Gene Expression Profiling of Metastatic Breast Cancer Predict the Therapeutic Response to Chemotherapy

Completed

• Conditions: Neoplasm Metastasis; Breast Neoplasms

• Registration Number: NCT01198301
• Lead Sponsor: Peking University Cancer Hospital & Institute

Brief Summary

The investigators want to develop a gene expression profile the for prediction the chemotherapeutic response of patients with metastatic breast cancer.

Detailed Description

1. Metastatic breast cancer tissue is obtained from core needle biopsies pretreatment and is flash frozen and stored at -70℃ until processing.

2. After patients received docetaxel combination thiotepa for two cycles, response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines. Degree of response is used to divide the cancers into two groups-sensitive and resistant tumours.

3. The gene expression in metastatic breast cancer tissue sample is detected by microarray to screen gene markers that are differently expressed between groups

4. Statistical analysis is performed using unsupervised hierarchical cluster.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-09-09
• Study First Submitted QC: 2010-09-09
• Study First Posted: 2010-09-10
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-22
• Last Update Posted: 2015-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

Inclusion Criteria

• Patients should be histologically confirmed with metastatic breast cancer;
• Patients who had completed the planned chemotherapy regimen with no major protocol violation;
• an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
• At least one measurable lesion;
• Normal cardiac, hepatic, renal and bone marrow functions;
• Life expectancy ≥3 months;
• Discontinuity of previous chemotherapy for a minimum of 4 weeks.

Exclusion Criteria

• previous history of other malignancies;
• previous surgery history on the needle biopsy organ;
• Central nervous system metastases;
• Serious or uncontrolled concurrent medical illness.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Chemotherapy response	four-months	Response to chemotherapy is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines

Secondary Outcome Measures

Name	Time	Method
clinical benefit response	six months to one year	clinical benefit response include CR,PR,SD
Time to disease progression	six months	Time to disease progression is measured from the date therapy is initiated to the date of documented disease progression.
Overall survival	one year	Overall survival is measured from the date therapy is initiated to the date of death or final follow-up.

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, China