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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Beijing Cancer Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Beijing Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01198301
First received: September 9, 2010
Last updated: July 21, 2011
Last verified: August 2010

September 9, 2010
July 21, 2011
August 2010
July 2012   (final data collection date for primary outcome measure)
Chemotherapy response [ Time Frame: four-months ] [ Designated as safety issue: Yes ]
Response to chemotherapy is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines
Chemotherapy response [ Time Frame: Chemotherapy response is evaluated after two cycles of chemotherapy ] [ Designated as safety issue: Yes ]
Response to chemotherapy is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines
Complete list of historical versions of study NCT01198301 on ClinicalTrials.gov Archive Site
  • Time to disease progression [ Time Frame: six months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    clinical benefit response include CR,PR,SD
  • Time to disease progression [ Time Frame: Time to disease progression is measured from the date therapy is initiated to the date of documented disease progression. ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: Overall survival is measured from the date therapy is initiated to the date of death or final follow-up. ] [ Designated as safety issue: Yes ]
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Gene Expression Profiling of Metastatic Breast Cancer Predict the Therapeutic Response to Chemotherapy
Gene Expression Profiling of Metastatic Breast Cancer Predict the Therapeutic Response to Chemotherapy

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

  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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

the tissue will be obtained by core niddle biopsy.

Probability Sample

female patients with metastatic breast cancer treated by Docetaxel-based chemotherapy

  • Breast Neoplasms
  • Neoplasm Metastasis
Not Provided
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
July 2013
July 2012   (final data collection date for primary outcome measure)

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.
Female
18 Years to 75 Years
No
Contact: Jun Ren, MD +86-10-88196356 renjun9688@yahoo.com
Contact: Zheng Wang, PhD +86-10-88196328 azhengsmile@yahoo.com.cn
China
 
NCT01198301
GEP
Yes
Jun Ren/Director of the Medical Oncology Department, Beijing Cancer Hospital
Beijing Cancer Hospital
Not Provided
Principal Investigator: Zheng Wang, PhD Beijing Cancer Hospital
Study Chair: Jun Ren, MD Beijing Cancer Hospital
Beijing Cancer Hospital
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP