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
NCT number | NCT01116869 |
Other study ID # | 200901 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 25, 2010 |
Est. completion date | January 6, 2014 |
Verified date | November 2019 |
Source | Johnson & Johnson Medical, China |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 500 |
Est. completion date | January 6, 2014 |
Est. primary completion date | June 22, 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | 307 Hosptial of PLA | Beijing |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Medical, China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ability of CTC levels to predict progression-free survival (PFS) in MBC patients. | 12 months | ||
Secondary | Ability of CTC levels to predict overall survival (OS) in MBC patients. | 3 years | ||
Secondary | Agreement between CTC counts (3-4 weeks and 6-8 weeks) after the initiation of a new line of systemic therapy and the patient's response as determined by imaging evaluation (6-8 weeks after the initiation of therapy) in MBC patients. | 12 months |
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