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Sponsor: Johnson & Johnson Medical, China
Conditions: Metastatic Breast Cancer, Benign Breast Disease
Countries: China
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.
Sex: FEMALE
Age: 18 Years to 70 Years
Healthy volunteers: Yes
Study type: OBSERVATIONAL
Inclusion Criteria * Female * over 18 and less than 70 years of age * Subject having agreed to participate in the study and follow the study procedures by providing written informed consent prior entering the study. * For MBC Subject Set only Confirmed metastatic breast cancer patient with at least one measurable solid tumor according to the RECIST guideline Starting a new line of systemic therapy which is recommended in the Chinese edition of NCCN Clinical Practice Guidelines in Oncology Breast Cancer Guideline 2009 line of chemotherapy should be over 3 ECOG performance grade of 0 to 2 Life expectancy over 3 months * For Healthy Subject Set only Medical examinations detect no breast benign and malignant tumors * For Benign Breast Disease Subject Set only Pathology diagnosed breast benign tumor disease Exclusion Criteria * Self reported pregnancy * For MBC Subject Set only Prior history of other malignancy Patients who have surgery to remove any metastatic lesions or receive radiation therapy during her participation in the study * For Healthy Subject Set only Prior history of breast benign tumor disease or any malignancy Any conditions inappropriate for blood drawing * For Benign Breast Disease Subject Set only Prior history of any malignancy Any conditions inappropriate for blood drawing
- Beijing, China