosar; Cytoxan; Thiotepa; Purged Autologous Stem Cells; Circulating Tumor Cells; CTCs

Summary:

      The goal of this clinical research study is to learn the relationship of high-dose
      chemotherapy (HDCT) and circulating tumor cells (CTCs) in controlling metastatic breast
      cancer. The study also will investigate the role of CTCs in breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 to 55 years old

          2. Metastatic breast carcinoma.

          3. Histological confirmation of invasive breast carcinoma

          4. Complete or partial response to pre-transplant standard-dose chemotherapy, or hormonal
             therapy. For bone disease, stable disease (SD) is allowed.

          5. Patient must have tumor assessed for estrogen-receptor (ER) and progesterone-receptor
             (PR).

          6. Persistent detectable or non-detectable CTCs by Veridex Technology after completion of
             standard therapy.

          7. Zubrod performance status 0 or 1.

          8. Patients must have adequate hematological parameters (White Blood Count/WBC >=
             3,000/mm3; platelet count >= 100,000/mm3)

          9. Adequate renal function (serum creatinine <= 1.5mg/dl)

         10. Adequate liver function (total bilirubin, serum glutamate pyruvate transaminase (SGPT)
             <= 2 times normal).

         11. Adequate cardiac function (Left ventricular ejection fraction (LVEF)>= 50%).

         12. Adequate pulmonary function (Carbon Monoxide Diffusing Capacity (DLCO)>= 50% of
             predicted value).

         13. Females of childbearing (women who are post-menopausal < 1 year, not surgically
             sterilized, or not abstinent) potential must use adequate contraception.

         14. Patients must sign an informed consent.

        Exclusion Criteria:

          1. Prior HDCT with Autologous hematopoietic stem cell transplantation (AHST) in adjuvant
             setting.

          2. History or presence of brain/leptomeningeal metastasis.

          3. History of other malignancies except cured non-melanoma skin cancer or cured cervical
             carcinoma in situ.

          4. 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.

          5. Clinically significant active infections (patient requiring IV antibiotics,
             uncontrolled infections, or hospitalized due to infections).

          6. HIV infection.

          7. Pregnant or lactating women.

          8. 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.