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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jun Ren, Beijing Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01198301
First received: September 9, 2010
Last updated: July 22, 2015
Last verified: July 2015

September 9, 2010
July 22, 2015
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
July 2012
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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01198301
GEP
Yes
Not Provided
Not Provided
Jun Ren, 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
July 2015

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