Metastatic Breast Cancer Clinical Trial
Official title:
A Multi-Center, Prospective Study to Evaluate the Ability of CTC Enumeration Using the CellSearch® Circulating Tumor Cell Kit to Predict Prognosis and to Assess the Agreement Between CTC and Imaging Determined Response in MBC Patients 一项评价CellSearch® 循环肿瘤细胞检测试剂盒对复发转移性乳腺癌患者进行循环肿瘤细胞检测 以预测病人预后的能力及循环肿瘤细胞检测和影像学疗效判断之间一致性的多中心、前瞻性的研究
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.
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.
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