China CellSearch Study
Condition: Metastatic Breast Cancer; Benign Breast Disease
MeSH terms: Breast Diseases; Fibrocystic Breast Disease
Study type: Observational

Summary: 
      The study is designed to confirm the current indication (below) of the CellSearch®
      Circulating Tumor Cell Kit in metastatic breast cancer (MBC) patients for use of the kit in
      China.

      The CellSearch® Circulating Tumor Cell Kit is intended for the enumeration of circulating
      tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+)
      in whole blood.

      The presence of CTC in the peripheral blood, as detected by the CellSearch® Circulating Tumor
      Cell Kit, is associated with decreased progression free survival and decreased overall
      survival in patients treated for metastatic breast cancer. This test is to be used as an aid
      in the monitoring of patients with metastatic breast cancer. Serial testing for CTC should be
      used in conjunction with other clinical methods for monitoring metastatic breast cancer.
      Evaluation of CTC at any time during the course of disease allows assessment of patient
      prognosis and is predictive of progression free survival and overall survival.
    

Detailed description: 
      A longitudinal, multi-center, prospective study will be conducted in MBC patients to evaluate
      the ability of CTC to predict the patients' prognosis. A separate population of healthy and
      benign disease subjects will serve as controls to compare the CTC incidence in this control
      group versus the MBC group at baseline. Correlation between CTC and radiographic response to
      the systemic therapies in the MBC study group will also be assessed.

      300 MBC patients, each of whom will provide a series of at least 3 blood draws (baseline, 3-4
      weeks and 6-8 weeks after the initiation of the systemic therapy) for CTC analysis, will be
      enrolled. All MBC patients will be followed for a maximum of 36 months for disease
      progression and survival.

      200 healthy and benign disease volunteers, each of whom will donate blood 1 time for CTC
      analysis, will be enrolled as controls.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The hazard ratio of disease progression in patients with unfavorable versus favorable CTC
        counts at baseline, 3-4 weeks and 6-8 weeks after the initiation of therapy will be
        estimated using Cox regression.

        Kaplan-Meier plots for PFS will be constructed using the favorable and unfavorable CTC
        patient groups. The log-rank test will be used to determine if the curves for the two CTC
        groups are statistically significantly different.

        The hazard ratio of death in patients with unfavorable versus favorable CTC counts at each
        blood draw time point will be estimated using Cox regression. Kaplan-Meier plots for OS
        will be constructed using the favorable and unfavorable CTC patient groups.
      
Keywords: MBC; Healthy; Benign disease; Confirmed metastatic breast cancer patient with at least one measurable solid tumor according to the RECIST guideline; Medical examinations detect no breast benign and malignant tumors; Benign Breast Disease; Pathology diagnosed breast benign tumor disease