China CellSearch Study

NCT01116869 | Completed DMC

• 1 other identifier: 200901
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Breast Cancer; Benign Breast Disease

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

Outcome Measures

Primary Outcomes (1)

• Ability of CTC levels to predict progression-free survival (PFS) in MBC patients.

  12 months

Secondary Outcomes (2)

• Ability of CTC levels to predict overall survival (OS) in MBC patients.

  3 years

• 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

Study Arms (3)

MBC patients

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.

Benign disease volunteers

100 Benign disease volunteers whom will donate blood 1 time for CTC analysis, will be enrolled as controls.

Healthy volunteers

100 Healthy volunteers whom will donate blood 1 time for CTC analysis, will be enrolled as controls.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Medical, China: lead

Study Sites (1)

307 Hosptial of PLA

Beijing, China

Location

MeSH Terms

Conditions

Breast Neoplasms; Cystic Fibrosis; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Zefei Jiang, Doctor

  307 Hosptial of PLA

  STUDY CHAIR

• Zhimin Shao, Doctor

  Shanghai Cancer Hosptial

  PRINCIPAL INVESTIGATOR

• Tao Ouyang, Doctor

  Beijing Cancer Hosptial

  PRINCIPAL INVESTIGATOR

• Erwei Song, Doctor

  Zhongshan 2nd Hospital

  PRINCIPAL INVESTIGATOR

• Ning Liao, Doctor

  The Second People's Hospital of GuangDong Province

  PRINCIPAL INVESTIGATOR

• Xiaojia Wang, Doctor

  Zhejiang Cancer Hosptial

  PRINCIPAL INVESTIGATOR

• Zhongsheng Tong, Doctor

  Tianjin Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2010
• First Posted: May 5, 2010
• Study Start: March 25, 2010
• Primary Completion: June 22, 2011
• Study Completion: January 6, 2014
• Last Updated: November 15, 2019

Record last verified: 2019-11

Locations

CN (1)