Gene Expression Profiling of Metastatic Breast Cancer Predict the Therapeutic Response to Chemotherapy
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ClinicalTrials.gov Identifier: NCT01198301 |
Recruitment Status
:
Completed
First Posted
: September 10, 2010
Last Update Posted
: July 23, 2015
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Condition or disease |
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Breast Neoplasms Neoplasm Metastasis |
- Metastatic breast cancer tissue is obtained from core needle biopsies pretreatment and is flash frozen and stored at -70℃ until processing.
- 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.
- The gene expression in metastatic breast cancer tissue sample is detected by microarray to screen gene markers that are differently expressed between groups
- Statistical analysis is performed using unsupervised hierarchical cluster.
Study Type : | Observational |
Actual Enrollment : | 42 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Gene Expression Profiling of Metastatic Breast Cancer Predict the Therapeutic Response to Chemotherapy |
Study Start Date : | August 2010 |
Actual Primary Completion Date : | July 2012 |
Actual Study Completion Date : | July 2012 |

- Chemotherapy response [ Time Frame: four-months ]Response to chemotherapy is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines
- Time to disease progression [ Time Frame: six months ]Time to disease progression is measured from the date therapy is initiated to the date of documented disease progression.
- Overall survival [ Time Frame: one year ]Overall survival is measured from the date therapy is initiated to the date of death or final follow-up.
- clinical benefit response [ Time Frame: six months to one year ]clinical benefit response include CR,PR,SD
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01198301
China | |
Beijing Cancer Hospital | |
Beijing, China |
Principal Investigator: | Zheng Wang, PhD | Beijing Cancer Hospital | |
Study Chair: | Jun Ren, MD | Beijing Cancer Hospital |
Responsible Party: | Jun Ren, Director, Beijing Cancer Hospital |
ClinicalTrials.gov Identifier: | NCT01198301 History of Changes |
Other Study ID Numbers: |
GEP |
First Posted: | September 10, 2010 Key Record Dates |
Last Update Posted: | July 23, 2015 |
Last Verified: | July 2015 |
Keywords provided by Jun Ren, Beijing Cancer Hospital:
Metastatic Breast Neoplasms Gene Expression Profiling Drug Therapy |
Additional relevant MeSH terms:
Neoplasms Breast Neoplasms Neoplasm Metastasis Neoplasms by Site |
Breast Diseases Skin Diseases Neoplastic Processes Pathologic Processes |